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NCT Number: NCT06887205

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

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.

Recruiting

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Key information

Conditions

Lymphatic Reconstruction Lymphadenectomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location status: Recruiting

Location contact

Ashleigh M Francis, MD

CONTACT

[email protected]

713-413-7451

Ashleigh M Francis, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Lymphovenous bypass (LVB)

Procedure

At the time of axillary lymph node dissection (ALND) or inguinal lymph node dissection (ILND) in the melanoma patient population.

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Ashleigh M Francis, MD

CONTACT

[email protected]

(713) 413-7451

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 20, 2025
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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