Trials / Terminated
TerminatedNCT03428581
Preventing Lymphedema in Axillary Lymph Node Dissection
Preventing Lymphedema in Patients Undergoing Axillary Lymph Node Dissection Via Axillary Reverse Mapping and Lympho-venous Bypass
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 264 (actual)
- Sponsor
- Mayo Clinic · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | ALND 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. |
| PROCEDURE | ALND | Prospective and retrospective subjects undergoing an ALND. |
Timeline
- Start date
- 2018-04-10
- Primary completion
- 2025-07-11
- Completion
- 2025-07-11
- First posted
- 2018-02-09
- Last updated
- 2026-02-24
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT03428581. Inclusion in this directory is not an endorsement.