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NCT Number: NCT06650592

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.

Recruiting

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

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

Other

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

Primary outcomes

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

    Time frame: 1 Day

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

    Time frame: 1 Day

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

    Time frame: 1 Day

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

    Time frame: 1 Day

Secondary outcomes

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

    Time frame: 1 Day

    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: 1 Day

    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: 1 Day

    This is a 17 questionnaire that scales from unable to do it to not difficult.

Other outcomes

  1. Axillary skin swabs of each axilla for microbiome analysis

    Time frame: 1 Day

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

Study contacts

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

Leila Yazdanbakhsh

CONTACT

[email protected]

773-834-5087

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
2024
Primary completion
2029
Study completion
2029
First posted
Oct 21, 2024
Registry last updated
Feb 2, 2026

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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