Sirolimus Use in Liver Transplant Recipients With Hepatocellular Carcinoma: A Randomized, Multicenter, Open-Label Phase 3 Trial
Identifieur interne : 002D38 ( Ncbi/Merge ); précédent : 002D37; suivant : 002D39Sirolimus Use in Liver Transplant Recipients With Hepatocellular Carcinoma: A Randomized, Multicenter, Open-Label Phase 3 Trial
Auteurs : Edward K. Geissler [Allemagne] ; Andreas A. Schnitzbauer [Allemagne] ; Carl Zülke [Allemagne] ; Philipp E. Lamby [Allemagne] ; Andrea Proneth [Allemagne] ; Christophe Duvoux [France] ; Patrizia Burra [Italie] ; Karl-Walter Jauch [Allemagne] ; Markus Rentsch [Allemagne] ; Tom M. Ganten [Allemagne] ; Jan Schmidt [Allemagne] ; Utz Settmacher [Allemagne] ; Michael Heise ; Giorgio Rossi [Italie] ; Umberto Cillo [Italie] ; Norman Kneteman [Canada] ; René Adam [France] ; Bart Van Hoek [Pays-Bas] ; Philippe Bachellier [France] ; Philippe Wolf [France] ; Lionel Rostaing [France] ; Wolf O. Bechstein [Allemagne] ; Magnus Rizell [Suède] ; James Powell [Royaume-Uni] ; Ernest Hidalgo [Royaume-Uni] ; Jean Gugenheim [France] ; Heiner Wolters [Allemagne] ; Jens Brockmann [Allemagne] ; André Roy [Canada] ; Ingrid Mutzbauer [Allemagne] ; Angela Schlitt [Allemagne] ; Susanne Beckebaum [Allemagne] ; Christian Graeb [Allemagne] ; Silvio Nadalin [Allemagne] ; Umberto Valente [Italie] ; Victor Sánchez Turri N [Espagne] ; Neville Jamieson [Royaume-Uni] ; Tim Scholz [Norvège] ; Michele Colledan [Italie] ; Fred F Ndrich [Allemagne] ; Thomas Becker [Allemagne] ; Gunnar Söderdahl [Suède] ; Olivier Chazouillères [France] ; Heikki M Kisalo [Finlande] ; Georges-Philippe Pageaux [France] ; Rudolf Steininger [Autriche] ; Thomas Soliman [Autriche] ; Koert P. De Jong [Pays-Bas] ; Jacques Pirenne [Belgique] ; Raimund Margreiter [Autriche] ; Johann Pratschke [Autriche] ; Antonio D. Pinna [Italie] ; Johann Hauss [Allemagne] ; Stefan Schreiber [Allemagne] ; Simone Strasser [Australie] ; Jürgen Klempnauer [Allemagne] ; Roberto I. Troisi [Belgique] ; Sherrie Bhoori [Italie] ; Jan Lerut [Belgique] ; Itxarone Bilbao [Espagne] ; Christian G. Klein [Allemagne] ; Alfred Königsrainer [Allemagne] ; Darius F. Mirza [Royaume-Uni] ; Gerd Otto [Allemagne] ; Vincenzo Mazzaferro [Italie] ; Peter Neuhaus [Allemagne] ; Hans J. Schlitt [Allemagne]Source :
- Transplantation [ 0041-1337 ] ; 2015.
Abstract
We investigated whether sirolimus-based immunosuppression improves outcomes in liver transplantation (LTx) candidates with hepatocellular carcinoma (HCC).
In a prospective-randomized open-label international trial, 525 LTx recipients with HCC initially receiving mammalian target of rapamycin inhibitor–free immunosuppression were randomized 4 to 6 weeks after transplantation into a group on mammalian target of rapamycin inhibitor–free immunosuppression (group A: 264 patients) or a group incorporating sirolimus (group B: 261). The primary endpoint was recurrence-free survival (RFS); intention-to-treat (ITT) analysis was conducted after 8 years. Overall survival (OS) was a secondary endpoint.
Recurrence-free survival was 64.5% in group A and 70.2% in group B at study end, this difference was not significant (
Sirolimus in LTx recipients with HCC does not improve long-term RFS beyond 5 years. However, a RFS and OS benefit is evident in the first 3 to 5 years, especially in low-risk patients. This trial provides the first high-level evidence base for selecting immunosuppression in LTx recipients with HCC.
Url:
DOI: 10.1097/TP.0000000000000965
PubMed: 26555945
PubMed Central: 4683033
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<author><name sortKey="Burra, Patrizia" sort="Burra, Patrizia" uniqKey="Burra P" first="Patrizia" last="Burra">Patrizia Burra</name>
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<author><name sortKey="Jauch, Karl Walter" sort="Jauch, Karl Walter" uniqKey="Jauch K" first="Karl-Walter" last="Jauch">Karl-Walter Jauch</name>
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<author><name sortKey="Rentsch, Markus" sort="Rentsch, Markus" uniqKey="Rentsch M" first="Markus" last="Rentsch">Markus Rentsch</name>
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<author><name sortKey="Ganten, Tom M" sort="Ganten, Tom M" uniqKey="Ganten T" first="Tom M." last="Ganten">Tom M. Ganten</name>
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<wicri:regionArea> Innere Medizin IV, Sektion Lebertransplantation, Universitätsklinikum Heidelberg, Heidelberg</wicri:regionArea>
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<author><name sortKey="Schmidt, Jan" sort="Schmidt, Jan" uniqKey="Schmidt J" first="Jan" last="Schmidt">Jan Schmidt</name>
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<author><name sortKey="Settmacher, Utz" sort="Settmacher, Utz" uniqKey="Settmacher U" first="Utz" last="Settmacher">Utz Settmacher</name>
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<country xml:lang="fr" wicri:curation="lc">Allemagne</country>
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<author><name sortKey="Heise, Michael" sort="Heise, Michael" uniqKey="Heise M" first="Michael" last="Heise">Michael Heise</name>
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<author><name sortKey="Rossi, Giorgio" sort="Rossi, Giorgio" uniqKey="Rossi G" first="Giorgio" last="Rossi">Giorgio Rossi</name>
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<affiliation wicri:level="4"><nlm:aff id="aff10"> Chirurgia Epatobiliare e Trapianto Epatico, Azienda Ospedaliera di Padova, Università di Padova, Padova, Italy.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Italie</country>
<wicri:regionArea> Chirurgia Epatobiliare e Trapianto Epatico, Azienda Ospedaliera di Padova, Università di Padova, Padova</wicri:regionArea>
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<placeName><settlement type="city">Padoue</settlement>
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<author><name sortKey="Kneteman, Norman" sort="Kneteman, Norman" uniqKey="Kneteman N" first="Norman" last="Kneteman">Norman Kneteman</name>
<affiliation wicri:level="1"><nlm:aff id="aff11"> Alberta Health Services Liver Transplant Program, University of Alberta, Edmonton, Alberta, Canada.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Canada</country>
<wicri:regionArea> Alberta Health Services Liver Transplant Program, University of Alberta, Edmonton, Alberta</wicri:regionArea>
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<author><name sortKey="Adam, Rene" sort="Adam, Rene" uniqKey="Adam R" first="René" last="Adam">René Adam</name>
<affiliation wicri:level="3"><nlm:aff id="aff12"> Centre Hépato Biliaire, Hôpital Paul Brousse, Villejuif Cedex, Paris, France.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">France</country>
<wicri:regionArea> Centre Hépato Biliaire, Hôpital Paul Brousse, Villejuif Cedex, Paris</wicri:regionArea>
<placeName><region type="region">Île-de-France</region>
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<settlement type="city">Paris</settlement>
</placeName>
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</author>
<author><name sortKey="Van Hoek, Bart" sort="Van Hoek, Bart" uniqKey="Van Hoek B" first="Bart" last="Van Hoek">Bart Van Hoek</name>
<affiliation wicri:level="3"><nlm:aff id="aff13"> Department of Gastroenterology and Hepatology, Leiden University Medical Center (LUMC), Leiden, Netherlands.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Pays-Bas</country>
<wicri:regionArea> Department of Gastroenterology and Hepatology, Leiden University Medical Center (LUMC), Leiden</wicri:regionArea>
<placeName><settlement type="city">Leyde</settlement>
<region nuts="2" type="province">Hollande-Méridionale</region>
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<author><name sortKey="Bachellier, Philippe" sort="Bachellier, Philippe" uniqKey="Bachellier P" first="Philippe" last="Bachellier">Philippe Bachellier</name>
<affiliation wicri:level="3"><nlm:aff id="aff14"> Service de Chirurgie Générale, Hépatique, Endocrinienne, et Transplantation, Hôpital de Hautepierre, Les Hôpitaux Universitaires de Strasbourg, Strasbourg, France.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">France</country>
<wicri:regionArea> Service de Chirurgie Générale, Hépatique, Endocrinienne, et Transplantation, Hôpital de Hautepierre, Les Hôpitaux Universitaires de Strasbourg, Strasbourg</wicri:regionArea>
<placeName><region type="region">Grand Est</region>
<region type="old region">Alsace (région administrative)</region>
<settlement type="city">Strasbourg</settlement>
</placeName>
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<author><name sortKey="Wolf, Philippe" sort="Wolf, Philippe" uniqKey="Wolf P" first="Philippe" last="Wolf">Philippe Wolf</name>
<affiliation wicri:level="3"><nlm:aff id="aff14"> Service de Chirurgie Générale, Hépatique, Endocrinienne, et Transplantation, Hôpital de Hautepierre, Les Hôpitaux Universitaires de Strasbourg, Strasbourg, France.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">France</country>
<wicri:regionArea> Service de Chirurgie Générale, Hépatique, Endocrinienne, et Transplantation, Hôpital de Hautepierre, Les Hôpitaux Universitaires de Strasbourg, Strasbourg</wicri:regionArea>
<placeName><region type="region">Grand Est</region>
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<settlement type="city">Strasbourg</settlement>
</placeName>
</affiliation>
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<author><name sortKey="Rostaing, Lionel" sort="Rostaing, Lionel" uniqKey="Rostaing L" first="Lionel" last="Rostaing">Lionel Rostaing</name>
<affiliation wicri:level="3"><nlm:aff id="aff15"> Service de Néphrologie-HTA-Dialyse-Transplantation, CHU Toulouse-Rangueil, Toulouse, France.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">France</country>
<wicri:regionArea> Service de Néphrologie-HTA-Dialyse-Transplantation, CHU Toulouse-Rangueil, Toulouse</wicri:regionArea>
<placeName><region type="region">Occitanie (région administrative)</region>
<region type="old region">Midi-Pyrénées</region>
<settlement type="city">Toulouse</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Bechstein, Wolf O" sort="Bechstein, Wolf O" uniqKey="Bechstein W" first="Wolf O." last="Bechstein">Wolf O. Bechstein</name>
<affiliation wicri:level="3"><nlm:aff id="aff2"> Klinik für Allgemein- und Viszeralchirurgie, Universitätsklinikum Frankfurt, Frankfurt am Main, Germany.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Allemagne</country>
<wicri:regionArea> Klinik für Allgemein- und Viszeralchirurgie, Universitätsklinikum Frankfurt, Frankfurt am Main</wicri:regionArea>
<placeName><region type="land" nuts="1">Hesse (Land)</region>
<region type="district" nuts="2">District de Darmstadt</region>
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</placeName>
</affiliation>
</author>
<author><name sortKey="Rizell, Magnus" sort="Rizell, Magnus" uniqKey="Rizell M" first="Magnus" last="Rizell">Magnus Rizell</name>
<affiliation wicri:level="1"><nlm:aff id="aff16"> Department of Surgery and Transplantation, Sahlgrenska University Hospital, Göteborg, Sweden.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Suède</country>
<wicri:regionArea> Department of Surgery and Transplantation, Sahlgrenska University Hospital, Göteborg</wicri:regionArea>
<wicri:noRegion>Göteborg</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Powell, James" sort="Powell, James" uniqKey="Powell J" first="James" last="Powell">James Powell</name>
<affiliation wicri:level="1"><nlm:aff id="aff17"> Hepatic-Pancreatico-Biliary Surgical Services and Edinburgh Transplant Unit, Royal Infirmary of Edinburgh, Edinburgh, Scotland, United Kingdom.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Royaume-Uni</country>
<wicri:regionArea> Hepatic-Pancreatico-Biliary Surgical Services and Edinburgh Transplant Unit, Royal Infirmary of Edinburgh, Edinburgh, Scotland</wicri:regionArea>
<wicri:noRegion>Scotland</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Hidalgo, Ernest" sort="Hidalgo, Ernest" uniqKey="Hidalgo E" first="Ernest" last="Hidalgo">Ernest Hidalgo</name>
<affiliation wicri:level="1"><nlm:aff id="aff17"> Hepatic-Pancreatico-Biliary Surgical Services and Edinburgh Transplant Unit, Royal Infirmary of Edinburgh, Edinburgh, Scotland, United Kingdom.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Royaume-Uni</country>
<wicri:regionArea> Hepatic-Pancreatico-Biliary Surgical Services and Edinburgh Transplant Unit, Royal Infirmary of Edinburgh, Edinburgh, Scotland</wicri:regionArea>
<wicri:noRegion>Scotland</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Gugenheim, Jean" sort="Gugenheim, Jean" uniqKey="Gugenheim J" first="Jean" last="Gugenheim">Jean Gugenheim</name>
<affiliation wicri:level="3"><nlm:aff id="aff18"> Service de Chirurgie Digestive, Centre de Transplantation Hépatique, Hôpital ARCHET 2, Centre Hospitalier Universitaire de Nice, Nice, France.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">France</country>
<wicri:regionArea> Service de Chirurgie Digestive, Centre de Transplantation Hépatique, Hôpital ARCHET 2, Centre Hospitalier Universitaire de Nice, Nice</wicri:regionArea>
<placeName><region type="region">Provence-Alpes-Côte d'Azur</region>
<region type="old region">Provence-Alpes-Côte d'Azur</region>
<settlement type="city">Nice</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Wolters, Heiner" sort="Wolters, Heiner" uniqKey="Wolters H" first="Heiner" last="Wolters">Heiner Wolters</name>
<affiliation wicri:level="3"><nlm:aff id="aff19"> Klinik für Allgemein- und Viszeralchirurgie, Universitätsklinikum Münster, Münster, Germany.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Allemagne</country>
<wicri:regionArea> Klinik für Allgemein- und Viszeralchirurgie, Universitätsklinikum Münster, Münster</wicri:regionArea>
<placeName><region type="land" nuts="1">Rhénanie-du-Nord-Westphalie</region>
<region type="district" nuts="2">District de Münster</region>
<settlement type="city">Münster</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Brockmann, Jens" sort="Brockmann, Jens" uniqKey="Brockmann J" first="Jens" last="Brockmann">Jens Brockmann</name>
<affiliation wicri:level="3"><nlm:aff id="aff19"> Klinik für Allgemein- und Viszeralchirurgie, Universitätsklinikum Münster, Münster, Germany.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Allemagne</country>
<wicri:regionArea> Klinik für Allgemein- und Viszeralchirurgie, Universitätsklinikum Münster, Münster</wicri:regionArea>
<placeName><region type="land" nuts="1">Rhénanie-du-Nord-Westphalie</region>
<region type="district" nuts="2">District de Münster</region>
<settlement type="city">Münster</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Roy, Andre" sort="Roy, Andre" uniqKey="Roy A" first="André" last="Roy">André Roy</name>
<affiliation wicri:level="1"><nlm:aff id="aff20"> Hepatobiliary and Pancreatic Surgery Unit, Hopital St Luc, Centre Hospitalier de l'Université Montréal (CHUM), Principal Pavillion, Montreal, Quebec, Canada.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Canada</country>
<wicri:regionArea> Hepatobiliary and Pancreatic Surgery Unit, Hopital St Luc, Centre Hospitalier de l'Université Montréal (CHUM), Principal Pavillion, Montreal, Quebec</wicri:regionArea>
<wicri:noRegion>Quebec</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Mutzbauer, Ingrid" sort="Mutzbauer, Ingrid" uniqKey="Mutzbauer I" first="Ingrid" last="Mutzbauer">Ingrid Mutzbauer</name>
<affiliation wicri:level="1"><nlm:aff id="aff1"> Department of Surgery and Section of Experimental Surgery, University Hospital Regensburg, Regensburg, Germany.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Allemagne</country>
<wicri:regionArea> Department of Surgery and Section of Experimental Surgery, University Hospital Regensburg, Regensburg</wicri:regionArea>
<wicri:noRegion>Regensburg</wicri:noRegion>
<wicri:noRegion>Regensburg</wicri:noRegion>
<wicri:noRegion>Regensburg</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Schlitt, Angela" sort="Schlitt, Angela" uniqKey="Schlitt A" first="Angela" last="Schlitt">Angela Schlitt</name>
<affiliation wicri:level="1"><nlm:aff id="aff1"> Department of Surgery and Section of Experimental Surgery, University Hospital Regensburg, Regensburg, Germany.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Allemagne</country>
<wicri:regionArea> Department of Surgery and Section of Experimental Surgery, University Hospital Regensburg, Regensburg</wicri:regionArea>
<wicri:noRegion>Regensburg</wicri:noRegion>
<wicri:noRegion>Regensburg</wicri:noRegion>
<wicri:noRegion>Regensburg</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Beckebaum, Susanne" sort="Beckebaum, Susanne" uniqKey="Beckebaum S" first="Susanne" last="Beckebaum">Susanne Beckebaum</name>
<affiliation wicri:level="1"><nlm:aff id="aff21"> Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Universitätsklinikum Essen, Essen, Germany.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Allemagne</country>
<wicri:regionArea> Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Universitätsklinikum Essen, Essen</wicri:regionArea>
<wicri:noRegion>Essen</wicri:noRegion>
<wicri:noRegion>Essen</wicri:noRegion>
<wicri:noRegion>Essen</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Graeb, Christian" sort="Graeb, Christian" uniqKey="Graeb C" first="Christian" last="Graeb">Christian Graeb</name>
<affiliation wicri:level="3"><nlm:aff id="aff5"> Klinik für Allgemeine, Viszeral, Transplantations- Gefäß- und Thoraxchirurgie, Klinikum der Ludwig-Maximilians-Universität München-Großhadern, München, Germany.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Allemagne</country>
<wicri:regionArea> Klinik für Allgemeine, Viszeral, Transplantations- Gefäß- und Thoraxchirurgie, Klinikum der Ludwig-Maximilians-Universität München-Großhadern, München</wicri:regionArea>
<placeName><region type="land" nuts="1">Bavière</region>
<region type="district" nuts="2">District de Haute-Bavière</region>
<settlement type="city">Munich</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Nadalin, Silvio" sort="Nadalin, Silvio" uniqKey="Nadalin S" first="Silvio" last="Nadalin">Silvio Nadalin</name>
<affiliation wicri:level="3"><nlm:aff id="aff22"> Klinik für Allgemeine, Viszeral- und Transplantationschirurgie, Klinikum der Universität Tübingen, Tübingen, Germany.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Allemagne</country>
<wicri:regionArea> Klinik für Allgemeine, Viszeral- und Transplantationschirurgie, Klinikum der Universität Tübingen, Tübingen</wicri:regionArea>
<placeName><region type="land" nuts="1">Bade-Wurtemberg</region>
<region type="district" nuts="2">District de Tübingen</region>
<settlement type="city">Tübingen</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Valente, Umberto" sort="Valente, Umberto" uniqKey="Valente U" first="Umberto" last="Valente">Umberto Valente</name>
<affiliation wicri:level="1"><nlm:aff id="aff23"> Chirurgia Generale e Trapianti d'Organo, Università di Genova-Azienda Ospedaliera Universitaria San Martino di Genova, Genova, Italy.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Italie</country>
<wicri:regionArea> Chirurgia Generale e Trapianti d'Organo, Università di Genova-Azienda Ospedaliera Universitaria San Martino di Genova, Genova</wicri:regionArea>
<wicri:noRegion>Genova</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Turri N, Victor Sanchez" sort="Turri N, Victor Sanchez" uniqKey="Turri N V" first="Victor Sánchez" last="Turri N">Victor Sánchez Turri N</name>
<affiliation wicri:level="3"><nlm:aff id="aff24"> Unidad de Trasplante Hepático, Departamento de Cirugía, Hospital Universitario Puerta de Hierro-Majadahonda, Madrid, Spain.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Espagne</country>
<wicri:regionArea> Unidad de Trasplante Hepático, Departamento de Cirugía, Hospital Universitario Puerta de Hierro-Majadahonda, Madrid</wicri:regionArea>
<placeName><settlement type="city">Madrid</settlement>
<region nuts="2" type="region">Communauté de Madrid</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Jamieson, Neville" sort="Jamieson, Neville" uniqKey="Jamieson N" first="Neville" last="Jamieson">Neville Jamieson</name>
<affiliation wicri:level="1"><nlm:aff id="aff25"> Department of Surgery, NHS Foundation Trust, Addenbrooke's Hospital, Cambridge University Hospitals, Cambridge, United Kingdom.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Royaume-Uni</country>
<wicri:regionArea> Department of Surgery, NHS Foundation Trust, Addenbrooke's Hospital, Cambridge University Hospitals, Cambridge</wicri:regionArea>
<wicri:noRegion>Cambridge</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Scholz, Tim" sort="Scholz, Tim" uniqKey="Scholz T" first="Tim" last="Scholz">Tim Scholz</name>
<affiliation wicri:level="3"><nlm:aff id="aff26"> Section for Transplant Surgery, Clinic for Cancer, Surgery and Transplantation, Department of Transplantation Medicine, Oslo University Hospital, Rikshospitalet, Oslo, Norway.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Norvège</country>
<wicri:regionArea> Section for Transplant Surgery, Clinic for Cancer, Surgery and Transplantation, Department of Transplantation Medicine, Oslo University Hospital, Rikshospitalet, Oslo</wicri:regionArea>
<placeName><settlement type="city">Oslo</settlement>
<region nuts="2">Østlandet</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Colledan, Michele" sort="Colledan, Michele" uniqKey="Colledan M" first="Michele" last="Colledan">Michele Colledan</name>
<affiliation wicri:level="1"><nlm:aff id="aff27"> Chirurgia terza e Chirurgia Toracica, Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, Italy.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Italie</country>
<wicri:regionArea> Chirurgia terza e Chirurgia Toracica, Azienda Ospedaliera Papa Giovanni XXIII, Bergamo</wicri:regionArea>
<wicri:noRegion>Bergamo</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="F Ndrich, Fred" sort="F Ndrich, Fred" uniqKey="F Ndrich F" first="Fred" last="F Ndrich">Fred F Ndrich</name>
<affiliation wicri:level="3"><nlm:aff id="aff28"> Klinik für Allgemeine Chirurgie, Viszeral-, Thorax, Transplantations- und Kinderchirurgie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel, Germany.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Allemagne</country>
<wicri:regionArea> Klinik für Allgemeine Chirurgie, Viszeral-, Thorax, Transplantations- und Kinderchirurgie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel</wicri:regionArea>
<placeName><region type="land" nuts="2">Schleswig-Holstein</region>
<settlement type="city">Kiel</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Becker, Thomas" sort="Becker, Thomas" uniqKey="Becker T" first="Thomas" last="Becker">Thomas Becker</name>
<affiliation wicri:level="3"><nlm:aff id="aff28"> Klinik für Allgemeine Chirurgie, Viszeral-, Thorax, Transplantations- und Kinderchirurgie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel, Germany.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Allemagne</country>
<wicri:regionArea> Klinik für Allgemeine Chirurgie, Viszeral-, Thorax, Transplantations- und Kinderchirurgie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel</wicri:regionArea>
<placeName><region type="land" nuts="2">Schleswig-Holstein</region>
<settlement type="city">Kiel</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Soderdahl, Gunnar" sort="Soderdahl, Gunnar" uniqKey="Soderdahl G" first="Gunnar" last="Söderdahl">Gunnar Söderdahl</name>
<affiliation wicri:level="3"><nlm:aff id="aff29"> Department of Transplantation Surgery, Karolinska University Hospital, Stockholm, Sweden.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Suède</country>
<wicri:regionArea> Department of Transplantation Surgery, Karolinska University Hospital, Stockholm</wicri:regionArea>
<placeName><settlement type="city">Stockholm</settlement>
<region nuts="2">Svealand</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Chazouilleres, Olivier" sort="Chazouilleres, Olivier" uniqKey="Chazouilleres O" first="Olivier" last="Chazouillères">Olivier Chazouillères</name>
<affiliation wicri:level="3"><nlm:aff id="aff30"> Federation d'Hepato-Gastro-Enterologie, Service d'Hepatologie, Hôpital Saint Antoine, Paris, France.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">France</country>
<wicri:regionArea> Federation d'Hepato-Gastro-Enterologie, Service d'Hepatologie, Hôpital Saint Antoine, Paris</wicri:regionArea>
<placeName><region type="region">Île-de-France</region>
<region type="old region">Île-de-France</region>
<settlement type="city">Paris</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="M Kisalo, Heikki" sort="M Kisalo, Heikki" uniqKey="M Kisalo H" first="Heikki" last="M Kisalo">Heikki M Kisalo</name>
<affiliation wicri:level="1"><nlm:aff id="aff31"> Division of Transplantation and Liver Surgery, Helsinki University Central Hospital, Helsinki, Finland.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Finlande</country>
<wicri:regionArea> Division of Transplantation and Liver Surgery, Helsinki University Central Hospital, Helsinki</wicri:regionArea>
<wicri:noRegion>Helsinki</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Pageaux, Georges Philippe" sort="Pageaux, Georges Philippe" uniqKey="Pageaux G" first="Georges-Philippe" last="Pageaux">Georges-Philippe Pageaux</name>
<affiliation wicri:level="3"><nlm:aff id="aff32"> Service d'Hepato-Gastroentérologie et Transplantation Hepatique, CHRU de Montpellier, APEMAD, Hôpital Saint-Eloi, Montpellier, France.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">France</country>
<wicri:regionArea> Service d'Hepato-Gastroentérologie et Transplantation Hepatique, CHRU de Montpellier, APEMAD, Hôpital Saint-Eloi, Montpellier</wicri:regionArea>
<placeName><region type="region">Occitanie (région administrative)</region>
<region type="old region">Languedoc-Roussillon</region>
<settlement type="city">Montpellier</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Steininger, Rudolf" sort="Steininger, Rudolf" uniqKey="Steininger R" first="Rudolf" last="Steininger">Rudolf Steininger</name>
<affiliation wicri:level="3"><nlm:aff id="aff33"> Abteilung für Transplantation, Universitätsklinik für Chirurgie, Medizinische Universität Wien, AKH-Wien, Vienna, Austria.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Autriche</country>
<wicri:regionArea> Abteilung für Transplantation, Universitätsklinik für Chirurgie, Medizinische Universität Wien, AKH-Wien, Vienna</wicri:regionArea>
<placeName><settlement type="city">Vienne (Autriche)</settlement>
<region nuts="2" type="province">Vienne (Autriche)</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Soliman, Thomas" sort="Soliman, Thomas" uniqKey="Soliman T" first="Thomas" last="Soliman">Thomas Soliman</name>
<affiliation wicri:level="3"><nlm:aff id="aff33"> Abteilung für Transplantation, Universitätsklinik für Chirurgie, Medizinische Universität Wien, AKH-Wien, Vienna, Austria.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Autriche</country>
<wicri:regionArea> Abteilung für Transplantation, Universitätsklinik für Chirurgie, Medizinische Universität Wien, AKH-Wien, Vienna</wicri:regionArea>
<placeName><settlement type="city">Vienne (Autriche)</settlement>
<region nuts="2" type="province">Vienne (Autriche)</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="De Jong, Koert P" sort="De Jong, Koert P" uniqKey="De Jong K" first="Koert P." last="De Jong">Koert P. De Jong</name>
<affiliation wicri:level="3"><nlm:aff id="aff34"> Division of Hepato-Pancreatico-Biliary Surgery and Liver Transplantation, Department of Surgery, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Pays-Bas</country>
<wicri:regionArea> Division of Hepato-Pancreatico-Biliary Surgery and Liver Transplantation, Department of Surgery, University Medical Center Groningen, University of Groningen, Groningen</wicri:regionArea>
<placeName><settlement type="city">Groningue</settlement>
<region nuts="2" type="province">Groningue (province)</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Pirenne, Jacques" sort="Pirenne, Jacques" uniqKey="Pirenne J" first="Jacques" last="Pirenne">Jacques Pirenne</name>
<affiliation wicri:level="1"><nlm:aff id="aff35"> Abdominale Transplantatiechirurgie, UZ Leuven, Campus Gasthuisberg, Leuven, Belgium.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Belgique</country>
<wicri:regionArea> Abdominale Transplantatiechirurgie, UZ Leuven, Campus Gasthuisberg, Leuven</wicri:regionArea>
<wicri:noRegion>Leuven</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Margreiter, Raimund" sort="Margreiter, Raimund" uniqKey="Margreiter R" first="Raimund" last="Margreiter">Raimund Margreiter</name>
<affiliation wicri:level="1"><nlm:aff id="aff36"> Universitätsklinik für Visceral-, Transplantations-Throaxchirurgie, Medizinische Universität Innsbruck, Innsbruck, Austria.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Autriche</country>
<wicri:regionArea> Universitätsklinik für Visceral-, Transplantations-Throaxchirurgie, Medizinische Universität Innsbruck, Innsbruck</wicri:regionArea>
<wicri:noRegion>Innsbruck</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Pratschke, Johann" sort="Pratschke, Johann" uniqKey="Pratschke J" first="Johann" last="Pratschke">Johann Pratschke</name>
<affiliation wicri:level="1"><nlm:aff id="aff36"> Universitätsklinik für Visceral-, Transplantations-Throaxchirurgie, Medizinische Universität Innsbruck, Innsbruck, Austria.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Autriche</country>
<wicri:regionArea> Universitätsklinik für Visceral-, Transplantations-Throaxchirurgie, Medizinische Universität Innsbruck, Innsbruck</wicri:regionArea>
<wicri:noRegion>Innsbruck</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Pinna, Antonio D" sort="Pinna, Antonio D" uniqKey="Pinna A" first="Antonio D." last="Pinna">Antonio D. Pinna</name>
<affiliation wicri:level="4"><nlm:aff id="aff37"> Chirurgia Generale e dei Trapianti, Policlinico S. Orsola-Malpighi, Universita di Bologna, Bologna, Italy.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Italie</country>
<wicri:regionArea> Chirurgia Generale e dei Trapianti, Policlinico S. Orsola-Malpighi, Universita di Bologna, Bologna</wicri:regionArea>
<orgName type="university">Université de Bologne</orgName>
<placeName><settlement type="city">Bologne</settlement>
<region nuts="2" type="region">Émilie-Romagne</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Hauss, Johann" sort="Hauss, Johann" uniqKey="Hauss J" first="Johann" last="Hauss">Johann Hauss</name>
<affiliation wicri:level="3"><nlm:aff id="aff38"> Klinik für Visceral-, Transplantations-, Thorax- und Gefäßchirurgie, Universitätsklinikum Leipzig, Leipzig, Germany.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Allemagne</country>
<wicri:regionArea> Klinik für Visceral-, Transplantations-, Thorax- und Gefäßchirurgie, Universitätsklinikum Leipzig, Leipzig</wicri:regionArea>
<placeName><region type="land" nuts="1">Saxe (Land)</region>
<region type="district" nuts="2">District de Leipzig</region>
<settlement type="city">Leipzig</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Schreiber, Stefan" sort="Schreiber, Stefan" uniqKey="Schreiber S" first="Stefan" last="Schreiber">Stefan Schreiber</name>
<affiliation wicri:level="3"><nlm:aff id="aff38"> Klinik für Visceral-, Transplantations-, Thorax- und Gefäßchirurgie, Universitätsklinikum Leipzig, Leipzig, Germany.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Allemagne</country>
<wicri:regionArea> Klinik für Visceral-, Transplantations-, Thorax- und Gefäßchirurgie, Universitätsklinikum Leipzig, Leipzig</wicri:regionArea>
<placeName><region type="land" nuts="1">Saxe (Land)</region>
<region type="district" nuts="2">District de Leipzig</region>
<settlement type="city">Leipzig</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Strasser, Simone" sort="Strasser, Simone" uniqKey="Strasser S" first="Simone" last="Strasser">Simone Strasser</name>
<affiliation wicri:level="1"><nlm:aff id="aff39"> AW Morrow Gastroenterology and Liver Centre and Liver Transplant Unit, Royal Prince Alfred Hospital, Sydney, NSW, Australia.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Australie</country>
<wicri:regionArea> AW Morrow Gastroenterology and Liver Centre and Liver Transplant Unit, Royal Prince Alfred Hospital, Sydney, NSW</wicri:regionArea>
<wicri:noRegion>NSW</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Klempnauer, Jurgen" sort="Klempnauer, Jurgen" uniqKey="Klempnauer J" first="Jürgen" last="Klempnauer">Jürgen Klempnauer</name>
<affiliation wicri:level="3"><nlm:aff id="aff40"> Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Medizinische Hochschule Hannover, Hannover, Germany.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Allemagne</country>
<wicri:regionArea> Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Medizinische Hochschule Hannover, Hannover</wicri:regionArea>
<placeName><region type="land" nuts="2">Basse-Saxe</region>
<settlement type="city">Hanovre</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Troisi, Roberto I" sort="Troisi, Roberto I" uniqKey="Troisi R" first="Roberto I." last="Troisi">Roberto I. Troisi</name>
<affiliation wicri:level="1"><nlm:aff id="aff41"> Hepato-Biliary and Pancreatic Surgery, Ghent University Hospital and Medical School, Ghent, Belgium.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Belgique</country>
<wicri:regionArea> Hepato-Biliary and Pancreatic Surgery, Ghent University Hospital and Medical School, Ghent</wicri:regionArea>
<wicri:noRegion>Ghent</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Bhoori, Sherrie" sort="Bhoori, Sherrie" uniqKey="Bhoori S" first="Sherrie" last="Bhoori">Sherrie Bhoori</name>
<affiliation wicri:level="3"><nlm:aff id="aff42"> Department of Surgery, Transplantation and Hepatobiliary Cancer Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, National Cancer Institute Milan, Milan, Italy.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Italie</country>
<wicri:regionArea> Department of Surgery, Transplantation and Hepatobiliary Cancer Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, National Cancer Institute Milan, Milan</wicri:regionArea>
<placeName><settlement type="city">Milan</settlement>
<region nuts="2">Lombardie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Lerut, Jan" sort="Lerut, Jan" uniqKey="Lerut J" first="Jan" last="Lerut">Jan Lerut</name>
<affiliation wicri:level="3"><nlm:aff id="aff43"> Department of Abdominal and Transplantation Surgery (SCTA), UCL Transplant Centre, University Hospitals Saint-Luc, Brussels, Belgium.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Belgique</country>
<wicri:regionArea> Department of Abdominal and Transplantation Surgery (SCTA), UCL Transplant Centre, University Hospitals Saint-Luc, Brussels</wicri:regionArea>
<placeName><settlement type="city">Bruxelles</settlement>
<region nuts="2">Région de Bruxelles-Capitale</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Bilbao, Itxarone" sort="Bilbao, Itxarone" uniqKey="Bilbao I" first="Itxarone" last="Bilbao">Itxarone Bilbao</name>
<affiliation wicri:level="3"><nlm:aff id="aff44"> Servicio de Cirugía General, Unidad de Trasplante Hepatico, Hospital Universitari Vall d'Hebron, Barcelona, Spain.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Espagne</country>
<wicri:regionArea> Servicio de Cirugía General, Unidad de Trasplante Hepatico, Hospital Universitari Vall d'Hebron, Barcelona</wicri:regionArea>
<placeName><settlement type="city">Barcelone</settlement>
<region nuts="2" type="region">Catalogne</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Klein, Christian G" sort="Klein, Christian G" uniqKey="Klein C" first="Christian G." last="Klein">Christian G. Klein</name>
<affiliation wicri:level="1"><nlm:aff id="aff21"> Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Universitätsklinikum Essen, Essen, Germany.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Allemagne</country>
<wicri:regionArea> Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Universitätsklinikum Essen, Essen</wicri:regionArea>
<wicri:noRegion>Essen</wicri:noRegion>
<wicri:noRegion>Essen</wicri:noRegion>
<wicri:noRegion>Essen</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Konigsrainer, Alfred" sort="Konigsrainer, Alfred" uniqKey="Konigsrainer A" first="Alfred" last="Königsrainer">Alfred Königsrainer</name>
<affiliation wicri:level="3"><nlm:aff id="aff22"> Klinik für Allgemeine, Viszeral- und Transplantationschirurgie, Klinikum der Universität Tübingen, Tübingen, Germany.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Allemagne</country>
<wicri:regionArea> Klinik für Allgemeine, Viszeral- und Transplantationschirurgie, Klinikum der Universität Tübingen, Tübingen</wicri:regionArea>
<placeName><region type="land" nuts="1">Bade-Wurtemberg</region>
<region type="district" nuts="2">District de Tübingen</region>
<settlement type="city">Tübingen</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Mirza, Darius F" sort="Mirza, Darius F" uniqKey="Mirza D" first="Darius F." last="Mirza">Darius F. Mirza</name>
<affiliation wicri:level="3"><nlm:aff id="aff45"> The Queen Elizabeth Hospital, Liver and Hepato-Pancreato-Biliary (HPB) Unit, NHS Foundation Trust, University Hospitals Birmingham, Edgbaston, Birmingham, United Kingdom.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Royaume-Uni</country>
<wicri:regionArea> The Queen Elizabeth Hospital, Liver and Hepato-Pancreato-Biliary (HPB) Unit, NHS Foundation Trust, University Hospitals Birmingham, Edgbaston, Birmingham</wicri:regionArea>
<placeName><settlement type="city">Birmingham</settlement>
<region type="country">Angleterre</region>
<region type="région" nuts="1">Midlands de l'Ouest</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Otto, Gerd" sort="Otto, Gerd" uniqKey="Otto G" first="Gerd" last="Otto">Gerd Otto</name>
<affiliation wicri:level="3"><nlm:aff id="aff8"> Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Mainz, Germany.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Allemagne</country>
<wicri:regionArea> Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Mainz</wicri:regionArea>
<placeName><region type="land" nuts="2">Rhénanie-Palatinat</region>
<settlement type="city">Mayence</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Mazzaferro, Vincenzo" sort="Mazzaferro, Vincenzo" uniqKey="Mazzaferro V" first="Vincenzo" last="Mazzaferro">Vincenzo Mazzaferro</name>
<affiliation wicri:level="3"><nlm:aff id="aff42"> Department of Surgery, Transplantation and Hepatobiliary Cancer Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, National Cancer Institute Milan, Milan, Italy.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Italie</country>
<wicri:regionArea> Department of Surgery, Transplantation and Hepatobiliary Cancer Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, National Cancer Institute Milan, Milan</wicri:regionArea>
<placeName><settlement type="city">Milan</settlement>
<region nuts="2">Lombardie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Neuhaus, Peter" sort="Neuhaus, Peter" uniqKey="Neuhaus P" first="Peter" last="Neuhaus">Peter Neuhaus</name>
<affiliation wicri:level="3"><nlm:aff id="aff46"> Klinik für Allgemein-, Visceral- und Transplantationschirurgie, Charité Campus Virchow Klinikum, Universitätsmedizin Berlin, Berlin, Germany.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Allemagne</country>
<wicri:regionArea> Klinik für Allgemein-, Visceral- und Transplantationschirurgie, Charité Campus Virchow Klinikum, Universitätsmedizin Berlin, Berlin</wicri:regionArea>
<placeName><region type="land" nuts="3">Berlin</region>
<settlement type="city">Berlin</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Schlitt, Hans J" sort="Schlitt, Hans J" uniqKey="Schlitt H" first="Hans J." last="Schlitt">Hans J. Schlitt</name>
<affiliation wicri:level="1"><nlm:aff id="aff1"> Department of Surgery and Section of Experimental Surgery, University Hospital Regensburg, Regensburg, Germany.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Allemagne</country>
<wicri:regionArea> Department of Surgery and Section of Experimental Surgery, University Hospital Regensburg, Regensburg</wicri:regionArea>
<wicri:noRegion>Regensburg</wicri:noRegion>
<wicri:noRegion>Regensburg</wicri:noRegion>
<wicri:noRegion>Regensburg</wicri:noRegion>
</affiliation>
</author>
</titleStmt>
<publicationStmt><idno type="wicri:source">PMC</idno>
<idno type="pmid">26555945</idno>
<idno type="pmc">4683033</idno>
<idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4683033</idno>
<idno type="RBID">PMC:4683033</idno>
<idno type="doi">10.1097/TP.0000000000000965</idno>
<date when="2015">2015</date>
<idno type="wicri:Area/Pmc/Corpus">000386</idno>
<idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">000386</idno>
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<idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Checkpoint">000D16</idno>
<idno type="wicri:Area/Ncbi/Merge">002D38</idno>
</publicationStmt>
<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Sirolimus Use in Liver Transplant Recipients With Hepatocellular Carcinoma: A Randomized, Multicenter, Open-Label Phase 3 Trial</title>
<author><name sortKey="Geissler, Edward K" sort="Geissler, Edward K" uniqKey="Geissler E" first="Edward K." last="Geissler">Edward K. Geissler</name>
<affiliation wicri:level="1"><nlm:aff id="aff1"> Department of Surgery and Section of Experimental Surgery, University Hospital Regensburg, Regensburg, Germany.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Allemagne</country>
<wicri:regionArea> Department of Surgery and Section of Experimental Surgery, University Hospital Regensburg, Regensburg</wicri:regionArea>
<wicri:noRegion>Regensburg</wicri:noRegion>
<wicri:noRegion>Regensburg</wicri:noRegion>
<wicri:noRegion>Regensburg</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Schnitzbauer, Andreas A" sort="Schnitzbauer, Andreas A" uniqKey="Schnitzbauer A" first="Andreas A." last="Schnitzbauer">Andreas A. Schnitzbauer</name>
<affiliation wicri:level="1"><nlm:aff id="aff1"> Department of Surgery and Section of Experimental Surgery, University Hospital Regensburg, Regensburg, Germany.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Allemagne</country>
<wicri:regionArea> Department of Surgery and Section of Experimental Surgery, University Hospital Regensburg, Regensburg</wicri:regionArea>
<wicri:noRegion>Regensburg</wicri:noRegion>
<wicri:noRegion>Regensburg</wicri:noRegion>
<wicri:noRegion>Regensburg</wicri:noRegion>
</affiliation>
<affiliation wicri:level="3"><nlm:aff id="aff2"> Klinik für Allgemein- und Viszeralchirurgie, Universitätsklinikum Frankfurt, Frankfurt am Main, Germany.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Allemagne</country>
<wicri:regionArea> Klinik für Allgemein- und Viszeralchirurgie, Universitätsklinikum Frankfurt, Frankfurt am Main</wicri:regionArea>
<placeName><region type="land" nuts="1">Hesse (Land)</region>
<region type="district" nuts="2">District de Darmstadt</region>
<settlement type="city">Francfort-sur-le-Main</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Zulke, Carl" sort="Zulke, Carl" uniqKey="Zulke C" first="Carl" last="Zülke">Carl Zülke</name>
<affiliation wicri:level="1"><nlm:aff id="aff1"> Department of Surgery and Section of Experimental Surgery, University Hospital Regensburg, Regensburg, Germany.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Allemagne</country>
<wicri:regionArea> Department of Surgery and Section of Experimental Surgery, University Hospital Regensburg, Regensburg</wicri:regionArea>
<wicri:noRegion>Regensburg</wicri:noRegion>
<wicri:noRegion>Regensburg</wicri:noRegion>
<wicri:noRegion>Regensburg</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Lamby, Philipp E" sort="Lamby, Philipp E" uniqKey="Lamby P" first="Philipp E." last="Lamby">Philipp E. Lamby</name>
<affiliation wicri:level="1"><nlm:aff id="aff1"> Department of Surgery and Section of Experimental Surgery, University Hospital Regensburg, Regensburg, Germany.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Allemagne</country>
<wicri:regionArea> Department of Surgery and Section of Experimental Surgery, University Hospital Regensburg, Regensburg</wicri:regionArea>
<wicri:noRegion>Regensburg</wicri:noRegion>
<wicri:noRegion>Regensburg</wicri:noRegion>
<wicri:noRegion>Regensburg</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Proneth, Andrea" sort="Proneth, Andrea" uniqKey="Proneth A" first="Andrea" last="Proneth">Andrea Proneth</name>
<affiliation wicri:level="1"><nlm:aff id="aff1"> Department of Surgery and Section of Experimental Surgery, University Hospital Regensburg, Regensburg, Germany.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Allemagne</country>
<wicri:regionArea> Department of Surgery and Section of Experimental Surgery, University Hospital Regensburg, Regensburg</wicri:regionArea>
<wicri:noRegion>Regensburg</wicri:noRegion>
<wicri:noRegion>Regensburg</wicri:noRegion>
<wicri:noRegion>Regensburg</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Duvoux, Christophe" sort="Duvoux, Christophe" uniqKey="Duvoux C" first="Christophe" last="Duvoux">Christophe Duvoux</name>
<affiliation wicri:level="3"><nlm:aff id="aff3"> Unite d‘Hepatologie et de Transplantation Hepatique, Centre Hospitalier Universitaire Henri-Mondor, Service d'Hepatologie et de Gastroenterologie, Université Paris-Est Créteil Val-de-Marne, Paris, France.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">France</country>
<wicri:regionArea> Unite d‘Hepatologie et de Transplantation Hepatique, Centre Hospitalier Universitaire Henri-Mondor, Service d'Hepatologie et de Gastroenterologie, Université Paris-Est Créteil Val-de-Marne, Paris</wicri:regionArea>
<placeName><region type="region">Île-de-France</region>
<region type="old region">Île-de-France</region>
<settlement type="city">Paris</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Burra, Patrizia" sort="Burra, Patrizia" uniqKey="Burra P" first="Patrizia" last="Burra">Patrizia Burra</name>
<affiliation wicri:level="4"><nlm:aff id="aff4"> Dipartimento di Scienze Chirurgiche, Oncologiche e Gastroenterologiche (DiSCOG), Università degli Studi di Padova, Padova, Italy.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Italie</country>
<wicri:regionArea> Dipartimento di Scienze Chirurgiche, Oncologiche e Gastroenterologiche (DiSCOG), Università degli Studi di Padova, Padova</wicri:regionArea>
<orgName type="university">Université de Padoue</orgName>
<placeName><settlement type="city">Padoue</settlement>
<region type="region" nuts="2">Vénétie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Jauch, Karl Walter" sort="Jauch, Karl Walter" uniqKey="Jauch K" first="Karl-Walter" last="Jauch">Karl-Walter Jauch</name>
<affiliation wicri:level="3"><nlm:aff id="aff5"> Klinik für Allgemeine, Viszeral, Transplantations- Gefäß- und Thoraxchirurgie, Klinikum der Ludwig-Maximilians-Universität München-Großhadern, München, Germany.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Allemagne</country>
<wicri:regionArea> Klinik für Allgemeine, Viszeral, Transplantations- Gefäß- und Thoraxchirurgie, Klinikum der Ludwig-Maximilians-Universität München-Großhadern, München</wicri:regionArea>
<placeName><region type="land" nuts="1">Bavière</region>
<region type="district" nuts="2">District de Haute-Bavière</region>
<settlement type="city">Munich</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Rentsch, Markus" sort="Rentsch, Markus" uniqKey="Rentsch M" first="Markus" last="Rentsch">Markus Rentsch</name>
<affiliation wicri:level="3"><nlm:aff id="aff5"> Klinik für Allgemeine, Viszeral, Transplantations- Gefäß- und Thoraxchirurgie, Klinikum der Ludwig-Maximilians-Universität München-Großhadern, München, Germany.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Allemagne</country>
<wicri:regionArea> Klinik für Allgemeine, Viszeral, Transplantations- Gefäß- und Thoraxchirurgie, Klinikum der Ludwig-Maximilians-Universität München-Großhadern, München</wicri:regionArea>
<placeName><region type="land" nuts="1">Bavière</region>
<region type="district" nuts="2">District de Haute-Bavière</region>
<settlement type="city">Munich</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Ganten, Tom M" sort="Ganten, Tom M" uniqKey="Ganten T" first="Tom M." last="Ganten">Tom M. Ganten</name>
<affiliation wicri:level="3"><nlm:aff id="aff6"> Innere Medizin IV, Sektion Lebertransplantation, Universitätsklinikum Heidelberg, Heidelberg, Germany.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Allemagne</country>
<wicri:regionArea> Innere Medizin IV, Sektion Lebertransplantation, Universitätsklinikum Heidelberg, Heidelberg</wicri:regionArea>
<placeName><region type="land" nuts="1">Bade-Wurtemberg</region>
<region type="district" nuts="2">District de Karlsruhe</region>
<settlement type="city">Heidelberg</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Schmidt, Jan" sort="Schmidt, Jan" uniqKey="Schmidt J" first="Jan" last="Schmidt">Jan Schmidt</name>
<affiliation wicri:level="3"><nlm:aff id="aff6"> Innere Medizin IV, Sektion Lebertransplantation, Universitätsklinikum Heidelberg, Heidelberg, Germany.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Allemagne</country>
<wicri:regionArea> Innere Medizin IV, Sektion Lebertransplantation, Universitätsklinikum Heidelberg, Heidelberg</wicri:regionArea>
<placeName><region type="land" nuts="1">Bade-Wurtemberg</region>
<region type="district" nuts="2">District de Karlsruhe</region>
<settlement type="city">Heidelberg</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Settmacher, Utz" sort="Settmacher, Utz" uniqKey="Settmacher U" first="Utz" last="Settmacher">Utz Settmacher</name>
<affiliation wicri:level="1"><nlm:aff id="aff7"> Klinik für Allgemein-, Viszeral- und Gefässchirurgie, Universitätsklinikum Jena, Jena, Germany.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Allemagne</country>
<wicri:regionArea> Klinik für Allgemein-, Viszeral- und Gefässchirurgie, Universitätsklinikum Jena, Jena</wicri:regionArea>
<wicri:noRegion>Jena</wicri:noRegion>
<wicri:noRegion>Jena</wicri:noRegion>
<wicri:noRegion>Jena</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Heise, Michael" sort="Heise, Michael" uniqKey="Heise M" first="Michael" last="Heise">Michael Heise</name>
</author>
<author><name sortKey="Rossi, Giorgio" sort="Rossi, Giorgio" uniqKey="Rossi G" first="Giorgio" last="Rossi">Giorgio Rossi</name>
<affiliation wicri:level="3"><nlm:aff id="aff9"> Centro Trapianti Fegato, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico IRCCS di Milano, Milan, Italy.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Italie</country>
<wicri:regionArea> Centro Trapianti Fegato, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico IRCCS di Milano, Milan</wicri:regionArea>
<placeName><settlement type="city">Milan</settlement>
<region nuts="2">Lombardie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Cillo, Umberto" sort="Cillo, Umberto" uniqKey="Cillo U" first="Umberto" last="Cillo">Umberto Cillo</name>
<affiliation wicri:level="4"><nlm:aff id="aff10"> Chirurgia Epatobiliare e Trapianto Epatico, Azienda Ospedaliera di Padova, Università di Padova, Padova, Italy.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Italie</country>
<wicri:regionArea> Chirurgia Epatobiliare e Trapianto Epatico, Azienda Ospedaliera di Padova, Università di Padova, Padova</wicri:regionArea>
<orgName type="university">Université de Padoue</orgName>
<placeName><settlement type="city">Padoue</settlement>
<region type="region" nuts="2">Vénétie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Kneteman, Norman" sort="Kneteman, Norman" uniqKey="Kneteman N" first="Norman" last="Kneteman">Norman Kneteman</name>
<affiliation wicri:level="1"><nlm:aff id="aff11"> Alberta Health Services Liver Transplant Program, University of Alberta, Edmonton, Alberta, Canada.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Canada</country>
<wicri:regionArea> Alberta Health Services Liver Transplant Program, University of Alberta, Edmonton, Alberta</wicri:regionArea>
<wicri:noRegion>Alberta</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Adam, Rene" sort="Adam, Rene" uniqKey="Adam R" first="René" last="Adam">René Adam</name>
<affiliation wicri:level="3"><nlm:aff id="aff12"> Centre Hépato Biliaire, Hôpital Paul Brousse, Villejuif Cedex, Paris, France.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">France</country>
<wicri:regionArea> Centre Hépato Biliaire, Hôpital Paul Brousse, Villejuif Cedex, Paris</wicri:regionArea>
<placeName><region type="region">Île-de-France</region>
<region type="old region">Île-de-France</region>
<settlement type="city">Paris</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Van Hoek, Bart" sort="Van Hoek, Bart" uniqKey="Van Hoek B" first="Bart" last="Van Hoek">Bart Van Hoek</name>
<affiliation wicri:level="3"><nlm:aff id="aff13"> Department of Gastroenterology and Hepatology, Leiden University Medical Center (LUMC), Leiden, Netherlands.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Pays-Bas</country>
<wicri:regionArea> Department of Gastroenterology and Hepatology, Leiden University Medical Center (LUMC), Leiden</wicri:regionArea>
<placeName><settlement type="city">Leyde</settlement>
<region nuts="2" type="province">Hollande-Méridionale</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Bachellier, Philippe" sort="Bachellier, Philippe" uniqKey="Bachellier P" first="Philippe" last="Bachellier">Philippe Bachellier</name>
<affiliation wicri:level="3"><nlm:aff id="aff14"> Service de Chirurgie Générale, Hépatique, Endocrinienne, et Transplantation, Hôpital de Hautepierre, Les Hôpitaux Universitaires de Strasbourg, Strasbourg, France.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">France</country>
<wicri:regionArea> Service de Chirurgie Générale, Hépatique, Endocrinienne, et Transplantation, Hôpital de Hautepierre, Les Hôpitaux Universitaires de Strasbourg, Strasbourg</wicri:regionArea>
<placeName><region type="region">Grand Est</region>
<region type="old region">Alsace (région administrative)</region>
<settlement type="city">Strasbourg</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Wolf, Philippe" sort="Wolf, Philippe" uniqKey="Wolf P" first="Philippe" last="Wolf">Philippe Wolf</name>
<affiliation wicri:level="3"><nlm:aff id="aff14"> Service de Chirurgie Générale, Hépatique, Endocrinienne, et Transplantation, Hôpital de Hautepierre, Les Hôpitaux Universitaires de Strasbourg, Strasbourg, France.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">France</country>
<wicri:regionArea> Service de Chirurgie Générale, Hépatique, Endocrinienne, et Transplantation, Hôpital de Hautepierre, Les Hôpitaux Universitaires de Strasbourg, Strasbourg</wicri:regionArea>
<placeName><region type="region">Grand Est</region>
<region type="old region">Alsace (région administrative)</region>
<settlement type="city">Strasbourg</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Rostaing, Lionel" sort="Rostaing, Lionel" uniqKey="Rostaing L" first="Lionel" last="Rostaing">Lionel Rostaing</name>
<affiliation wicri:level="3"><nlm:aff id="aff15"> Service de Néphrologie-HTA-Dialyse-Transplantation, CHU Toulouse-Rangueil, Toulouse, France.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">France</country>
<wicri:regionArea> Service de Néphrologie-HTA-Dialyse-Transplantation, CHU Toulouse-Rangueil, Toulouse</wicri:regionArea>
<placeName><region type="region">Occitanie (région administrative)</region>
<region type="old region">Midi-Pyrénées</region>
<settlement type="city">Toulouse</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Bechstein, Wolf O" sort="Bechstein, Wolf O" uniqKey="Bechstein W" first="Wolf O." last="Bechstein">Wolf O. Bechstein</name>
<affiliation wicri:level="3"><nlm:aff id="aff2"> Klinik für Allgemein- und Viszeralchirurgie, Universitätsklinikum Frankfurt, Frankfurt am Main, Germany.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Allemagne</country>
<wicri:regionArea> Klinik für Allgemein- und Viszeralchirurgie, Universitätsklinikum Frankfurt, Frankfurt am Main</wicri:regionArea>
<placeName><region type="land" nuts="1">Hesse (Land)</region>
<region type="district" nuts="2">District de Darmstadt</region>
<settlement type="city">Francfort-sur-le-Main</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Rizell, Magnus" sort="Rizell, Magnus" uniqKey="Rizell M" first="Magnus" last="Rizell">Magnus Rizell</name>
<affiliation wicri:level="1"><nlm:aff id="aff16"> Department of Surgery and Transplantation, Sahlgrenska University Hospital, Göteborg, Sweden.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Suède</country>
<wicri:regionArea> Department of Surgery and Transplantation, Sahlgrenska University Hospital, Göteborg</wicri:regionArea>
<wicri:noRegion>Göteborg</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Powell, James" sort="Powell, James" uniqKey="Powell J" first="James" last="Powell">James Powell</name>
<affiliation wicri:level="1"><nlm:aff id="aff17"> Hepatic-Pancreatico-Biliary Surgical Services and Edinburgh Transplant Unit, Royal Infirmary of Edinburgh, Edinburgh, Scotland, United Kingdom.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Royaume-Uni</country>
<wicri:regionArea> Hepatic-Pancreatico-Biliary Surgical Services and Edinburgh Transplant Unit, Royal Infirmary of Edinburgh, Edinburgh, Scotland</wicri:regionArea>
<wicri:noRegion>Scotland</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Hidalgo, Ernest" sort="Hidalgo, Ernest" uniqKey="Hidalgo E" first="Ernest" last="Hidalgo">Ernest Hidalgo</name>
<affiliation wicri:level="1"><nlm:aff id="aff17"> Hepatic-Pancreatico-Biliary Surgical Services and Edinburgh Transplant Unit, Royal Infirmary of Edinburgh, Edinburgh, Scotland, United Kingdom.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Royaume-Uni</country>
<wicri:regionArea> Hepatic-Pancreatico-Biliary Surgical Services and Edinburgh Transplant Unit, Royal Infirmary of Edinburgh, Edinburgh, Scotland</wicri:regionArea>
<wicri:noRegion>Scotland</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Gugenheim, Jean" sort="Gugenheim, Jean" uniqKey="Gugenheim J" first="Jean" last="Gugenheim">Jean Gugenheim</name>
<affiliation wicri:level="3"><nlm:aff id="aff18"> Service de Chirurgie Digestive, Centre de Transplantation Hépatique, Hôpital ARCHET 2, Centre Hospitalier Universitaire de Nice, Nice, France.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">France</country>
<wicri:regionArea> Service de Chirurgie Digestive, Centre de Transplantation Hépatique, Hôpital ARCHET 2, Centre Hospitalier Universitaire de Nice, Nice</wicri:regionArea>
<placeName><region type="region">Provence-Alpes-Côte d'Azur</region>
<region type="old region">Provence-Alpes-Côte d'Azur</region>
<settlement type="city">Nice</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Wolters, Heiner" sort="Wolters, Heiner" uniqKey="Wolters H" first="Heiner" last="Wolters">Heiner Wolters</name>
<affiliation wicri:level="3"><nlm:aff id="aff19"> Klinik für Allgemein- und Viszeralchirurgie, Universitätsklinikum Münster, Münster, Germany.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Allemagne</country>
<wicri:regionArea> Klinik für Allgemein- und Viszeralchirurgie, Universitätsklinikum Münster, Münster</wicri:regionArea>
<placeName><region type="land" nuts="1">Rhénanie-du-Nord-Westphalie</region>
<region type="district" nuts="2">District de Münster</region>
<settlement type="city">Münster</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Brockmann, Jens" sort="Brockmann, Jens" uniqKey="Brockmann J" first="Jens" last="Brockmann">Jens Brockmann</name>
<affiliation wicri:level="3"><nlm:aff id="aff19"> Klinik für Allgemein- und Viszeralchirurgie, Universitätsklinikum Münster, Münster, Germany.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Allemagne</country>
<wicri:regionArea> Klinik für Allgemein- und Viszeralchirurgie, Universitätsklinikum Münster, Münster</wicri:regionArea>
<placeName><region type="land" nuts="1">Rhénanie-du-Nord-Westphalie</region>
<region type="district" nuts="2">District de Münster</region>
<settlement type="city">Münster</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Roy, Andre" sort="Roy, Andre" uniqKey="Roy A" first="André" last="Roy">André Roy</name>
<affiliation wicri:level="1"><nlm:aff id="aff20"> Hepatobiliary and Pancreatic Surgery Unit, Hopital St Luc, Centre Hospitalier de l'Université Montréal (CHUM), Principal Pavillion, Montreal, Quebec, Canada.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Canada</country>
<wicri:regionArea> Hepatobiliary and Pancreatic Surgery Unit, Hopital St Luc, Centre Hospitalier de l'Université Montréal (CHUM), Principal Pavillion, Montreal, Quebec</wicri:regionArea>
<wicri:noRegion>Quebec</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Mutzbauer, Ingrid" sort="Mutzbauer, Ingrid" uniqKey="Mutzbauer I" first="Ingrid" last="Mutzbauer">Ingrid Mutzbauer</name>
<affiliation wicri:level="1"><nlm:aff id="aff1"> Department of Surgery and Section of Experimental Surgery, University Hospital Regensburg, Regensburg, Germany.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Allemagne</country>
<wicri:regionArea> Department of Surgery and Section of Experimental Surgery, University Hospital Regensburg, Regensburg</wicri:regionArea>
<wicri:noRegion>Regensburg</wicri:noRegion>
<wicri:noRegion>Regensburg</wicri:noRegion>
<wicri:noRegion>Regensburg</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Schlitt, Angela" sort="Schlitt, Angela" uniqKey="Schlitt A" first="Angela" last="Schlitt">Angela Schlitt</name>
<affiliation wicri:level="1"><nlm:aff id="aff1"> Department of Surgery and Section of Experimental Surgery, University Hospital Regensburg, Regensburg, Germany.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Allemagne</country>
<wicri:regionArea> Department of Surgery and Section of Experimental Surgery, University Hospital Regensburg, Regensburg</wicri:regionArea>
<wicri:noRegion>Regensburg</wicri:noRegion>
<wicri:noRegion>Regensburg</wicri:noRegion>
<wicri:noRegion>Regensburg</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Beckebaum, Susanne" sort="Beckebaum, Susanne" uniqKey="Beckebaum S" first="Susanne" last="Beckebaum">Susanne Beckebaum</name>
<affiliation wicri:level="1"><nlm:aff id="aff21"> Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Universitätsklinikum Essen, Essen, Germany.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Allemagne</country>
<wicri:regionArea> Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Universitätsklinikum Essen, Essen</wicri:regionArea>
<wicri:noRegion>Essen</wicri:noRegion>
<wicri:noRegion>Essen</wicri:noRegion>
<wicri:noRegion>Essen</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Graeb, Christian" sort="Graeb, Christian" uniqKey="Graeb C" first="Christian" last="Graeb">Christian Graeb</name>
<affiliation wicri:level="3"><nlm:aff id="aff5"> Klinik für Allgemeine, Viszeral, Transplantations- Gefäß- und Thoraxchirurgie, Klinikum der Ludwig-Maximilians-Universität München-Großhadern, München, Germany.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Allemagne</country>
<wicri:regionArea> Klinik für Allgemeine, Viszeral, Transplantations- Gefäß- und Thoraxchirurgie, Klinikum der Ludwig-Maximilians-Universität München-Großhadern, München</wicri:regionArea>
<placeName><region type="land" nuts="1">Bavière</region>
<region type="district" nuts="2">District de Haute-Bavière</region>
<settlement type="city">Munich</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Nadalin, Silvio" sort="Nadalin, Silvio" uniqKey="Nadalin S" first="Silvio" last="Nadalin">Silvio Nadalin</name>
<affiliation wicri:level="3"><nlm:aff id="aff22"> Klinik für Allgemeine, Viszeral- und Transplantationschirurgie, Klinikum der Universität Tübingen, Tübingen, Germany.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Allemagne</country>
<wicri:regionArea> Klinik für Allgemeine, Viszeral- und Transplantationschirurgie, Klinikum der Universität Tübingen, Tübingen</wicri:regionArea>
<placeName><region type="land" nuts="1">Bade-Wurtemberg</region>
<region type="district" nuts="2">District de Tübingen</region>
<settlement type="city">Tübingen</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Valente, Umberto" sort="Valente, Umberto" uniqKey="Valente U" first="Umberto" last="Valente">Umberto Valente</name>
<affiliation wicri:level="1"><nlm:aff id="aff23"> Chirurgia Generale e Trapianti d'Organo, Università di Genova-Azienda Ospedaliera Universitaria San Martino di Genova, Genova, Italy.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Italie</country>
<wicri:regionArea> Chirurgia Generale e Trapianti d'Organo, Università di Genova-Azienda Ospedaliera Universitaria San Martino di Genova, Genova</wicri:regionArea>
<wicri:noRegion>Genova</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Turri N, Victor Sanchez" sort="Turri N, Victor Sanchez" uniqKey="Turri N V" first="Victor Sánchez" last="Turri N">Victor Sánchez Turri N</name>
<affiliation wicri:level="3"><nlm:aff id="aff24"> Unidad de Trasplante Hepático, Departamento de Cirugía, Hospital Universitario Puerta de Hierro-Majadahonda, Madrid, Spain.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Espagne</country>
<wicri:regionArea> Unidad de Trasplante Hepático, Departamento de Cirugía, Hospital Universitario Puerta de Hierro-Majadahonda, Madrid</wicri:regionArea>
<placeName><settlement type="city">Madrid</settlement>
<region nuts="2" type="region">Communauté de Madrid</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Jamieson, Neville" sort="Jamieson, Neville" uniqKey="Jamieson N" first="Neville" last="Jamieson">Neville Jamieson</name>
<affiliation wicri:level="1"><nlm:aff id="aff25"> Department of Surgery, NHS Foundation Trust, Addenbrooke's Hospital, Cambridge University Hospitals, Cambridge, United Kingdom.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Royaume-Uni</country>
<wicri:regionArea> Department of Surgery, NHS Foundation Trust, Addenbrooke's Hospital, Cambridge University Hospitals, Cambridge</wicri:regionArea>
<wicri:noRegion>Cambridge</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Scholz, Tim" sort="Scholz, Tim" uniqKey="Scholz T" first="Tim" last="Scholz">Tim Scholz</name>
<affiliation wicri:level="3"><nlm:aff id="aff26"> Section for Transplant Surgery, Clinic for Cancer, Surgery and Transplantation, Department of Transplantation Medicine, Oslo University Hospital, Rikshospitalet, Oslo, Norway.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Norvège</country>
<wicri:regionArea> Section for Transplant Surgery, Clinic for Cancer, Surgery and Transplantation, Department of Transplantation Medicine, Oslo University Hospital, Rikshospitalet, Oslo</wicri:regionArea>
<placeName><settlement type="city">Oslo</settlement>
<region nuts="2">Østlandet</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Colledan, Michele" sort="Colledan, Michele" uniqKey="Colledan M" first="Michele" last="Colledan">Michele Colledan</name>
<affiliation wicri:level="1"><nlm:aff id="aff27"> Chirurgia terza e Chirurgia Toracica, Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, Italy.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Italie</country>
<wicri:regionArea> Chirurgia terza e Chirurgia Toracica, Azienda Ospedaliera Papa Giovanni XXIII, Bergamo</wicri:regionArea>
<wicri:noRegion>Bergamo</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="F Ndrich, Fred" sort="F Ndrich, Fred" uniqKey="F Ndrich F" first="Fred" last="F Ndrich">Fred F Ndrich</name>
<affiliation wicri:level="3"><nlm:aff id="aff28"> Klinik für Allgemeine Chirurgie, Viszeral-, Thorax, Transplantations- und Kinderchirurgie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel, Germany.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Allemagne</country>
<wicri:regionArea> Klinik für Allgemeine Chirurgie, Viszeral-, Thorax, Transplantations- und Kinderchirurgie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel</wicri:regionArea>
<placeName><region type="land" nuts="2">Schleswig-Holstein</region>
<settlement type="city">Kiel</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Becker, Thomas" sort="Becker, Thomas" uniqKey="Becker T" first="Thomas" last="Becker">Thomas Becker</name>
<affiliation wicri:level="3"><nlm:aff id="aff28"> Klinik für Allgemeine Chirurgie, Viszeral-, Thorax, Transplantations- und Kinderchirurgie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel, Germany.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Allemagne</country>
<wicri:regionArea> Klinik für Allgemeine Chirurgie, Viszeral-, Thorax, Transplantations- und Kinderchirurgie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel</wicri:regionArea>
<placeName><region type="land" nuts="2">Schleswig-Holstein</region>
<settlement type="city">Kiel</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Soderdahl, Gunnar" sort="Soderdahl, Gunnar" uniqKey="Soderdahl G" first="Gunnar" last="Söderdahl">Gunnar Söderdahl</name>
<affiliation wicri:level="3"><nlm:aff id="aff29"> Department of Transplantation Surgery, Karolinska University Hospital, Stockholm, Sweden.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Suède</country>
<wicri:regionArea> Department of Transplantation Surgery, Karolinska University Hospital, Stockholm</wicri:regionArea>
<placeName><settlement type="city">Stockholm</settlement>
<region nuts="2">Svealand</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Chazouilleres, Olivier" sort="Chazouilleres, Olivier" uniqKey="Chazouilleres O" first="Olivier" last="Chazouillères">Olivier Chazouillères</name>
<affiliation wicri:level="3"><nlm:aff id="aff30"> Federation d'Hepato-Gastro-Enterologie, Service d'Hepatologie, Hôpital Saint Antoine, Paris, France.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">France</country>
<wicri:regionArea> Federation d'Hepato-Gastro-Enterologie, Service d'Hepatologie, Hôpital Saint Antoine, Paris</wicri:regionArea>
<placeName><region type="region">Île-de-France</region>
<region type="old region">Île-de-France</region>
<settlement type="city">Paris</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="M Kisalo, Heikki" sort="M Kisalo, Heikki" uniqKey="M Kisalo H" first="Heikki" last="M Kisalo">Heikki M Kisalo</name>
<affiliation wicri:level="1"><nlm:aff id="aff31"> Division of Transplantation and Liver Surgery, Helsinki University Central Hospital, Helsinki, Finland.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Finlande</country>
<wicri:regionArea> Division of Transplantation and Liver Surgery, Helsinki University Central Hospital, Helsinki</wicri:regionArea>
<wicri:noRegion>Helsinki</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Pageaux, Georges Philippe" sort="Pageaux, Georges Philippe" uniqKey="Pageaux G" first="Georges-Philippe" last="Pageaux">Georges-Philippe Pageaux</name>
<affiliation wicri:level="3"><nlm:aff id="aff32"> Service d'Hepato-Gastroentérologie et Transplantation Hepatique, CHRU de Montpellier, APEMAD, Hôpital Saint-Eloi, Montpellier, France.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">France</country>
<wicri:regionArea> Service d'Hepato-Gastroentérologie et Transplantation Hepatique, CHRU de Montpellier, APEMAD, Hôpital Saint-Eloi, Montpellier</wicri:regionArea>
<placeName><region type="region">Occitanie (région administrative)</region>
<region type="old region">Languedoc-Roussillon</region>
<settlement type="city">Montpellier</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Steininger, Rudolf" sort="Steininger, Rudolf" uniqKey="Steininger R" first="Rudolf" last="Steininger">Rudolf Steininger</name>
<affiliation wicri:level="3"><nlm:aff id="aff33"> Abteilung für Transplantation, Universitätsklinik für Chirurgie, Medizinische Universität Wien, AKH-Wien, Vienna, Austria.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Autriche</country>
<wicri:regionArea> Abteilung für Transplantation, Universitätsklinik für Chirurgie, Medizinische Universität Wien, AKH-Wien, Vienna</wicri:regionArea>
<placeName><settlement type="city">Vienne (Autriche)</settlement>
<region nuts="2" type="province">Vienne (Autriche)</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Soliman, Thomas" sort="Soliman, Thomas" uniqKey="Soliman T" first="Thomas" last="Soliman">Thomas Soliman</name>
<affiliation wicri:level="3"><nlm:aff id="aff33"> Abteilung für Transplantation, Universitätsklinik für Chirurgie, Medizinische Universität Wien, AKH-Wien, Vienna, Austria.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Autriche</country>
<wicri:regionArea> Abteilung für Transplantation, Universitätsklinik für Chirurgie, Medizinische Universität Wien, AKH-Wien, Vienna</wicri:regionArea>
<placeName><settlement type="city">Vienne (Autriche)</settlement>
<region nuts="2" type="province">Vienne (Autriche)</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="De Jong, Koert P" sort="De Jong, Koert P" uniqKey="De Jong K" first="Koert P." last="De Jong">Koert P. De Jong</name>
<affiliation wicri:level="3"><nlm:aff id="aff34"> Division of Hepato-Pancreatico-Biliary Surgery and Liver Transplantation, Department of Surgery, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Pays-Bas</country>
<wicri:regionArea> Division of Hepato-Pancreatico-Biliary Surgery and Liver Transplantation, Department of Surgery, University Medical Center Groningen, University of Groningen, Groningen</wicri:regionArea>
<placeName><settlement type="city">Groningue</settlement>
<region nuts="2" type="province">Groningue (province)</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Pirenne, Jacques" sort="Pirenne, Jacques" uniqKey="Pirenne J" first="Jacques" last="Pirenne">Jacques Pirenne</name>
<affiliation wicri:level="1"><nlm:aff id="aff35"> Abdominale Transplantatiechirurgie, UZ Leuven, Campus Gasthuisberg, Leuven, Belgium.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Belgique</country>
<wicri:regionArea> Abdominale Transplantatiechirurgie, UZ Leuven, Campus Gasthuisberg, Leuven</wicri:regionArea>
<wicri:noRegion>Leuven</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Margreiter, Raimund" sort="Margreiter, Raimund" uniqKey="Margreiter R" first="Raimund" last="Margreiter">Raimund Margreiter</name>
<affiliation wicri:level="1"><nlm:aff id="aff36"> Universitätsklinik für Visceral-, Transplantations-Throaxchirurgie, Medizinische Universität Innsbruck, Innsbruck, Austria.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Autriche</country>
<wicri:regionArea> Universitätsklinik für Visceral-, Transplantations-Throaxchirurgie, Medizinische Universität Innsbruck, Innsbruck</wicri:regionArea>
<wicri:noRegion>Innsbruck</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Pratschke, Johann" sort="Pratschke, Johann" uniqKey="Pratschke J" first="Johann" last="Pratschke">Johann Pratschke</name>
<affiliation wicri:level="1"><nlm:aff id="aff36"> Universitätsklinik für Visceral-, Transplantations-Throaxchirurgie, Medizinische Universität Innsbruck, Innsbruck, Austria.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Autriche</country>
<wicri:regionArea> Universitätsklinik für Visceral-, Transplantations-Throaxchirurgie, Medizinische Universität Innsbruck, Innsbruck</wicri:regionArea>
<wicri:noRegion>Innsbruck</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Pinna, Antonio D" sort="Pinna, Antonio D" uniqKey="Pinna A" first="Antonio D." last="Pinna">Antonio D. Pinna</name>
<affiliation wicri:level="4"><nlm:aff id="aff37"> Chirurgia Generale e dei Trapianti, Policlinico S. Orsola-Malpighi, Universita di Bologna, Bologna, Italy.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Italie</country>
<wicri:regionArea> Chirurgia Generale e dei Trapianti, Policlinico S. Orsola-Malpighi, Universita di Bologna, Bologna</wicri:regionArea>
<orgName type="university">Université de Bologne</orgName>
<placeName><settlement type="city">Bologne</settlement>
<region nuts="2" type="region">Émilie-Romagne</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Hauss, Johann" sort="Hauss, Johann" uniqKey="Hauss J" first="Johann" last="Hauss">Johann Hauss</name>
<affiliation wicri:level="3"><nlm:aff id="aff38"> Klinik für Visceral-, Transplantations-, Thorax- und Gefäßchirurgie, Universitätsklinikum Leipzig, Leipzig, Germany.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Allemagne</country>
<wicri:regionArea> Klinik für Visceral-, Transplantations-, Thorax- und Gefäßchirurgie, Universitätsklinikum Leipzig, Leipzig</wicri:regionArea>
<placeName><region type="land" nuts="1">Saxe (Land)</region>
<region type="district" nuts="2">District de Leipzig</region>
<settlement type="city">Leipzig</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Schreiber, Stefan" sort="Schreiber, Stefan" uniqKey="Schreiber S" first="Stefan" last="Schreiber">Stefan Schreiber</name>
<affiliation wicri:level="3"><nlm:aff id="aff38"> Klinik für Visceral-, Transplantations-, Thorax- und Gefäßchirurgie, Universitätsklinikum Leipzig, Leipzig, Germany.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Allemagne</country>
<wicri:regionArea> Klinik für Visceral-, Transplantations-, Thorax- und Gefäßchirurgie, Universitätsklinikum Leipzig, Leipzig</wicri:regionArea>
<placeName><region type="land" nuts="1">Saxe (Land)</region>
<region type="district" nuts="2">District de Leipzig</region>
<settlement type="city">Leipzig</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Strasser, Simone" sort="Strasser, Simone" uniqKey="Strasser S" first="Simone" last="Strasser">Simone Strasser</name>
<affiliation wicri:level="1"><nlm:aff id="aff39"> AW Morrow Gastroenterology and Liver Centre and Liver Transplant Unit, Royal Prince Alfred Hospital, Sydney, NSW, Australia.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Australie</country>
<wicri:regionArea> AW Morrow Gastroenterology and Liver Centre and Liver Transplant Unit, Royal Prince Alfred Hospital, Sydney, NSW</wicri:regionArea>
<wicri:noRegion>NSW</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Klempnauer, Jurgen" sort="Klempnauer, Jurgen" uniqKey="Klempnauer J" first="Jürgen" last="Klempnauer">Jürgen Klempnauer</name>
<affiliation wicri:level="3"><nlm:aff id="aff40"> Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Medizinische Hochschule Hannover, Hannover, Germany.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Allemagne</country>
<wicri:regionArea> Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Medizinische Hochschule Hannover, Hannover</wicri:regionArea>
<placeName><region type="land" nuts="2">Basse-Saxe</region>
<settlement type="city">Hanovre</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Troisi, Roberto I" sort="Troisi, Roberto I" uniqKey="Troisi R" first="Roberto I." last="Troisi">Roberto I. Troisi</name>
<affiliation wicri:level="1"><nlm:aff id="aff41"> Hepato-Biliary and Pancreatic Surgery, Ghent University Hospital and Medical School, Ghent, Belgium.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Belgique</country>
<wicri:regionArea> Hepato-Biliary and Pancreatic Surgery, Ghent University Hospital and Medical School, Ghent</wicri:regionArea>
<wicri:noRegion>Ghent</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Bhoori, Sherrie" sort="Bhoori, Sherrie" uniqKey="Bhoori S" first="Sherrie" last="Bhoori">Sherrie Bhoori</name>
<affiliation wicri:level="3"><nlm:aff id="aff42"> Department of Surgery, Transplantation and Hepatobiliary Cancer Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, National Cancer Institute Milan, Milan, Italy.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Italie</country>
<wicri:regionArea> Department of Surgery, Transplantation and Hepatobiliary Cancer Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, National Cancer Institute Milan, Milan</wicri:regionArea>
<placeName><settlement type="city">Milan</settlement>
<region nuts="2">Lombardie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Lerut, Jan" sort="Lerut, Jan" uniqKey="Lerut J" first="Jan" last="Lerut">Jan Lerut</name>
<affiliation wicri:level="3"><nlm:aff id="aff43"> Department of Abdominal and Transplantation Surgery (SCTA), UCL Transplant Centre, University Hospitals Saint-Luc, Brussels, Belgium.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Belgique</country>
<wicri:regionArea> Department of Abdominal and Transplantation Surgery (SCTA), UCL Transplant Centre, University Hospitals Saint-Luc, Brussels</wicri:regionArea>
<placeName><settlement type="city">Bruxelles</settlement>
<region nuts="2">Région de Bruxelles-Capitale</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Bilbao, Itxarone" sort="Bilbao, Itxarone" uniqKey="Bilbao I" first="Itxarone" last="Bilbao">Itxarone Bilbao</name>
<affiliation wicri:level="3"><nlm:aff id="aff44"> Servicio de Cirugía General, Unidad de Trasplante Hepatico, Hospital Universitari Vall d'Hebron, Barcelona, Spain.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Espagne</country>
<wicri:regionArea> Servicio de Cirugía General, Unidad de Trasplante Hepatico, Hospital Universitari Vall d'Hebron, Barcelona</wicri:regionArea>
<placeName><settlement type="city">Barcelone</settlement>
<region nuts="2" type="region">Catalogne</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Klein, Christian G" sort="Klein, Christian G" uniqKey="Klein C" first="Christian G." last="Klein">Christian G. Klein</name>
<affiliation wicri:level="1"><nlm:aff id="aff21"> Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Universitätsklinikum Essen, Essen, Germany.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Allemagne</country>
<wicri:regionArea> Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Universitätsklinikum Essen, Essen</wicri:regionArea>
<wicri:noRegion>Essen</wicri:noRegion>
<wicri:noRegion>Essen</wicri:noRegion>
<wicri:noRegion>Essen</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Konigsrainer, Alfred" sort="Konigsrainer, Alfred" uniqKey="Konigsrainer A" first="Alfred" last="Königsrainer">Alfred Königsrainer</name>
<affiliation wicri:level="3"><nlm:aff id="aff22"> Klinik für Allgemeine, Viszeral- und Transplantationschirurgie, Klinikum der Universität Tübingen, Tübingen, Germany.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Allemagne</country>
<wicri:regionArea> Klinik für Allgemeine, Viszeral- und Transplantationschirurgie, Klinikum der Universität Tübingen, Tübingen</wicri:regionArea>
<placeName><region type="land" nuts="1">Bade-Wurtemberg</region>
<region type="district" nuts="2">District de Tübingen</region>
<settlement type="city">Tübingen</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Mirza, Darius F" sort="Mirza, Darius F" uniqKey="Mirza D" first="Darius F." last="Mirza">Darius F. Mirza</name>
<affiliation wicri:level="3"><nlm:aff id="aff45"> The Queen Elizabeth Hospital, Liver and Hepato-Pancreato-Biliary (HPB) Unit, NHS Foundation Trust, University Hospitals Birmingham, Edgbaston, Birmingham, United Kingdom.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Royaume-Uni</country>
<wicri:regionArea> The Queen Elizabeth Hospital, Liver and Hepato-Pancreato-Biliary (HPB) Unit, NHS Foundation Trust, University Hospitals Birmingham, Edgbaston, Birmingham</wicri:regionArea>
<placeName><settlement type="city">Birmingham</settlement>
<region type="country">Angleterre</region>
<region type="région" nuts="1">Midlands de l'Ouest</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Otto, Gerd" sort="Otto, Gerd" uniqKey="Otto G" first="Gerd" last="Otto">Gerd Otto</name>
<affiliation wicri:level="3"><nlm:aff id="aff8"> Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Mainz, Germany.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Allemagne</country>
<wicri:regionArea> Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Mainz</wicri:regionArea>
<placeName><region type="land" nuts="2">Rhénanie-Palatinat</region>
<settlement type="city">Mayence</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Mazzaferro, Vincenzo" sort="Mazzaferro, Vincenzo" uniqKey="Mazzaferro V" first="Vincenzo" last="Mazzaferro">Vincenzo Mazzaferro</name>
<affiliation wicri:level="3"><nlm:aff id="aff42"> Department of Surgery, Transplantation and Hepatobiliary Cancer Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, National Cancer Institute Milan, Milan, Italy.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Italie</country>
<wicri:regionArea> Department of Surgery, Transplantation and Hepatobiliary Cancer Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, National Cancer Institute Milan, Milan</wicri:regionArea>
<placeName><settlement type="city">Milan</settlement>
<region nuts="2">Lombardie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Neuhaus, Peter" sort="Neuhaus, Peter" uniqKey="Neuhaus P" first="Peter" last="Neuhaus">Peter Neuhaus</name>
<affiliation wicri:level="3"><nlm:aff id="aff46"> Klinik für Allgemein-, Visceral- und Transplantationschirurgie, Charité Campus Virchow Klinikum, Universitätsmedizin Berlin, Berlin, Germany.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Allemagne</country>
<wicri:regionArea> Klinik für Allgemein-, Visceral- und Transplantationschirurgie, Charité Campus Virchow Klinikum, Universitätsmedizin Berlin, Berlin</wicri:regionArea>
<placeName><region type="land" nuts="3">Berlin</region>
<settlement type="city">Berlin</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Schlitt, Hans J" sort="Schlitt, Hans J" uniqKey="Schlitt H" first="Hans J." last="Schlitt">Hans J. Schlitt</name>
<affiliation wicri:level="1"><nlm:aff id="aff1"> Department of Surgery and Section of Experimental Surgery, University Hospital Regensburg, Regensburg, Germany.</nlm:aff>
<country xml:lang="fr" wicri:curation="lc">Allemagne</country>
<wicri:regionArea> Department of Surgery and Section of Experimental Surgery, University Hospital Regensburg, Regensburg</wicri:regionArea>
<wicri:noRegion>Regensburg</wicri:noRegion>
<wicri:noRegion>Regensburg</wicri:noRegion>
<wicri:noRegion>Regensburg</wicri:noRegion>
</affiliation>
</author>
</analytic>
<series><title level="j">Transplantation</title>
<idno type="ISSN">0041-1337</idno>
<idno type="eISSN">1534-6080</idno>
<imprint><date when="2015">2015</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
</fileDesc>
<profileDesc><textClass></textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en"><title>Background</title>
<p>We investigated whether sirolimus-based immunosuppression improves outcomes in liver transplantation (LTx) candidates with hepatocellular carcinoma (HCC).</p>
<sec><title>Methods</title>
<p>In a prospective-randomized open-label international trial, 525 LTx recipients with HCC initially receiving mammalian target of rapamycin inhibitor–free immunosuppression were randomized 4 to 6 weeks after transplantation into a group on mammalian target of rapamycin inhibitor–free immunosuppression (group A: 264 patients) or a group incorporating sirolimus (group B: 261). The primary endpoint was recurrence-free survival (RFS); intention-to-treat (ITT) analysis was conducted after 8 years. Overall survival (OS) was a secondary endpoint.</p>
</sec>
<sec><title>Results</title>
<p>Recurrence-free survival was 64.5% in group A and 70.2% in group B at study end, this difference was not significant (<italic>P</italic>
= 0.28; hazard ratio [HR], 0.84; 95% confidence interval [95% CI], 0.62; 1.15). In a planned analysis of RFS rates at yearly intervals, group B showed better outcomes 3 years after transplantation (HR, 0.7; 95% CI, 0.48-1.00). Similarly, OS (<italic>P</italic>
= 0.21; HR, 0.81; 95% CI, 0.58-1.13) was not statistically better in group B at study end, but yearly analyses showed improvement out to 5 years (HR, 0.7; 95% CI, 0.49-1.00). Interestingly, subgroup (Milan Criteria-based) analyses revealed that low-risk, rather than high-risk, patients benefited most from sirolimus; furthermore, younger recipients (age ≤60) also benefited, as well sirolimus monotherapy patients. Serious adverse event numbers were alike in groups A (860) and B (874).</p>
</sec>
<sec><title>Conclusions</title>
<p>Sirolimus in LTx recipients with HCC does not improve long-term RFS beyond 5 years. However, a RFS and OS benefit is evident in the first 3 to 5 years, especially in low-risk patients. This trial provides the first high-level evidence base for selecting immunosuppression in LTx recipients with HCC.</p>
</sec>
</div>
</front>
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</TEI>
<pmc article-type="research-article"><pmc-dir>properties open_access</pmc-dir>
<front><journal-meta><journal-id journal-id-type="nlm-ta">Transplantation</journal-id>
<journal-id journal-id-type="iso-abbrev">Transplantation</journal-id>
<journal-id journal-id-type="publisher-id">TP</journal-id>
<journal-title-group><journal-title>Transplantation</journal-title>
</journal-title-group>
<issn pub-type="ppub">0041-1337</issn>
<issn pub-type="epub">1534-6080</issn>
<publisher><publisher-name>Lippincott Williams & Wilkins</publisher-name>
</publisher>
</journal-meta>
<article-meta><article-id pub-id-type="pmid">26555945</article-id>
<article-id pub-id-type="pmc">4683033</article-id>
<article-id pub-id-type="publisher-id">TP500246</article-id>
<article-id pub-id-type="doi">10.1097/TP.0000000000000965</article-id>
<article-id pub-id-type="art-access-id">00020</article-id>
<article-categories><subj-group subj-group-type="heading"><subject>Original Clinical Science—Liver</subject>
</subj-group>
</article-categories>
<title-group><article-title>Sirolimus Use in Liver Transplant Recipients With Hepatocellular Carcinoma: A Randomized, Multicenter, Open-Label Phase 3 Trial</article-title>
</title-group>
<contrib-group><contrib contrib-type="author"><name><surname>Geissler</surname>
<given-names>Edward K.</given-names>
</name>
<degrees>PhD</degrees>
<xref ref-type="aff" rid="aff1"><sup>1</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Schnitzbauer</surname>
<given-names>Andreas A.</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="aff1"><sup>1</sup>
</xref>
<xref ref-type="aff" rid="aff2"><sup>2</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Zülke</surname>
<given-names>Carl</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="aff1"><sup>1</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Lamby</surname>
<given-names>Philipp E.</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="aff1"><sup>1</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Proneth</surname>
<given-names>Andrea</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="aff1"><sup>1</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Duvoux</surname>
<given-names>Christophe</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="aff3"><sup>3</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Burra</surname>
<given-names>Patrizia</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="aff4"><sup>4</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Jauch</surname>
<given-names>Karl-Walter</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="aff5"><sup>5</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Rentsch</surname>
<given-names>Markus</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="aff5"><sup>5</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Ganten</surname>
<given-names>Tom M.</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="aff6"><sup>6</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Schmidt</surname>
<given-names>Jan</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="aff6"><sup>6</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Settmacher</surname>
<given-names>Utz</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="aff7"><sup>7</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Heise</surname>
<given-names>Michael</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="aff7 aff8"><sup>7,8</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Rossi</surname>
<given-names>Giorgio</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="aff9"><sup>9</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Cillo</surname>
<given-names>Umberto</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="aff10"><sup>10</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Kneteman</surname>
<given-names>Norman</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="aff11"><sup>11</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Adam</surname>
<given-names>René</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="aff12"><sup>12</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>van Hoek</surname>
<given-names>Bart</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="aff13"><sup>13</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Bachellier</surname>
<given-names>Philippe</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="aff14"><sup>14</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Wolf</surname>
<given-names>Philippe</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="aff14"><sup>14</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Rostaing</surname>
<given-names>Lionel</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="aff15"><sup>15</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Bechstein</surname>
<given-names>Wolf O.</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="aff2"><sup>2</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Rizell</surname>
<given-names>Magnus</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="aff16"><sup>16</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Powell</surname>
<given-names>James</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="aff17"><sup>17</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Hidalgo</surname>
<given-names>Ernest</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="aff17"><sup>17</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Gugenheim</surname>
<given-names>Jean</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="aff18"><sup>18</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Wolters</surname>
<given-names>Heiner</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="aff19"><sup>19</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Brockmann</surname>
<given-names>Jens</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="aff19"><sup>19</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Roy</surname>
<given-names>André</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="aff20"><sup>20</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Mutzbauer</surname>
<given-names>Ingrid</given-names>
</name>
<xref ref-type="aff" rid="aff1"><sup>1</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Schlitt</surname>
<given-names>Angela</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="aff1"><sup>1</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Beckebaum</surname>
<given-names>Susanne</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="aff21"><sup>21</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Graeb</surname>
<given-names>Christian</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="aff5"><sup>5</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Nadalin</surname>
<given-names>Silvio</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="aff22"><sup>22</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Valente</surname>
<given-names>Umberto</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="aff23"><sup>23</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Turrión</surname>
<given-names>Victor Sánchez</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="aff24"><sup>24</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Jamieson</surname>
<given-names>Neville</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="aff25"><sup>25</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Scholz</surname>
<given-names>Tim</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="aff26"><sup>26</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Colledan</surname>
<given-names>Michele</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="aff27"><sup>27</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Fändrich</surname>
<given-names>Fred</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="aff28"><sup>28</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Becker</surname>
<given-names>Thomas</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="aff28"><sup>28</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Söderdahl</surname>
<given-names>Gunnar</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="aff29"><sup>29</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Chazouillères</surname>
<given-names>Olivier</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="aff30"><sup>30</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Mäkisalo</surname>
<given-names>Heikki</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="aff31"><sup>31</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Pageaux</surname>
<given-names>Georges-Philippe</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="aff32"><sup>32</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Steininger</surname>
<given-names>Rudolf</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="aff33"><sup>33</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Soliman</surname>
<given-names>Thomas</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="aff33"><sup>33</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>de Jong</surname>
<given-names>Koert P.</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="aff34"><sup>34</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Pirenne</surname>
<given-names>Jacques</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="aff35"><sup>35</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Margreiter</surname>
<given-names>Raimund</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="aff36"><sup>36</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Pratschke</surname>
<given-names>Johann</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="aff36"><sup>36</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Pinna</surname>
<given-names>Antonio D.</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="aff37"><sup>37</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Hauss</surname>
<given-names>Johann</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="aff38"><sup>38</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Schreiber</surname>
<given-names>Stefan</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="aff38"><sup>38</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Strasser</surname>
<given-names>Simone</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="aff39"><sup>39</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Klempnauer</surname>
<given-names>Jürgen</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="aff40"><sup>40</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Troisi</surname>
<given-names>Roberto I.</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="aff41"><sup>41</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Bhoori</surname>
<given-names>Sherrie</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="aff42"><sup>42</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Lerut</surname>
<given-names>Jan</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="aff43"><sup>43</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Bilbao</surname>
<given-names>Itxarone</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="aff44"><sup>44</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Klein</surname>
<given-names>Christian G.</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="aff21"><sup>21</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Königsrainer</surname>
<given-names>Alfred</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="aff22"><sup>22</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Mirza</surname>
<given-names>Darius F.</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="aff45"><sup>45</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Otto</surname>
<given-names>Gerd</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="aff8"><sup>8</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Mazzaferro</surname>
<given-names>Vincenzo</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="aff42"><sup>42</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Neuhaus</surname>
<given-names>Peter</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="aff46"><sup>46</sup>
</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Schlitt</surname>
<given-names>Hans J.</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="aff1"><sup>1</sup>
</xref>
</contrib>
</contrib-group>
<aff id="aff1"><sup>1</sup>
Department of Surgery and Section of Experimental Surgery, University Hospital Regensburg, Regensburg, Germany.</aff>
<aff id="aff2"><sup>2</sup>
Klinik für Allgemein- und Viszeralchirurgie, Universitätsklinikum Frankfurt, Frankfurt am Main, Germany.</aff>
<aff id="aff3"><sup>3</sup>
Unite d‘Hepatologie et de Transplantation Hepatique, Centre Hospitalier Universitaire Henri-Mondor, Service d'Hepatologie et de Gastroenterologie, Université Paris-Est Créteil Val-de-Marne, Paris, France.</aff>
<aff id="aff4"><sup>4</sup>
Dipartimento di Scienze Chirurgiche, Oncologiche e Gastroenterologiche (DiSCOG), Università degli Studi di Padova, Padova, Italy.</aff>
<aff id="aff5"><sup>5</sup>
Klinik für Allgemeine, Viszeral, Transplantations- Gefäß- und Thoraxchirurgie, Klinikum der Ludwig-Maximilians-Universität München-Großhadern, München, Germany.</aff>
<aff id="aff6"><sup>6</sup>
Innere Medizin IV, Sektion Lebertransplantation, Universitätsklinikum Heidelberg, Heidelberg, Germany.</aff>
<aff id="aff7"><sup>7</sup>
Klinik für Allgemein-, Viszeral- und Gefässchirurgie, Universitätsklinikum Jena, Jena, Germany.</aff>
<aff id="aff8"><sup>8</sup>
Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Mainz, Germany.</aff>
<aff id="aff9"><sup>9</sup>
Centro Trapianti Fegato, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico IRCCS di Milano, Milan, Italy.</aff>
<aff id="aff10"><sup>10</sup>
Chirurgia Epatobiliare e Trapianto Epatico, Azienda Ospedaliera di Padova, Università di Padova, Padova, Italy.</aff>
<aff id="aff11"><sup>11</sup>
Alberta Health Services Liver Transplant Program, University of Alberta, Edmonton, Alberta, Canada.</aff>
<aff id="aff12"><sup>12</sup>
Centre Hépato Biliaire, Hôpital Paul Brousse, Villejuif Cedex, Paris, France.</aff>
<aff id="aff13"><sup>13</sup>
Department of Gastroenterology and Hepatology, Leiden University Medical Center (LUMC), Leiden, Netherlands.</aff>
<aff id="aff14"><sup>14</sup>
Service de Chirurgie Générale, Hépatique, Endocrinienne, et Transplantation, Hôpital de Hautepierre, Les Hôpitaux Universitaires de Strasbourg, Strasbourg, France.</aff>
<aff id="aff15"><sup>15</sup>
Service de Néphrologie-HTA-Dialyse-Transplantation, CHU Toulouse-Rangueil, Toulouse, France.</aff>
<aff id="aff16"><sup>16</sup>
Department of Surgery and Transplantation, Sahlgrenska University Hospital, Göteborg, Sweden.</aff>
<aff id="aff17"><sup>17</sup>
Hepatic-Pancreatico-Biliary Surgical Services and Edinburgh Transplant Unit, Royal Infirmary of Edinburgh, Edinburgh, Scotland, United Kingdom.</aff>
<aff id="aff18"><sup>18</sup>
Service de Chirurgie Digestive, Centre de Transplantation Hépatique, Hôpital ARCHET 2, Centre Hospitalier Universitaire de Nice, Nice, France.</aff>
<aff id="aff19"><sup>19</sup>
Klinik für Allgemein- und Viszeralchirurgie, Universitätsklinikum Münster, Münster, Germany.</aff>
<aff id="aff20"><sup>20</sup>
Hepatobiliary and Pancreatic Surgery Unit, Hopital St Luc, Centre Hospitalier de l'Université Montréal (CHUM), Principal Pavillion, Montreal, Quebec, Canada.</aff>
<aff id="aff21"><sup>21</sup>
Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Universitätsklinikum Essen, Essen, Germany.</aff>
<aff id="aff22"><sup>22</sup>
Klinik für Allgemeine, Viszeral- und Transplantationschirurgie, Klinikum der Universität Tübingen, Tübingen, Germany.</aff>
<aff id="aff23"><sup>23</sup>
Chirurgia Generale e Trapianti d'Organo, Università di Genova-Azienda Ospedaliera Universitaria San Martino di Genova, Genova, Italy.</aff>
<aff id="aff24"><sup>24</sup>
Unidad de Trasplante Hepático, Departamento de Cirugía, Hospital Universitario Puerta de Hierro-Majadahonda, Madrid, Spain.</aff>
<aff id="aff25"><sup>25</sup>
Department of Surgery, NHS Foundation Trust, Addenbrooke's Hospital, Cambridge University Hospitals, Cambridge, United Kingdom.</aff>
<aff id="aff26"><sup>26</sup>
Section for Transplant Surgery, Clinic for Cancer, Surgery and Transplantation, Department of Transplantation Medicine, Oslo University Hospital, Rikshospitalet, Oslo, Norway.</aff>
<aff id="aff27"><sup>27</sup>
Chirurgia terza e Chirurgia Toracica, Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, Italy.</aff>
<aff id="aff28"><sup>28</sup>
Klinik für Allgemeine Chirurgie, Viszeral-, Thorax, Transplantations- und Kinderchirurgie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel, Germany.</aff>
<aff id="aff29"><sup>29</sup>
Department of Transplantation Surgery, Karolinska University Hospital, Stockholm, Sweden.</aff>
<aff id="aff30"><sup>30</sup>
Federation d'Hepato-Gastro-Enterologie, Service d'Hepatologie, Hôpital Saint Antoine, Paris, France.</aff>
<aff id="aff31"><sup>31</sup>
Division of Transplantation and Liver Surgery, Helsinki University Central Hospital, Helsinki, Finland.</aff>
<aff id="aff32"><sup>32</sup>
Service d'Hepato-Gastroentérologie et Transplantation Hepatique, CHRU de Montpellier, APEMAD, Hôpital Saint-Eloi, Montpellier, France.</aff>
<aff id="aff33"><sup>33</sup>
Abteilung für Transplantation, Universitätsklinik für Chirurgie, Medizinische Universität Wien, AKH-Wien, Vienna, Austria.</aff>
<aff id="aff34"><sup>34</sup>
Division of Hepato-Pancreatico-Biliary Surgery and Liver Transplantation, Department of Surgery, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.</aff>
<aff id="aff35"><sup>35</sup>
Abdominale Transplantatiechirurgie, UZ Leuven, Campus Gasthuisberg, Leuven, Belgium.</aff>
<aff id="aff36"><sup>36</sup>
Universitätsklinik für Visceral-, Transplantations-Throaxchirurgie, Medizinische Universität Innsbruck, Innsbruck, Austria.</aff>
<aff id="aff37"><sup>37</sup>
Chirurgia Generale e dei Trapianti, Policlinico S. Orsola-Malpighi, Universita di Bologna, Bologna, Italy.</aff>
<aff id="aff38"><sup>38</sup>
Klinik für Visceral-, Transplantations-, Thorax- und Gefäßchirurgie, Universitätsklinikum Leipzig, Leipzig, Germany.</aff>
<aff id="aff39"><sup>39</sup>
AW Morrow Gastroenterology and Liver Centre and Liver Transplant Unit, Royal Prince Alfred Hospital, Sydney, NSW, Australia.</aff>
<aff id="aff40"><sup>40</sup>
Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Medizinische Hochschule Hannover, Hannover, Germany.</aff>
<aff id="aff41"><sup>41</sup>
Hepato-Biliary and Pancreatic Surgery, Ghent University Hospital and Medical School, Ghent, Belgium.</aff>
<aff id="aff42"><sup>42</sup>
Department of Surgery, Transplantation and Hepatobiliary Cancer Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, National Cancer Institute Milan, Milan, Italy.</aff>
<aff id="aff43"><sup>43</sup>
Department of Abdominal and Transplantation Surgery (SCTA), UCL Transplant Centre, University Hospitals Saint-Luc, Brussels, Belgium.</aff>
<aff id="aff44"><sup>44</sup>
Servicio de Cirugía General, Unidad de Trasplante Hepatico, Hospital Universitari Vall d'Hebron, Barcelona, Spain.</aff>
<aff id="aff45"><sup>45</sup>
The Queen Elizabeth Hospital, Liver and Hepato-Pancreato-Biliary (HPB) Unit, NHS Foundation Trust, University Hospitals Birmingham, Edgbaston, Birmingham, United Kingdom.</aff>
<aff id="aff46"><sup>46</sup>
Klinik für Allgemein-, Visceral- und Transplantationschirurgie, Charité Campus Virchow Klinikum, Universitätsmedizin Berlin, Berlin, Germany.</aff>
<author-notes><corresp id="cor1">Correspondence: Edward K. Geissler, PhD, University Hospital Regensburg, University of Regensburg, Department of Surgery, Section of Experimental Surgery, Franz-Josef-Strauss-Allee 11, D-93053 Regensburg, Germany. (<email>edward.geissler@klinik.uni-regensburg.de</email>
).</corresp>
</author-notes>
<pub-date pub-type="ppub"><month>1</month>
<year>2016</year>
</pub-date>
<pub-date pub-type="epub"><day>16</day>
<month>12</month>
<year>2015</year>
</pub-date>
<volume>100</volume>
<issue>1</issue>
<fpage>116</fpage>
<lpage>125</lpage>
<history><date date-type="received"><day>7</day>
<month>7</month>
<year>2015</year>
</date>
<date date-type="rev-request"><day>28</day>
<month>7</month>
<year>2015</year>
</date>
<date date-type="accepted"><day>6</day>
<month>9</month>
<year>2015</year>
</date>
</history>
<permissions><copyright-statement>Copyright © 2015 Wolters Kluwer Health, Inc. All rights reserved.</copyright-statement>
<copyright-year>2015</copyright-year>
<copyright-holder>Wolters Kluwer Health, Inc. All rights reserved.</copyright-holder>
<license><license-p>This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License, where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially. <ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/licenses/by-nc-nd/3.0">http://creativecommons.org/licenses/by-nc-nd/3.0</ext-link>
.</license-p>
</license>
</permissions>
<self-uri xlink:type="simple" xlink:href="tp-100-116.pdf"></self-uri>
<abstract><title>Background</title>
<p>We investigated whether sirolimus-based immunosuppression improves outcomes in liver transplantation (LTx) candidates with hepatocellular carcinoma (HCC).</p>
<sec><title>Methods</title>
<p>In a prospective-randomized open-label international trial, 525 LTx recipients with HCC initially receiving mammalian target of rapamycin inhibitor–free immunosuppression were randomized 4 to 6 weeks after transplantation into a group on mammalian target of rapamycin inhibitor–free immunosuppression (group A: 264 patients) or a group incorporating sirolimus (group B: 261). The primary endpoint was recurrence-free survival (RFS); intention-to-treat (ITT) analysis was conducted after 8 years. Overall survival (OS) was a secondary endpoint.</p>
</sec>
<sec><title>Results</title>
<p>Recurrence-free survival was 64.5% in group A and 70.2% in group B at study end, this difference was not significant (<italic>P</italic>
= 0.28; hazard ratio [HR], 0.84; 95% confidence interval [95% CI], 0.62; 1.15). In a planned analysis of RFS rates at yearly intervals, group B showed better outcomes 3 years after transplantation (HR, 0.7; 95% CI, 0.48-1.00). Similarly, OS (<italic>P</italic>
= 0.21; HR, 0.81; 95% CI, 0.58-1.13) was not statistically better in group B at study end, but yearly analyses showed improvement out to 5 years (HR, 0.7; 95% CI, 0.49-1.00). Interestingly, subgroup (Milan Criteria-based) analyses revealed that low-risk, rather than high-risk, patients benefited most from sirolimus; furthermore, younger recipients (age ≤60) also benefited, as well sirolimus monotherapy patients. Serious adverse event numbers were alike in groups A (860) and B (874).</p>
</sec>
<sec><title>Conclusions</title>
<p>Sirolimus in LTx recipients with HCC does not improve long-term RFS beyond 5 years. However, a RFS and OS benefit is evident in the first 3 to 5 years, especially in low-risk patients. This trial provides the first high-level evidence base for selecting immunosuppression in LTx recipients with HCC.</p>
</sec>
</abstract>
<abstract abstract-type="toc"><p>In a large prospective randomized open-label international trial, liver transplant recipients for HCC were randomized to receive non-mTOR-inhibitor-based-treatment or mTOR-inhibitor-based-treatment. Results indicate overall sirolimus does not improve long-term recurrence-free survival beyond 5 years while a benefit was seen in low-risk patients. Supplemental digital content is available in the text.</p>
</abstract>
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</pmc>
<affiliations><list><country><li>Allemagne</li>
<li>Australie</li>
<li>Autriche</li>
<li>Belgique</li>
<li>Canada</li>
<li>Espagne</li>
<li>Finlande</li>
<li>France</li>
<li>Italie</li>
<li>Norvège</li>
<li>Pays-Bas</li>
<li>Royaume-Uni</li>
<li>Suède</li>
</country>
<region><li>Alsace (région administrative)</li>
<li>Angleterre</li>
<li>Bade-Wurtemberg</li>
<li>Basse-Saxe</li>
<li>Bavière</li>
<li>Berlin</li>
<li>Catalogne</li>
<li>Communauté de Madrid</li>
<li>District de Darmstadt</li>
<li>District de Haute-Bavière</li>
<li>District de Karlsruhe</li>
<li>District de Leipzig</li>
<li>District de Münster</li>
<li>District de Tübingen</li>
<li>Grand Est</li>
<li>Groningue (province)</li>
<li>Hesse (Land)</li>
<li>Hollande-Méridionale</li>
<li>Languedoc-Roussillon</li>
<li>Lombardie</li>
<li>Midi-Pyrénées</li>
<li>Midlands de l'Ouest</li>
<li>Occitanie (région administrative)</li>
<li>Provence-Alpes-Côte d'Azur</li>
<li>Rhénanie-Palatinat</li>
<li>Rhénanie-du-Nord-Westphalie</li>
<li>Région de Bruxelles-Capitale</li>
<li>Saxe (Land)</li>
<li>Schleswig-Holstein</li>
<li>Svealand</li>
<li>Vienne (Autriche)</li>
<li>Vénétie</li>
<li>Émilie-Romagne</li>
<li>Île-de-France</li>
<li>Østlandet</li>
</region>
<settlement><li>Barcelone</li>
<li>Berlin</li>
<li>Birmingham</li>
<li>Bologne</li>
<li>Bruxelles</li>
<li>Francfort-sur-le-Main</li>
<li>Groningue</li>
<li>Hanovre</li>
<li>Heidelberg</li>
<li>Kiel</li>
<li>Leipzig</li>
<li>Leyde</li>
<li>Madrid</li>
<li>Mayence</li>
<li>Milan</li>
<li>Montpellier</li>
<li>Munich</li>
<li>Münster</li>
<li>Nice</li>
<li>Oslo</li>
<li>Padoue</li>
<li>Paris</li>
<li>Stockholm</li>
<li>Strasbourg</li>
<li>Toulouse</li>
<li>Tübingen</li>
<li>Vienne (Autriche)</li>
</settlement>
<orgName><li>Université de Bologne</li>
<li>Université de Padoue</li>
</orgName>
</list>
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<name sortKey="Hauss, Johann" sort="Hauss, Johann" uniqKey="Hauss J" first="Johann" last="Hauss">Johann Hauss</name>
<name sortKey="Jauch, Karl Walter" sort="Jauch, Karl Walter" uniqKey="Jauch K" first="Karl-Walter" last="Jauch">Karl-Walter Jauch</name>
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