Objective Assessment of Outcomes Following Immediate Lymphatic Reconstruction / LYMPHA

Recruiting

• Conditions: Lymphatic Reconstruction

• Registration Number: NCT06650592
• Lead Sponsor: University of Chicago

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-14
• Study First Submitted QC: 2024-10-18
• Study First Posted: 2024-10-21
• Study Start: 2024-11-26
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-10
• Last Update Posted: 2025-01-14
• Primary Completion: 2029-10
• Study Completion: 2029-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• All patients who were candidates for Immediate Lymphatic Reconstruction (ILR)

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The efficacy of immediate lymphatic reconstruction (ILR) based on objective circumference	1 Day
the efficacy of immediate lymphatic reconstruction (ILR) based on volume	1 Day
the efficacy of immediate lymphatic reconstruction (ILR) based on bioimpedance spectroscopy measurements of affected limbs of women in the prophylactic lymphedema database.	1 Day
the efficacy of immediate lymphatic reconstruction (ILR) based on unaffected limbs of women in the prophylactic lymphedema database.	1 Day

Secondary Outcome Measures

Name	Time	Method
the impact of ILR on validated patient reported outcome tool using the lymphedema life impact scale (LLIS)	1 Day	This is an 18 questionnaire that has a scale from 0 (no pain) to 4 (severe pain)
the impact of ILR on validated patient reported outcome tool using The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire	1 Day	This is a 30 questionnaire that has a scale from 1 (No difficulty) to 5 (unable)
the impact of ILR on validated patient reported outcome tool using the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES)	1 Day	This is a 17 questionnaire that scales from unable to do it to not difficult.

Trial Locations

Locations (1)

The University o Chicago; 🇺🇸 Chicago, Illinois, United States