Objective Assessment of Outcomes Following Immediate Lymphatic Reconstruction / LYMPHA

NCT06650592 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 90

Last updated 2026-02-02

No results posted yet for this study

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

OTHER

All patients who were candidates for immediate lymphatic reconstruction (ILR)

All patients who were candidates for immediate lymphatic reconstruction (ILR)

Sponsors & Collaborators

  • University of Chicago

    lead OTHER

Principal Investigators

  • Summer Hanson, MD, PhD, FACS · University of Chicago

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-26
Primary Completion
2029-10-31
Completion
2029-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06650592 on ClinicalTrials.gov