NCT06650592

Objective Assessment of Outcomes Following Immediate Lymphatic Reconstruction / LYMPHA

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 90 (estimated)
• Sponsor: University of Chicago · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

Immediate lymphatic reconstruction (ILR) is a novel surgical approach performed at the time of initial lymph node dissection with the goal of preventing lymphedema. It involves the identification of lymphatic channels that are transected after lymph node dissection and microsurgical anastomosis of one or more lymphatic channel with a local recipient vein to re-direct upper extremity lymphatic drainage. Although ILR carries significant promise in prevention of lymphedema, there is a lack of high-level evidence supporting its efficacy because it is a novel surgical technique that is only offered at a few centers and not routinely covered by insurance carriers yet. The University of Chicago Comprehensive Cancer Center (UCCCC) is one of the busiest microsurgery centers performing this procedure, and, as a Lymphedema Center of Excellence, is in a unique position to investigate the efficacy of ILR in preventing lymphedema. In addition, the University has access to a world class microbiome research facility and colleagues. There is no information on the skin microbiome of the axilla in patients undergoing treatment for breast cancer or those at risk for developing lymphedema. Further exploratory studies such as this in a diverse patient population may lead to practice changing research in our approach to lymphedema management and prevention. The purpose of this study is to determine the role of immediate lymphatic reconstruction and obtain objective data to correlate the existing, self-reported rates of lymphedema at the University of Chicago.

Conditions

• Lymphatic Reconstruction

Interventions

Type	Name	Description
OTHER	All patients who were candidates for immediate lymphatic reconstruction (ILR)	All patients who were candidates for immediate lymphatic reconstruction (ILR)

Timeline

• Start date: 2024-11-26
• Primary completion: 2029-10-01
• Completion: 2029-10-01
• First posted: 2024-10-21
• Last updated: 2026-02-02

Locations

1 site across 1 country: United States