NCT05970107

Axillary Node Dissection w or w/o LVB in Node Positive Breast Cancer Patients

A Prospective Randomized Trial of Axillary Node Dissection With or Without Lymphaticovenous Bypass (LVB) in Node Positive Breast Cancer Patients

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Lymphedema is a devastating complication of breast cancer surgery that decreases the quality of life of up to 40% of breast cancer survivors. Most lymphedema in breast cancer patients is because lymphatics shared between the axilla and the arm are sacrificed during axillary lymph node dissection (ALND) surgery, which removes an average of 15 lymph nodes in node positive patients. CCF's breast cancer plastic microvascular surgeons and breast surgical oncologists have collaborated to refine a surgical technique known as LVB that may be used either as a preventive measure (prophylactic LVB) or as a therapeutic intervention (therapeutic LVB). Lymphatic reconstruction with LVB may be an improvement to the current standard of care for node positive breast cancer patients undergoing ALND.

Conditions

• Node-positive Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	Axillary Lymph Node Dissection	ALND happens after cancer cells are found during a sentinel lymph node biopsy. ALND can remove lymph nodes located above, below or directly underneath a muscle that runs along the side of the upper chest.
PROCEDURE	Axillary Reverse Mapping	Axillary reverse mapping (ARM) is a technique where blue dye is injected into the upper arm at surgery, allowing direct visualization of arm lymphatics and nodes during ALND
PROCEDURE	Lymphaticovenous Bypass	Lymphaticovenous bypass/anastomosis (LVB/LVA) involves supramicrosurgery in which the blocked lymphatic vessel of an affected limb is connected to a nearby vein with the aid of ultra-fine instruments and a powerful operating microscope.

Timeline

• Start date: 2026-06-01
• Primary completion: 2026-12-01
• Completion: 2028-12-01
• First posted: 2023-08-01
• Last updated: 2026-02-19