Prospective Assessments Following Immediate Lymphatic Reconstruction

NCT07227467 | Recruiting

• 1 other identifier: IRB25-1329
• Study Type: observational
• Target: 100
• 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.(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

Outcome Measures

Primary Outcomes (3)

• The efficacy of immediate lymphatic reconstruction (ILR) based on limb circumference of each arm

  post operative study period at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 48 months and 60 months.

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

  post operative study period at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 48 months and 60 months.

• the efficacy of immediate lymphatic reconstruction (ILR) based on bioimpedance spectroscopy measurements of affected and unaffected limbs of women before and after surgery.

  Bioimpedance spectroscopy is a non-invasive technology that measures total body water, and both extracellular and intracellular fluid volumes.

  post operative study period at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 48 months and 60 months.

Secondary Outcomes (3)

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

  post operative study period at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 48 months and 60 months.

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

  post operative study period at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 48 months and 60 months.

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

  post operative study period at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 48 months and 60 months.

Other Outcomes (1)

• Comparison of the Axillary Microbiome in ILR-Treated and Untreated Limbs

  post operative study period at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 48 months and 60 months.

Study Arms (1)

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

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

Other: patients who are candidates for immediate lymphatic reconstruction

Interventions

patients who are candidates for immediate lymphatic reconstruction OTHER

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Individuals who are not eligible for ILR based on possible nodal involvement assessed preoperatively.

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

Study Design

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

Study Record Dates

• First Submitted: November 6, 2025
• First Posted: November 12, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: December 15, 2025

Record last verified: 2025-11

Locations

US (1)