Objective Assessment of Outcomes Following Immediate Lymphatic Reconstruction / LYMPHA

NCT06650592 | Recruiting

• 1 other identifier: IRB24-1513
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• The efficacy of immediate lymphatic reconstruction (ILR) based on objective circumference

  1 Day

• the efficacy of immediate lymphatic reconstruction (ILR) based on volume

  1 Day

• the efficacy of immediate lymphatic reconstruction (ILR) based on bioimpedance spectroscopy measurements of affected limbs of women in the prophylactic lymphedema database.

  1 Day

• the efficacy of immediate lymphatic reconstruction (ILR) based on unaffected limbs of women in the prophylactic lymphedema database.

  1 Day

Secondary Outcomes (3)

• the impact of ILR on validated patient reported outcome tool using the lymphedema life impact scale (LLIS)

  1 Day

• the impact of ILR on validated patient reported outcome tool using The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire

  1 Day

• the impact of ILR on validated patient reported outcome tool using the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES)

  1 Day

Other Outcomes (1)

• Axillary skin swabs of each axilla for microbiome analysis

  1 Day

Study Arms (1)

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

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

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

Interventions

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

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

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The University of Chicago has a prospectively maintained database (LYMPHA Database) of all patients who were candidates for ILR.

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

The University o Chicago

Chicago, Illinois, 60637, United States

RECRUITING

Study Officials

• Summer Hanson, MD, PhD, FACS

  University of Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Summer Hanson, MD, PhD, FACS

CONTACT

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

Leila Yazdanbakhsh

CONTACT

773-834-5087; leila.yazdanbakhsh@bsd.uchicago.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2024
• First Posted: October 21, 2024
• Study Start: November 26, 2024
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): October 1, 2029
• Last Updated: February 2, 2026

Record last verified: 2026-01

Locations

US (1)