Recruiting

Lymphatic Reconstruction

Sponsor:

University of Chicago

Code:

NCT06650592

Conditions

Lymphatic Reconstruction

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Interventions

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

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. 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

Study ID

NCT06650592

Start date

Nov 26, 2024

Status verified date

Jan, 2026

Completion date

Oct, 2029

Anticipated

Primary completion date

Oct, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Design

Enrollment

90 participants

Anticipated

Interventions and Outcome Measures

Arms

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

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

Interventions

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

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

The University o Chicago

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Principal Investigator:

Summer Hanson, MD, PhD, FACS

More Information

Sponsor

University of Chicago

Last update posted

Feb 2, 2026

Last verified

Jan, 2026

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 2026-02-02.