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Preventing Lymphedema in Axillary Lymph Node Dissection

NCT03428581 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 264

Last updated 2026-02-24

No results posted yet for this study

Summary

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.

Conditions

Interventions

PROCEDURE

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.

PROCEDURE

ALND

Prospective and retrospective subjects undergoing an ALND.

Sponsors & Collaborators

Principal Investigators

  • James W Jakub, MD · Mayo Clinic

  • Mara A. Piltin, DO · Mayo Clinic in Rochester

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-10
Primary Completion
2025-07-11
Completion
2025-07-11

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03428581 on ClinicalTrials.gov