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The clinical relevance of axillary reverse mapping (ARM): study protocol for a randomized controlled trial
BACKGROUND: 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...
Autores principales: | , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2013
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3663653/ https://www.ncbi.nlm.nih.gov/pubmed/23782712 http://dx.doi.org/10.1186/1745-6215-14-111 |
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author | Klompenhouwer, Elisabeth G Gobardhan, Paul D Beek, Martinus A Voogd, Adri C Luiten, Ernest JT |
author_facet | Klompenhouwer, Elisabeth G Gobardhan, Paul D Beek, Martinus A Voogd, Adri C Luiten, Ernest JT |
author_sort | Klompenhouwer, Elisabeth G |
collection | PubMed |
description | BACKGROUND: 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. METHODS/DESIGN: 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 in situ. 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. DISCUSSION: 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. TRIAL REGISTRATION: TC3698 |
format | Online Article Text |
id | pubmed-3663653 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2013 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-36636532013-05-25 The clinical relevance of axillary reverse mapping (ARM): study protocol for a randomized controlled trial Klompenhouwer, Elisabeth G Gobardhan, Paul D Beek, Martinus A Voogd, Adri C Luiten, Ernest JT Trials Study Protocol BACKGROUND: 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. METHODS/DESIGN: 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 in situ. 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. DISCUSSION: 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. TRIAL REGISTRATION: TC3698 BioMed Central 2013-04-25 /pmc/articles/PMC3663653/ /pubmed/23782712 http://dx.doi.org/10.1186/1745-6215-14-111 Text en Copyright © 2013 Klompenhouwer et al.; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Study Protocol Klompenhouwer, Elisabeth G Gobardhan, Paul D Beek, Martinus A Voogd, Adri C Luiten, Ernest JT The clinical relevance of axillary reverse mapping (ARM): study protocol for a randomized controlled trial |
title | The clinical relevance of axillary reverse mapping (ARM): study protocol for a randomized controlled trial |
title_full | The clinical relevance of axillary reverse mapping (ARM): study protocol for a randomized controlled trial |
title_fullStr | The clinical relevance of axillary reverse mapping (ARM): study protocol for a randomized controlled trial |
title_full_unstemmed | The clinical relevance of axillary reverse mapping (ARM): study protocol for a randomized controlled trial |
title_short | The clinical relevance of axillary reverse mapping (ARM): study protocol for a randomized controlled trial |
title_sort | clinical relevance of axillary reverse mapping (arm): study protocol for a randomized controlled trial |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3663653/ https://www.ncbi.nlm.nih.gov/pubmed/23782712 http://dx.doi.org/10.1186/1745-6215-14-111 |
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