Immediate Lymphatic Reconstruction After Lymphadenectomy in Melanoma Patients: a Parallel Cohort Pilot Study

April 21, 2026 updated by: M.D. Anderson Cancer Center
To learn if LBP can help to prevent lymphedema when it is performed at the time of surgery rather than after a patient has already developed the disease.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

To examine if performing lymphovenous bypass (LVB) at the time of axillary lymph node dissection (ALND) or inguinal lymph node dissection (ILND) in the melanoma participant population impacts the period prevalence of lymphedema occurrence one year from surgery. To assess wound complications rates occurring in first 30-days post operatively from the time of surgery. To estimate time to drain removal. To estimate the point prevalence of LE following surgery at 3 months, 6 months, and 1 year following surgery. To estimate the cumulative incidence associated with the first appearance of LE. To assess quality of life and survivorship, using Lymphedema Quality of Life (LYMQOL) questionnaire over the study follow-up domain.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Md Anderson Cancer Center
        • Principal Investigator:
          • Ashleigh M Francis, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Participants greater than or equal to 18 years of age.
  2. Participants willing to participate.
  3. Participants able to complete informed consent.
  4. Participants with a diagnosis of Melanoma undergoing ALND or ILND.

Exclusion Criteria:

  1. Participant staking anticoagulants within 7 days prior to surgery.
  2. Participants that are known to be pregnant at the time of surgery.
  3. Participants with BMI greater than 50.0

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Upper extremity group recieving ALND
Participants will be recruited pre-operatively by their treating physicians.
Procedure: Lymphovenous bypass (LVB)
At the time of axillary lymph node dissection (ALND) or inguinal lymph node dissection (ILND) in the melanoma patient population.
Experimental: Lower extremity group getting ILND
Participants will be recruited pre-operatively by their treating physicians.
Procedure: Lymphovenous bypass (LVB)
At the time of axillary lymph node dissection (ALND) or inguinal lymph node dissection (ILND) in the melanoma patient population.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and adverse events
Time Frame: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events
Through study completion; an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Ashleigh M Francis, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 6, 2026

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 1, 2028

Study Registration Dates

First Submitted

March 14, 2025

First Submitted That Met QC Criteria

March 14, 2025

First Posted (Actual)

March 20, 2025

Study Record Updates

Last Update Posted (Actual)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-1357
  • NCI-2025-01923 (Other Identifier: NCI-CTRP Clinical Registry)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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