Preventing Lymphedema in Axillary Lymph Node Dissection

Study Overview
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Brief Summary
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The researchers are trying to answer if axillary reverse mapping (ARM) with lympho-venous bypass (LVB) in patients undergoing an axillary lymph node dissection reduces the rate and severity of post-operative lymphedema of the arm.

Detailed Description
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All subjects will undergo an axillary lymph node dissection (ALND). Cluster randomization will determine which of these subjects will have the ARM with LVB and which subjects will have the ALND without this technique. As a baseline, all subjects will have the circumference of their arms measured and complete a questionnaire about lymphedema. Performing the measurements and answering a questionnaire will be repeated at 6, 12, 24, and 36 months after surgery.

Official Title
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Preventing Lymphedema in Patients Undergoing Axillary Lymph Node Dissection Via Axillary Reverse Mapping and Lympho-venous Bypass

Conditions
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Lymphedema, Breast Cancer, Melanoma

Intervention / Treatment
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* Procedure: ALND with ARM +/- LVB
* Procedure: ALND


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Patients scheduled to undergo an axillary lymph node dissection Patients who in the surgeon's judgement are at high risk to convert to an axillary lymph node dissection based intraoperative findings English speaking Exclusion Criteria Prior ipsilateral axillary lymph node dissection Prior ipsilateral axillary radiation Patients undergoing sentinel lymph node biopsy only or at low risk of converting to an axillary lymph node dissection in the surgeon's judgement Previous treatment for lymphedema of either arm or prescribed prophylactic treatment for lymphedema. Pregnant patients cannot participate in the substudy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ALND with ARM +/- LVB<br>Axillary Lymph Node Dissection (ALND) using Axillary Reverse Mapping (ARM) with Lympho-venous bypass (LVB) will be performed. | Procedure: ALND with ARM +/- LVB<br>* Subjects will undergo removal of the lymph nodes in the underarm or axilla area. This is referred to as an axillary lymph node dissection (ALND). The procedure for identifying the drainage of the arm lymphatics during an axillary dissection has been coined axillary reverse mapping (ARM). Lympho-venous bypass (LVB) is a technique incorporated along with the ARM procedure that allows preservation of the lymphatics draining the arm while removing the standard lymph nodes and not compromising the extent of the axillary dissection.<br>|
| Active Comparator: ALND without ARM +/- LVB<br>Axillary Lymph Node Dissection (ALND) | Procedure: ALND<br>* Prospective and retrospective subjects undergoing an ALND.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Less than 5% limb volume increase in the study extremity compared to baseline and the control extremity | Bilateral Limb volume measurements | 36 months following surgery | 
| Less frequently reported symptoms of lymphedema in the study extremity compared to baseline and the control extremity | Validated patient reported surveys | 36 months following surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Axillary, Lymph node, Dissection, Reverse Mapping, Lympho-venous Bypass (LVB), Axillary Reverse Mapping (ARM)