Home › Breast Cancer › NCT03941756
Lymphovenous Bypass Procedure Before Underarm Lymph Node Surgery in Preventing Lymphedema in Patients With Inflammatory or Locally Advanced Non-inflammatory Breast Cancer or Melanoma
Prophylactic Lymphovenous Bypass Procedure Following Axillary Lymphadenectomy: A Prospective Observational Study
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria: * Patients greater than or equal to 18 years of age. * Patients willing to participate. * Patients able to complete informed consent. * Patients will be eligible for inclusion if they fall into one for two groups: * Patients with inflammatory breast cancer, and those with locally advanced non-inflammatory breast cancer that are undergoing ALND and are anticipated to receive radiation therapy * Or: Patients with a diagnosis of melanoma (including unknown primary) that will undergo ALND will also be eligible for inclusion in the study as a comparator group. Exclusion Criteria: * Patients taking anticoagulants within 7 days prior to surgery. * Patients that are known to be pregnant at the time of surgery. * Patients are available for follow-up less than 18 months or do not undergo measurements within the scheduled period. * Patients with body mass index (BMI) greater than 50.0.
About the study
This pilot trial studies whether a procedure called lymphovenous bypass would prevent lymphedema (arm swelling) in patients with inflammatory breast cancer or non-inflammatory breast cancer that has spread to nearby tissues or lymph nodes or melanoma. The lymphovenous bypass procedure creates a path for lymphatic fluid to flow away from the arms. It is usually done after a diagnosis of lymphedema. In this study, giving lymphovenous bypass before underarm lymph node surgery may help prevent lymphedema from forming.
What is being tested
- Indocyanine Green (drug)
- Lymphangiography (procedure)
- Lymphovenous Bypass (procedure)
Sponsor: M.D. Anderson Cancer Center · Participants: 252 · Started: Aug 14, 2018
Contact the study team
Official record on ClinicalTrials.gov — NCT03941756
Locations in the U.S.
| Texas | M D Anderson Cancer Center, Houston |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.