NCT03428581

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
264

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2017

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 9, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

April 10, 2018

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 11, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 11, 2025

Completed
Last Updated

February 24, 2026

Status Verified

January 1, 2026

Enrollment Period

7.3 years

First QC Date

October 23, 2017

Last Update Submit

February 20, 2026

Conditions

LymphedemaBreast CancerMelanoma

Keywords

AxillaryLymph nodeDissectionReverse MappingLympho-venous Bypass (LVB)Axillary Reverse Mapping (ARM)

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

ALND with ARM +/- LVB

EXPERIMENTAL

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

Procedure: ALND with ARM +/- LVB

ALND without ARM +/- LVB

ACTIVE COMPARATOR

Axillary Lymph Node Dissection (ALND)

Procedure: ALND

Interventions

ALND with ARM +/- LVBPROCEDURE

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 with ARM +/- LVB
ALNDPROCEDURE

Prospective and retrospective subjects undergoing an ALND.

ALND without ARM +/- LVB

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

LymphedemaBreast NeoplasmsMelanoma

Condition Hierarchy (Ancestors)

Lymphatic DiseasesHemic and Lymphatic DiseasesNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Nerve TissueNevi and MelanomasSkin Neoplasms

Study Officials

  • James W Jakub, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

  • Mara A. Piltin, DO

    Mayo Clinic in Rochester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 23, 2017

First Posted

February 9, 2018

Study Start

April 10, 2018

Primary Completion

July 11, 2025

Study Completion

July 11, 2025

Last Updated

February 24, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(2)