Objective Assessment of Outcomes Following Immediate Lymphatic Reconstruction / LYMPHA

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Chicago
Study ID
NCT06650592
Status
Recruiting
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Conditions

  • Lymphatic Reconstruction

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Nov 26, 2024
Status verified
Jan 2026
Primary completion
Oct 31, 2029
Completion
Oct 31, 2029

Study Design

Enrollment
90 participants (estimated)

Arms

  • Arm: All patients who were candidates for immediate lymphatic reconstruction (ILR)
    All patients who were candidates for immediate lymphatic reconstruction (ILR) in the LYMPHA Database

Primary Outcome Measure

The efficacy of immediate lymphatic reconstruction (ILR) based on objective circumference [ Time Frame: 1 Day ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University o ChicagoChicagoIllinois60637
Leila Yazdanbakhsh
[email protected]
773-834-5087
Carlisa Dixon
[email protected]
773-834-4337
Summer Hanson, MD, PhD, FACS (PRINCIPAL_INVESTIGATOR)

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