NCT07026292

Supermicrosurgical Lymphaticovenous Anastomosis for Prevention of Upper Limb Lymphedema

A Phase Ⅲ, Multicenter, Prospective, Open-Label, Controlled Study of Supermicrosurgical Lymphaticovenous Anastomosis for Prevention of Upper Limb Lymphedema in Breast Cancer Patients Following Axillary Lymph Node Dissection and Adjuvant Radiotherapy

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Breast cancer-related lymphedema (BCRL) is one of the most common chronic complications following breast cancer treatment. This study enrolls breast cancer patients who are required to undergo axillary lymph node dissection and postoperative adjuvant radiotherapy. Based on patients' preferences, they will be assigned to receive either immediate distal lymphaticovenous anastomosis (ID-LVA) following axillary lymph node dissection (experimental group) or not (control group). The study aims to evaluate the safety and efficacy of ID-LVA in preventing breast cancer-related upper limb lymphedema.

Conditions

• Breast Cancer-Related Lymphedema
• Lymphedema
• Breast Cancer Invasive

Interventions

Type	Name	Description
PROCEDURE	Immediate Distal Lymphaticovenous Anastomosis (ID-LVA)	ID-LVA (Immediate Distal Lymphaticovenous Anastomosis) is an supermicrosurgical technique performed during axillary lymph node dissection (ALND) to prevent breast cancer-related lymphedema, offering the dual advantages of immediate intervention and radiation-field avoidance. Compared to LYMPHA (Lymphatic Microsurgical Preventive Healing Approach), which utilizes proximal axillary anastomoses within the radiation field with larger vessels and higher venous pressure, ID-LVA creates precise anastomoses between 0.3-0.8mm distal superficial lymphatic vessels and low-pressure venules in the upper arm. In contrast to DD-LVA (Delayed Distal Lymphaticovenous Anastomosis) performed postoperatively (typically 4-12 weeks after ALND) for subclinical lymphedema, ID-LVA provides earlier prevention by utilizing undamaged lymphatics and avoids the need for a second procedure.

Timeline

• Start date: 2025-07-01
• Primary completion: 2027-05-31
• Completion: 2029-05-31
• First posted: 2025-06-18
• Last updated: 2025-06-18