Objective Assessment of Outcomes Following Immediate Lymphatic Reconstruction / LYMPHA

NCT ID: NCT06650592

Last Updated: 2026-02-02

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 90 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-11-26
• Study Completion Date: 2029-10-31

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 Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

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

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

Intervention Type: OTHER

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

Interventions

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

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• None

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Summer Hanson, MD, PhD, FACS

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

The University o Chicago

Chicago, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Summer Hanson, MD, PhD, FACS

Role: CONTACT

sehanson@bsd.uchicago.edu

(773) 702-6302

Leila Yazdanbakhsh

Role: CONTACT

leila.yazdanbakhsh@bsd.uchicago.edu

773-834-5087

Facility Contacts

Leila Yazdanbakhsh

Role: primary

leila.yazdanbakhsh@bsd.uchicago.edu

773-834-5087

Carlisa Dixon

Role: backup

cdixon520@bsd.uchicago.edu

773-834-4337

Other Identifiers

IRB24-1513

Identifier Type: -

Identifier Source: org_study_id