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
3 other identifiers
interventional
252
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 14, 2018
CompletedFirst Submitted
Initial submission to the registry
May 6, 2019
CompletedFirst Posted
Study publicly available on registry
May 8, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedNovember 10, 2025
November 1, 2025
7.4 years
May 6, 2019
November 6, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Volumetric diagnosis of lymphedema
If the limb volume change, meets the criteria for a diagnosis of lymphedema at any time (5 percent, change), then the patient receives a diagnosis of lymphedema.
18 months
Incidence of lymphedema
Will compare the incidence of lymphedema after mastectomy and axillary lymph node dissection surgery between two surgical techniques.
18 months
Study Arms (2)
Group I (LVB)
EXPERIMENTALPatients receive indocyanine green IV and undergo lymphangiography, then undergo LVB at the time of ALND.
Group II (no intervention)
NO INTERVENTIONPatients do not receive indocyanine green, undergo lymphangiography, nor undergo LVB at the time of ALND.
Interventions
Eligibility Criteria
You may qualify if:
- Patients greater than or equal to 18 years of age.
- Patients willing to participate.
- Patients able to complete informed consent.
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark Schaverien
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 6, 2019
First Posted
May 8, 2019
Study Start
August 14, 2018
Primary Completion
December 31, 2025
Study Completion
December 31, 2025
Last Updated
November 10, 2025
Record last verified: 2025-11