Objective Assessment of Outcomes Following Immediate Lymphatic Reconstruction / LYMPHA

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.

Study Overview

• Status: Recruiting
• Conditions: Lymphatic Reconstruction
• Intervention / Treatment: Other: All patients who were candidates for immediate lymphatic reconstruction (ILR)

• Study Type: Observational
• Enrollment (Estimated): 90

Contacts and Locations

• Study Contact: Name: Leila Yazdanbakhsh; Phone Number: 773-834-5087; Email: leila.yazdanbakhsh@bsd.uchicago.edu
• Study Contact Backup: Name: Summer Hanson, MD, PhD, FACS; Phone Number: (773) 702-6302; Email: sehanson@bsd.uchicago.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Recruiting
      • The University o Chicago
      • Contact: Carlisa Dixon; Phone Number: 773-834-4337; Email: cdixon520@bsd.uchicago.edu
      • Contact: Leila Yazdanbakhsh; Phone Number: 773-834-5087; Email: leila.yazdanbakhsh@bsd.uchicago.edu
      • Principal Investigator: Summer Hanson, MD, PhD, FACS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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); All patients who were candidates for immediate lymphatic reconstruction (ILR)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
the impact of ILR on validated patient reported outcome tool using the lymphedema life impact scale (LLIS)	This is an 18 questionnaire that has a scale from 0 (no pain) to 4 (severe pain)	1 Day
the impact of ILR on validated patient reported outcome tool using The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire	This is a 30 questionnaire that has a scale from 1 (No difficulty) to 5 (unable)	1 Day
the impact of ILR on validated patient reported outcome tool using the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES)	This is a 17 questionnaire that scales from unable to do it to not difficult.	1 Day

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Axillary skin swabs of each axilla for microbiome analysis	Characterize the axillary microbiome in limbs that have been treated with ILR compared to those that were unaffected.	1 Day

Collaborators and Investigators

• Sponsor: University of Chicago
• Investigators: Principal Investigator: Summer Hanson, MD, PhD, FACS, University of Chicago

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2024
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): October 1, 2029

Study Registration Dates

• First Submitted: October 14, 2024
• First Submitted That Met QC Criteria: October 18, 2024
• First Posted (Actual): October 21, 2024

Study Record Updates

• Last Update Posted (Actual): February 2, 2026
• Last Update Submitted That Met QC Criteria: January 29, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: IRB24-1513

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No