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

M.D. Anderson Cancer Center

Status: Begins enrollment in 6 months

Conditions: Lymphadenectomy; Lymphatic Reconstruction

Treatments: Procedure: Lymphovenous bypass (LVB)

Study type: Interventional

Funder types: Other

Identifiers

NCT06887205

NCI-2025-01923 (Other Identifier)

2024-1357

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

20 participants in 2 patient groups

Upper extremity group recieving ALND

Experimental group

Description:

Participants will be recruited pre-operatively by their treating physicians.

Treatment:

Procedure: Lymphovenous bypass (LVB)

Lower extremity group getting ILND

Experimental group

Description:

Participants will be recruited pre-operatively by their treating physicians.

Treatment:

Procedure: Lymphovenous bypass (LVB)