Prophylactic Lymphovenous Bypass Procedure Following Inguinal Lymphadenectomy: A Prospective Observational Study

May 18, 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

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Primary Objectives:

The objective of this study is to evaluate the protective benefit to performing LVB surgery at the time of ILND. In the secondary objective, we will compare the medical outcomes for patients that received the LVB surgery with those receiving standard surgery in whom the intervention could not be performed.

Study Type

Observational

Enrollment (Estimated)

20

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
        • Recruiting
        • Md Anderson Cancer Center

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

Sampling Method

Non-Probability Sample

Study Population

M D Anderson Cancer Center

Description

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.

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 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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Procedure: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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 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 (Actual)

August 2, 2023

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

August 4, 2023

First Submitted That Met QC Criteria

August 7, 2023

First Posted (Actual)

August 15, 2023

Study Record Updates

Last Update Posted (Actual)

May 20, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 2023-0203
  • NCI-2023-06282 (Other Identifier: NCI-Clinical Trials 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

product manufactured in and exported from the U.S.

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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