Prospective Assessments Following Immediate Lymphatic Reconstruction

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Chicago

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • patients who are candidates for immediate lymphatic reconstruction

    Other intervention

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

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: patients who are potential candidates for immediate lymphatic reconstruction (ILR)1 intervention

Trial outcomes

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.

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

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.

Secondary outcomes

1

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)

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 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)

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

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

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.

Other outcomes

1

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

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.