Recruiting

LBP

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT05992909

Conditions

Lymphadenectomy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Lymphovenous bypass procedure

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

Lymphadenectomy

Study ID

NCT05992909

Start date

Aug 2, 2023

Status verified date

Jun, 2026

Completion date

Aug 1, 2027

Anticipated

Primary completion date

Aug 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Eligibility Criteria:

1. Patients greater than or equal to 18 years of age.
2. Patients willing to participate.
3. Patients able to complete informed consent.
4. Patients undergoing ILND and/or PLND.

Exclusion Criteria:

1. Patients taking anticoagulants within 7 days prior to surgery.
2. Patients that are known to be pregnant at the time of surgery.
3. Patients are available for follow-up less than 18 months or do not undergo measurements within the scheduled period.
4. Patients with BMI greater than 50.0.

Study Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Arms

Lymphovenous bypass procedure (LBP)

A surgical procedure for treating lymphedema called lymphovenous bypass procedure (LBP), but it is usually only done after a patient develops lymphedema

Interventions

Lymphovenous bypass procedure

Participants will return to the clinic 14 days, 6 months, 12 months, 18 months, and 24 months after your surgery for measurements of your legs to see if there are changes over time

Primary outcome measure

  • Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 4.03 [ Time Frame: through study completion; an average of 1 year ]

Central Contacts and Locations

Central contacts

Ashleigh Francis, MD

713-563-4598amfrancis@mdanderson.org

Locations

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Jun 16, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-06-16.