Breast Cancer, Lymphedema, Melanoma
Conditions
Keywords
Axillary, Lymph node, Dissection, Reverse Mapping, Lympho-venous Bypass (LVB), Axillary Reverse Mapping (ARM)
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.
Interventions
PROCEDUREALND with ARM +/- LVB
Subjects will undergo removal of the lymph nodes in the underarm or "axilla" area. This is referred to as an axillary lymph node dissection (ALND). The procedure for identifying the drainage of the arm lymphatics during an axillary dissection has been coined axillary reverse mapping (ARM). Lympho-venous bypass (LVB) is a technique incorporated along with the ARM procedure that allows preservation of the lymphatics draining the arm while removing the standard lymph nodes and not compromising the extent of the axillary dissection.
PROCEDUREALND
Prospective and retrospective subjects undergoing an ALND.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Less than 5% limb volume increase in the study extremity compared to baseline and the control extremity | 36 months following surgery | Bilateral Limb volume measurements |
| Less frequently reported symptoms of lymphedema in the study extremity compared to baseline and the control extremity | 36 months following surgery | Validated patient reported surveys |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJames W Jakub, MD
Mayo Clinic
PRINCIPAL_INVESTIGATORMara A. Piltin, DO
Mayo Clinic in Rochester
Outcome results
None listed