Preventing Lymphedema in Patients Undergoing Axillary Lymph Node Dissection Via Axillary Reverse Mapping and Lympho-venous Bypass
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Mayo Clinic
- Enrollment
- 264
- Locations
- 2
- Primary Endpoint
- Less frequently reported symptoms of lymphedema in the study extremity compared to baseline and the control extremity
Study Overview
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-operative lymphedema of the arm.
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 without this technique. As a baseline, all subjects will have the circumference of their arms measured and complete a questionnaire about lymphedema. Performing the measurements and answering a questionnaire will be repeated at 6, 12, 24, and 36 months after surgery.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
ALND with ARM +/- LVB
Axillary Lymph Node Dissection (ALND) using Axillary Reverse Mapping (ARM) with Lympho-venous bypass (LVB) will be performed.
Intervention: ALND with ARM +/- LVB (Procedure)
ALND without ARM +/- LVB
Axillary Lymph Node Dissection (ALND)
Intervention: ALND (Procedure)
Outcomes
Primary Outcomes
Less frequently reported symptoms of lymphedema in the study extremity compared to baseline and the control extremity
Time Frame: 36 months following surgery
Validated patient reported surveys
Less than 5% limb volume increase in the study extremity compared to baseline and the control extremity
Time Frame: 36 months following surgery
Bilateral Limb volume measurements
Secondary Outcomes
No secondary outcomes reported
Investigators
James W. Jakub
Principal Investigator
Mayo Clinic