Recruiting

Immediate Lymphatic Reconstruction

Sponsor:

University of Chicago

Code:

NCT07227467

Conditions

Lymphatic Reconstruction

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

patients who are candidates for immediate lymphatic reconstruction

Study Details

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.(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.

Conditions

Lymphatic Reconstruction

Study ID

NCT07227467

Start date

Dec 1, 2025

Status verified date

Nov, 2025

Completion date

Dec, 2030

Anticipated

Primary completion date

Dec, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

potential candidates for ILR based on possible nodal involvement assessed preoperatively.

Exclusion Criteria:

  • Individuals who are not eligible for ILR based on possible nodal involvement assessed preoperatively.

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

patients who are potential candidates for immediate lymphatic reconstruction (ILR)

potential candidates for ILR based on possible nodal involvement assessed preoperatively.

Interventions

patients who are candidates for immediate lymphatic reconstruction

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. ]
  • the efficacy of immediate lymphatic reconstruction (ILR) based on volume [ 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. ]
  • the efficacy of immediate lymphatic reconstruction (ILR) based on bioimpedance spectroscopy measurements of affected and unaffected limbs of women before and after surgery. [ 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 and Locations

Central contacts

Summer Hanson, MD, PhD, FACS

(773) 702-6302sehanson@bsd.uchicago.edu

Locations

The University o Chicago

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Summer Hanson, MD, PhD, FACS

(773) 702-6302sehanson@bsd.uchicago.edu

More Information

Sponsor

University of Chicago

Last update posted

Dec 15, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Chicago on 2025-12-15.