Prospective Assessments Following Immediate Lymphatic Reconstruction

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Chicago
Study ID
NCT07227467
Status
Recruiting
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Conditions

  • Lymphatic Reconstruction

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • patients who are candidates for immediate lymphatic reconstruction — OTHER
    potential candidates for ILR based on possible nodal involvement assessed preoperatively.

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.(Chang et al. 2020) 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. To our knowledge, 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.

Key Dates

Start date
Dec 1, 2025
Status verified
Nov 2025
Primary completion
Dec 31, 2030
Completion
Dec 31, 2030

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: patients who are potential candidates for immediate lymphatic reconstruction (ILR)
    potential candidates for ILR based on possible nodal involvement assessed preoperatively.

Primary Outcome Measure

The efficacy of immediate lymphatic reconstruction (ILR) based on limb circumference of each arm [ Time Frame: post operative study period at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 48 months and 60 months. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University o ChicagoChicagoIllinois60637
Summer Hanson, MD, PhD, FACS
[email protected]
(773) 702-6302

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By research site
The University o Chicago· Chicago, IL

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