Surgical Technique for Preventing Lymphedema After Breast Cancer Surgery

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byMara Piltin, DO

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Mayo Clinic

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for English-speaking patients at high risk of needing axillary lymph node dissection (ALND) as judged by their surgeon. It's not for those who've had radiation in the same armpit area, only need a sentinel lymph node biopsy, have been treated or are being treated to prevent arm lymphedema, or are pregnant.

Inclusion Criteria

I speak English.

My surgeon thinks I might need a more extensive lymph node surgery based on what is found during surgery.

I am scheduled for surgery to remove lymph nodes under my arm.

Exclusion Criteria

I am having a minor lymph node surgery or my doctor thinks it's unlikely I'll need a more extensive one.

I have been treated or am being treated to prevent swelling in my arm(s).

I have had radiation therapy on the same side as my underarm before.

+2 more

Participant Groups

The study aims to see if adding axillary reverse mapping (ARM) and lympho-venous bypass (LVB) when performing ALND can reduce the chances and severity of developing arm lymphedema after surgery in breast cancer and melanoma patients.

2Treatment groups

Experimental Treatment

Active Control

Group I: ALND with ARM +/- LVBExperimental Treatment1 Intervention

Axillary Lymph Node Dissection (ALND) using Axillary Reverse Mapping (ARM) with Lympho-venous bypass (LVB) will be performed.

Group II: ALND without ARM +/- LVBActive Control1 Intervention

Axillary Lymph Node Dissection (ALND)