Recruiting

LBP

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT06887205

Conditions

Lymphatic Reconstruction

Lymphadenectomy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Lymphovenous bypass (LVB)

Study Details

Brief summary:

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.

Conditions

Lymphatic Reconstruction

Lymphadenectomy

Study ID

NCT06887205

Start date

Jun 10, 2026

Status verified date

Jun, 2026

Completion date

Sep 1, 2028

Anticipated

Primary completion date

Sep 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

20 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Upper extremity group recieving ALND

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

experimental: Lower extremity group getting ILND

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

Interventions

Lymphovenous bypass (LVB)

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

Primary outcome measure

  • Safety and adverse events [ Time Frame: Through study completion; an average of 1 year ]

Central Contacts and Locations

Central contacts

Ashleigh M Francis, MD

(713) 413-7451amfrancis@mdanderson.org

Locations

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Ashleigh M Francis, MD

713-413-7451amfrancis@mdanderson.org

Principal Investigator:

Ashleigh M Francis, MD

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Jun 18, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-06-18.