Status:
ACTIVE_NOT_RECRUITING
Preventing Lymphedema in Axillary Lymph Node Dissection
Lead Sponsor:
Mayo Clinic
Conditions:
Lymphedema
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The researchers are trying to answer if axillary reverse mapping (ARM) with lympho-venous bypass (LVB) in patients undergoing an axillary lymph node dissection reduces the rate and severity of post-op...
Detailed Description
All subjects will undergo an axillary lymph node dissection (ALND). Cluster randomization will determine which of these subjects will have the ARM with LVB and which subjects will have the ALND withou...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Patients scheduled to undergo an axillary lymph node dissection
- Patients who in the surgeon's judgement are at high risk to convert to an axillary lymph node dissection based intraoperative findings
- English speaking
- Exclusion Criteria
- Prior ipsilateral axillary lymph node dissection
- Prior ipsilateral axillary radiation
- Patients undergoing sentinel lymph node biopsy only or at low risk of converting to an axillary lymph node dissection in the surgeon's judgement
- Previous treatment for lymphedema of either arm or prescribed prophylactic treatment for lymphedema.
- Pregnant patients cannot participate in the substudy
Exclusion
Key Trial Info
Start Date :
April 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2026
Estimated Enrollment :
264 Patients enrolled
Trial Details
Trial ID
NCT03428581
Start Date
April 10 2018
End Date
February 28 2026
Last Update
August 27 2025
Active Locations (2)
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1
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
2
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905