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NCT Number: NCT07227467

Prospective Assessments Following Immediate Lymphatic Reconstruction

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The University o Chicago

Chicago, Illinois, 60637, United States

Location status: Recruiting

Location contact

Summer Hanson, MD, PhD, FACS

CONTACT

[email protected]

(773) 702-6302

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

patients who are candidates for immediate lymphatic reconstruction

Other

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

Primary outcomes

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

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

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

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

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

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

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

Secondary outcomes

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

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

    This is an 18 questionnaire that has a scale from 0 (no pain) to 4 (severe pain)

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

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

    This is a 30 questionnaire that has a scale from 1 (No difficulty) to 5 (unable)

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

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

    This is a 10 questionnaire that scales from unable to do it (1) to not difficult (3).

Other outcomes

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

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

    Characterize the axillary microbiome in limbs that have been treated with ILR compared to those that were unaffected before and after surgery.

Study contacts

Contact information is provided by the study sponsor or research team.

Summer Hanson, MD, PhD, FACS

CONTACT

[email protected]

(773) 702-6302

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Nov 12, 2025
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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