Preventing Lymphedema in Axillary Lymph Node Dissection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

264 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-10

Study Completion Date

2026-02-28

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.

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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.

Conditions

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Lymphedema Breast Cancer Melanoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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ALND with ARM +/- LVB

Axillary Lymph Node Dissection (ALND) using Axillary Reverse Mapping (ARM) with Lympho-venous bypass (LVB) will be performed.

Group Type EXPERIMENTAL

ALND with ARM +/- LVB

Intervention Type PROCEDURE

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.

ALND without ARM +/- LVB

Axillary Lymph Node Dissection (ALND)

Group Type ACTIVE_COMPARATOR

ALND

Intervention Type PROCEDURE

Prospective and retrospective subjects undergoing an ALND.

Interventions

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ALND with ARM +/- LVB

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.

Intervention Type PROCEDURE

ALND

Prospective and retrospective subjects undergoing an ALND.

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No