The clinical relevance of axillary reverse mapping (ARM): study protocol for a randomized controlled trial
Identifieur interne : 003080 ( Main/Exploration ); précédent : 003079; suivant : 003081The clinical relevance of axillary reverse mapping (ARM): study protocol for a randomized controlled trial
Auteurs : Elisabeth G. Klompenhouwer [Pays-Bas] ; Paul D. Gobardhan [Pays-Bas] ; Martinus A. Beek [Pays-Bas] ; Adri C. Voogd [Pays-Bas] ; Ernest Jt Luiten [Pays-Bas]Source :
- Trials [ 1745-6215 ] ; 2013.
Descripteurs français
- KwdFr :
- Aisselle, Biopsie de noeud lymphatique sentinelle, Facteurs temps, Femelle, Humains, Invasion tumorale, Lymphadénectomie (), Lymphadénectomie (effets indésirables), Lymphoedème (), Lymphoedème (étiologie), Métastase lymphatique, Noeuds lymphatiques (), Noeuds lymphatiques (anatomopathologie), Pays-Bas, Plan de recherche, Protocoles cliniques, Résultat thérapeutique, Tumeurs du sein (), Tumeurs du sein (anatomopathologie).
- MESH :
- anatomopathologie : Noeuds lymphatiques, Tumeurs du sein.
- effets indésirables : Lymphadénectomie.
- étiologie : Lymphoedème.
- Aisselle, Biopsie de noeud lymphatique sentinelle, Facteurs temps, Femelle, Humains, Invasion tumorale, Lymphadénectomie, Lymphoedème, Métastase lymphatique, Noeuds lymphatiques, Pays-Bas, Plan de recherche, Protocoles cliniques, Résultat thérapeutique, Tumeurs du sein.
- Wicri :
- geographic : Pays-Bas.
English descriptors
- KwdEn :
- Axilla, Breast Neoplasms (pathology), Breast Neoplasms (surgery), Clinical Protocols, Female, Humans, Lymph Node Excision (adverse effects), Lymph Node Excision (methods), Lymph Nodes (pathology), Lymph Nodes (surgery), Lymphatic Metastasis, Lymphedema (etiology), Lymphedema (prevention & control), Neoplasm Invasiveness, Netherlands, Research Design, Sentinel Lymph Node Biopsy, Time Factors, Treatment Outcome.
- MESH :
- geographic : Netherlands.
- adverse effects : Lymph Node Excision.
- etiology : Lymphedema.
- methods : Lymph Node Excision.
- pathology : Breast Neoplasms, Lymph Nodes.
- prevention & control : Lymphedema.
- surgery : Breast Neoplasms, Lymph Nodes.
- Axilla, Clinical Protocols, Female, Humans, Lymphatic Metastasis, Neoplasm Invasiveness, Research Design, Sentinel Lymph Node Biopsy, Time Factors, Treatment Outcome.
Abstract
Axillary lymph node dissection (ALND) in patients with breast cancer has the potential to induce side-effects, including upper-limb lymphedema. Axillary reverse mapping (ARM) is a technique that enables discrimination of the lymphatic drainage of the breast from that of the upper limb in the axillary lymph node (LN) basin. If lymphedema is caused by removing these lymphatics and nodes in the upper limb, the possibility of identifying these lymphatics would enable surgeons to preserve them. The aim of this study is to determine the clinical relevance of selective axillary LN and lymphatic preservation by means of ARM. To minimize the risk of overlooking tumor-positive ARM nodes and the associated risk of undertreatment, we will only include patients with a tumor-positive sentinel lymph node (SLN). Patients who are candidates for ALND because of a proven positive axillary LN at clinical examination can be included in a registration study.
The study will enroll 280 patients diagnosed with SLN biopsy-proven metastasis of invasive breast cancer with an indication for a completion ALND. Patients will be randomized to undergo standard ALND or an ALND in which the ARM nodes and their corresponding lymphatics will be left
The benefit of ALND in patients with a positive SLN is a subject of debate. For many patients, an ALND will remain the treatment of choice. This multicenter randomized trial will provide evidence of whether or not axillary LN preservation by means of ARM decreases the side-effects of an ALND. Enrolment of patients will start in April 2013 in five breast-cancer centers in the Netherlands, and is expected to conclude by April 2016.
Url:
DOI: 10.1186/1745-6215-14-111
PubMed: 23782712
PubMed Central: 3663653
Affiliations:
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Klompenhouwer</name><affiliation wicri:level="1"><nlm:aff id="I1">Department of Radiology, Catharina Hospital Eindhoven, Eindhoven, the Netherlands</nlm:aff><country xml:lang="fr" wicri:curation="lc">Pays-Bas</country><wicri:regionArea>Department of Radiology, Catharina Hospital Eindhoven, Eindhoven</wicri:regionArea><wicri:noRegion>Eindhoven</wicri:noRegion></affiliation></author><author><name sortKey="Gobardhan, Paul D" sort="Gobardhan, Paul D" uniqKey="Gobardhan P" first="Paul D" last="Gobardhan">Paul D. Gobardhan</name><affiliation wicri:level="1"><nlm:aff id="I2">Department of Surgery, Amphia Hospital, Molengracht 21, 4818, CK Breda, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Surgery, Amphia Hospital, Molengracht 21, 4818, CK Breda</wicri:regionArea><wicri:noRegion>CK Breda</wicri:noRegion></affiliation></author><author><name sortKey="Beek, Martinus A" sort="Beek, Martinus A" uniqKey="Beek M" first="Martinus A" last="Beek">Martinus A. Beek</name><affiliation wicri:level="1"><nlm:aff id="I2">Department of Surgery, Amphia Hospital, Molengracht 21, 4818, CK Breda, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Surgery, Amphia Hospital, Molengracht 21, 4818, CK Breda</wicri:regionArea><wicri:noRegion>CK Breda</wicri:noRegion></affiliation></author><author><name sortKey="Voogd, Adri C" sort="Voogd, Adri C" uniqKey="Voogd A" first="Adri C" last="Voogd">Adri C. Voogd</name><affiliation wicri:level="1"><nlm:aff id="I3">Department of Epidemiology, Maastricht University, Maastricht, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Epidemiology, Maastricht University, Maastricht</wicri:regionArea><wicri:noRegion>Maastricht</wicri:noRegion></affiliation><affiliation wicri:level="1"><nlm:aff id="I4">Faculty of Health Medicine and Life Sciences, Maastricht University, Maastricht, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Faculty of Health Medicine and Life Sciences, Maastricht University, Maastricht</wicri:regionArea><wicri:noRegion>Maastricht</wicri:noRegion></affiliation><affiliation wicri:level="1"><nlm:aff id="I5">Research Institute Growth and Development (GROW), Maastricht University, Maastricht, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Research Institute Growth and Development (GROW), Maastricht University, Maastricht</wicri:regionArea><wicri:noRegion>Maastricht</wicri:noRegion></affiliation><affiliation wicri:level="1"><nlm:aff id="I6">Eindhoven Cancer Registry, Comprehensive Cancer Center South, Eindhoven, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Eindhoven Cancer Registry, Comprehensive Cancer Center South, Eindhoven</wicri:regionArea><wicri:noRegion>Eindhoven</wicri:noRegion></affiliation></author><author><name sortKey="Luiten, Ernest Jt" sort="Luiten, Ernest Jt" uniqKey="Luiten E" first="Ernest Jt" last="Luiten">Ernest Jt Luiten</name><affiliation wicri:level="1"><nlm:aff id="I2">Department of Surgery, Amphia Hospital, Molengracht 21, 4818, CK Breda, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Surgery, Amphia Hospital, Molengracht 21, 4818, CK Breda</wicri:regionArea><wicri:noRegion>CK Breda</wicri:noRegion></affiliation></author></analytic><series><title level="j">Trials</title><idno type="eISSN">1745-6215</idno><imprint><date when="2013">2013</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Axilla</term><term>Breast Neoplasms (pathology)</term><term>Breast Neoplasms (surgery)</term><term>Clinical Protocols</term><term>Female</term><term>Humans</term><term>Lymph Node Excision (adverse effects)</term><term>Lymph Node Excision (methods)</term><term>Lymph Nodes (pathology)</term><term>Lymph Nodes (surgery)</term><term>Lymphatic Metastasis</term><term>Lymphedema (etiology)</term><term>Lymphedema (prevention & control)</term><term>Neoplasm Invasiveness</term><term>Netherlands</term><term>Research Design</term><term>Sentinel Lymph Node Biopsy</term><term>Time Factors</term><term>Treatment Outcome</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Aisselle</term><term>Biopsie de noeud lymphatique sentinelle</term><term>Facteurs temps</term><term>Femelle</term><term>Humains</term><term>Invasion tumorale</term><term>Lymphadénectomie ()</term><term>Lymphadénectomie (effets indésirables)</term><term>Lymphoedème ()</term><term>Lymphoedème (étiologie)</term><term>Métastase lymphatique</term><term>Noeuds lymphatiques ()</term><term>Noeuds lymphatiques (anatomopathologie)</term><term>Pays-Bas</term><term>Plan de recherche</term><term>Protocoles cliniques</term><term>Résultat thérapeutique</term><term>Tumeurs du sein ()</term><term>Tumeurs du sein (anatomopathologie)</term></keywords><keywords scheme="MESH" type="geographic" xml:lang="en"><term>Netherlands</term></keywords><keywords scheme="MESH" qualifier="adverse effects" xml:lang="en"><term>Lymph Node Excision</term></keywords><keywords scheme="MESH" qualifier="anatomopathologie" xml:lang="fr"><term>Noeuds lymphatiques</term><term>Tumeurs du sein</term></keywords><keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr"><term>Lymphadénectomie</term></keywords><keywords scheme="MESH" qualifier="etiology" xml:lang="en"><term>Lymphedema</term></keywords><keywords scheme="MESH" qualifier="methods" xml:lang="en"><term>Lymph Node Excision</term></keywords><keywords scheme="MESH" qualifier="pathology" xml:lang="en"><term>Breast Neoplasms</term><term>Lymph Nodes</term></keywords><keywords scheme="MESH" qualifier="prevention & control" xml:lang="en"><term>Lymphedema</term></keywords><keywords scheme="MESH" qualifier="surgery" xml:lang="en"><term>Breast Neoplasms</term><term>Lymph Nodes</term></keywords><keywords scheme="MESH" qualifier="étiologie" xml:lang="fr"><term>Lymphoedème</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Axilla</term><term>Clinical Protocols</term><term>Female</term><term>Humans</term><term>Lymphatic Metastasis</term><term>Neoplasm Invasiveness</term><term>Research Design</term><term>Sentinel Lymph Node Biopsy</term><term>Time Factors</term><term>Treatment Outcome</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Aisselle</term><term>Biopsie de noeud lymphatique sentinelle</term><term>Facteurs temps</term><term>Femelle</term><term>Humains</term><term>Invasion tumorale</term><term>Lymphadénectomie</term><term>Lymphoedème</term><term>Métastase lymphatique</term><term>Noeuds lymphatiques</term><term>Pays-Bas</term><term>Plan de recherche</term><term>Protocoles cliniques</term><term>Résultat thérapeutique</term><term>Tumeurs du sein</term></keywords><keywords scheme="Wicri" type="geographic" xml:lang="fr"><term>Pays-Bas</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Background</title><p>Axillary lymph node dissection (ALND) in patients with breast cancer has the potential to induce side-effects, including upper-limb lymphedema. Axillary reverse mapping (ARM) is a technique that enables discrimination of the lymphatic drainage of the breast from that of the upper limb in the axillary lymph node (LN) basin. If lymphedema is caused by removing these lymphatics and nodes in the upper limb, the possibility of identifying these lymphatics would enable surgeons to preserve them. The aim of this study is to determine the clinical relevance of selective axillary LN and lymphatic preservation by means of ARM. To minimize the risk of overlooking tumor-positive ARM nodes and the associated risk of undertreatment, we will only include patients with a tumor-positive sentinel lymph node (SLN). Patients who are candidates for ALND because of a proven positive axillary LN at clinical examination can be included in a registration study.</p></sec><sec><title>Methods/design</title><p>The study will enroll 280 patients diagnosed with SLN biopsy-proven metastasis of invasive breast cancer with an indication for a completion ALND. Patients will be randomized to undergo standard ALND or an ALND in which the ARM nodes and their corresponding lymphatics will be left <italic>in situ</italic>. Primary outcome is the presence of axillary surgery-related lymphedema at 6, 12, and 24 months post-operatively, measured by the water-displacement method. Secondary outcome measures include pain, paresthesia, numbness, and loss of shoulder mobility, quality of life, and axillary recurrence risk.</p></sec><sec><title>Discussion</title><p>The benefit of ALND in patients with a positive SLN is a subject of debate. For many patients, an ALND will remain the treatment of choice. This multicenter randomized trial will provide evidence of whether or not axillary LN preservation by means of ARM decreases the side-effects of an ALND. Enrolment of patients will start in April 2013 in five breast-cancer centers in the Netherlands, and is expected to conclude by April 2016.</p></sec><sec><title>Trial registration</title><p><ext-link ext-link-type="uri" xlink:href="http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3698">TC3698</ext-link></p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Hack, Tf" uniqKey="Hack T">TF Hack</name></author><author><name sortKey="Cohen, L" uniqKey="Cohen L">L Cohen</name></author><author><name sortKey="Katz, J" uniqKey="Katz J">J Katz</name></author><author><name sortKey="Robson, Ls" uniqKey="Robson L">LS Robson</name></author><author><name sortKey="Goss, P" uniqKey="Goss P">P Goss</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Schijven, Mp" uniqKey="Schijven M">MP Schijven</name></author><author><name sortKey="Vingerhoets, Aj" uniqKey="Vingerhoets A">AJ 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Begovic</name></author><author><name sortKey="Sharif, S" uniqKey="Sharif S">S Sharif</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Sakorafas, Gh" uniqKey="Sakorafas G">GH Sakorafas</name></author><author><name sortKey="Peros, G" uniqKey="Peros G">G Peros</name></author><author><name sortKey="Cataliotti, L" uniqKey="Cataliotti L">L Cataliotti</name></author><author><name sortKey="Vlastos, G" uniqKey="Vlastos G">G Vlastos</name></author></analytic></biblStruct><biblStruct></biblStruct></listBibl></div1></back></TEI><affiliations><list><country><li>Pays-Bas</li></country></list><tree><country name="Pays-Bas"><noRegion><name sortKey="Klompenhouwer, Elisabeth G" sort="Klompenhouwer, Elisabeth G" uniqKey="Klompenhouwer E" first="Elisabeth G" last="Klompenhouwer">Elisabeth G. Klompenhouwer</name></noRegion><name sortKey="Beek, Martinus A" sort="Beek, Martinus A" uniqKey="Beek M" first="Martinus A" last="Beek">Martinus A. Beek</name><name sortKey="Gobardhan, Paul D" sort="Gobardhan, Paul D" uniqKey="Gobardhan P" first="Paul D" last="Gobardhan">Paul D. Gobardhan</name><name sortKey="Luiten, Ernest Jt" sort="Luiten, Ernest Jt" uniqKey="Luiten E" first="Ernest Jt" last="Luiten">Ernest Jt Luiten</name><name sortKey="Voogd, Adri C" sort="Voogd, Adri C" uniqKey="Voogd A" first="Adri C" last="Voogd">Adri C. Voogd</name><name sortKey="Voogd, Adri C" sort="Voogd, Adri C" uniqKey="Voogd A" first="Adri C" last="Voogd">Adri C. Voogd</name><name sortKey="Voogd, Adri C" sort="Voogd, Adri C" uniqKey="Voogd A" first="Adri C" last="Voogd">Adri C. Voogd</name><name sortKey="Voogd, Adri C" sort="Voogd, Adri C" uniqKey="Voogd A" first="Adri C" last="Voogd">Adri C. Voogd</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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