Prospective Assessments Following Immediate Lymphatic Reconstruction

NCT ID: NCT07227467

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2030-12-31

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.(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 Design

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

Study Groups

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

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

patients who are candidates for immediate lymphatic reconstruction

Intervention Type: OTHER

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

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

Facility Contacts

Summer Hanson, MD, PhD, FACS

Role: primary

sehanson@bsd.uchicago.edu

(773) 702-6302

Other Identifiers

IRB25-1329

Identifier Type: -

Identifier Source: org_study_id