Prospective Assessments Following Immediate Lymphatic Reconstruction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: patients who are candidates for immediate lymphatic reconstruction.
- Who it may be relevant to
- Registry conditions: Lymphatic Reconstruction. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Other patients who are candidates for immediate lymphatic reconstruction
potential candidates for ILR based on possible nodal involvement assessed preoperatively.
Primary outcome measures
- 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.]
- 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.]
- 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.]
Secondary outcome measures (3)
- 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.]
- 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.]
- 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.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- The University o Chicago — Chicago
Identifiers
NCT: NCT07227467 · IRB25-1329