NCT05366699

LYMPHA Procedure for the Prevention of Lymphedema After Axillary Lymphadenectomy

A Randomized Clinical Trial of the LYMPHA Procedure for the Prevention of Lymphedema After Axillary Lymphadenectomy

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Stanford University · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Lymphedema is a chronic, progressive, and debilitating condition that occurs with disruption or obstruction of the lymphatic system, which commonly occurs a result of breast cancer therapy. The purpose of this study is to determine if the use of a low risk lymphatic reconstruction procedure at the time of axillary lymph node dissection will reduce the risk of developing lymphedema. Additionally, to determine if this procedure improves objective outcomes of lymphedema and patient quality of life

Conditions

• Lymphedema, Breast Cancer
• Lymphedema

Interventions

Type	Name	Description
PROCEDURE	axillary lymphadenectomy with immediate lymphatic reconstruction (LYMPHA)	lymphatic reconstruction where the cut lymphatic vessels are reconstructed by anastamosing to the veins
PROCEDURE	Axillary lymphadenetomy alone	oncologic axillary lymphadenectomy
PROCEDURE	axillary lymphadenectomy with soft tissue reinforcement	axillary lymphadenectomy with soft tissue reinforcement(STR)

Timeline

• Start date: 2021-09-10
• Primary completion: 2026-06-01
• Completion: 2030-06-01
• First posted: 2022-05-09
• Last updated: 2025-12-29

Locations

1 site across 1 country: United States