Outcomes after immediate lymphatic reconstruction
Prospective Assessments Following Immediate Lymphatic Reconstruction
This protocol will follow people having immediate lymphatic reconstruction during lymph node surgery to see if the procedure prevents lymphedema.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Chicago Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT07227467 on ClinicalTrials.gov |
What this trial studies
Immediate lymphatic reconstruction (ILR) is a microsurgical technique performed at the time of lymph node dissection that connects transected lymphatic channels to nearby veins to redirect lymph drainage. This prospective observational protocol at the University of Chicago will enroll patients deemed candidates for ILR and collect standardized clinical and surgical data over time. Follow-up visits will document limb swelling, complications, and functional outcomes to determine real-world rates of post-operative lymphedema. As a single-center effort at a high-volume microsurgery program, the project aims to add systematic outcome data where randomized evidence is currently limited.
Who should consider this trial
Good fit: Ideal candidates are people scheduled for lymph node dissection who are judged preoperatively to be eligible for ILR based on possible nodal involvement.
Not a fit: Patients who are not eligible for ILR based on their preoperative nodal assessment will not be able to participate and therefore will not receive potential benefit from this protocol.
Why it matters
Potential benefit: If successful, ILR could lower the risk of arm lymphedema after lymph node dissection and improve long-term arm function and quality of life.
How similar studies have performed: Early single-center reports, including Chang et al. 2020, report promising reductions in lymphedema with ILR, but randomized and multi-center confirmation is lacking.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Chicago, Illinois
- The University o Chicago — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Summer Hanson, MD, PhD, FACS — University of Chicago
- Study coordinator: Summer Hanson, MD, PhD, FACS
- Email: sehanson@bsd.uchicago.edu
- Phone: (773) 702-6302
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.