Trials / Recruiting
RecruitingNCT06989099
Lymphedema Prevention Through Immediate Lymphatic Reconstruction (LILY) Trial.
Lymphedema Prevention Through Immediate Lymphatic Reconstruction (LILY) Trial
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- Sponsor
- M.D. Anderson Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To learn if reconstruction of the lymphatic system at the time of axillary lymphadenectomy can reduce the risk of developing lymphedema.
Detailed description
Primary Objectives \- To determine the freedom from lymphedema (FFL) rate at 2 years postoperatively in participants with a diagnosis of IBC undergoing ILR at the time of ALND. Secondary Objectives * Estimate the proportion of participants who have lymphedema that persists at 2 years after ILR surgeries. * Determine baseline lymphatic vessel anatomical or functional characteristics associated with increased risk of lymphedema following ILR. * Evaluate changes in systemic inflammatory mediators and systemic immune cell function affiliated with lymphedema development.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Immediate Lymphatic Reconstruction (ILR)/ | Given by Procedure |
| PROCEDURE | Prophylactic Lymphovenous Bypass (pLVB) | Given by Procedure |
Timeline
- Start date
- 2024-09-24
- Primary completion
- 2028-08-01
- Completion
- 2029-08-01
- First posted
- 2025-05-25
- Last updated
- 2026-02-19
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06989099. Inclusion in this directory is not an endorsement.