The N-LVA Study: RCT Comparing LVA vs. Sham Surgery in Cancer-related Lymphedema
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Lymphedema, Secondary, Lymphedema of Upper Limb, Lymphedema, Lower Limb, Lymphedema Arm, Lymphedema of Leg
In brief
The goal of this randomized controlled trial is to compare the effectiveness and cost-effectiveness of lymphaticovenous anastomosis (LVA) with sham surgery for patients suffering from unilateral cancer-related lymphedema in either the upper or lower extremity. It aims to answer whether LVA is more effective than sham surgery in terms of improvement in Lymph-ICF score. A total of 110 participants will be allocated randomly into two groups at a 1:1 ratio. The first group will receive lymphaticovenous anastomosis (LVA), while the second group will undergo sham surgery.
Key facts
- Study ID
- NCT06082349
- Run by
- Maastricht University Medical Center
- People needed
- 110
- Starts
- 2023-12-18
- Expected to finish
- 2029-03-01
- Last updated by the study team
- 2026-01-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Treated for cancer and underwent treatment of either axillary or inguinal lymph nodes or radiotherapy;
- Early stage lymphedema (ISL I-II) in the upper or lower extremity, and diagnosed by lymphoscintigraphy for the lower extremity;
- Unilateral lymphedema;
- Viable lymphatic vessels as determined by indocyanine green (ICG)Lymphography (stage II-III);
- Refractory lymphedema that underwent at least three months of conservative treatment;
- Informed consent.
You may not qualify if…
- History of lymphatic reconstruction in the past 10 years;
- Late-stage lymphedema of the extremity (ISL classification ≥ II lymphedema) with evident fat deposition and/or fibrosis;
- Patients with active distant metastases, treated with palliative intent;
- Patients with the active treatment of primary cancer, i.e. surgery, radiotherapy, and/or chemotherapy. Note: patients receiving adjuvant targeted and/or endocrine treatment are eligible;
- Edema due to venous insufficiency, evaluated by venous duplex ultrasound of the deep and superficial venous system;
- Active infection in the lymphedematous extremity;
- Bilateral lymphedema;
- Lymphedema present in genital or breast area only;
- Primary lymphedema;
- Non-viable lymphatic system as determined by ICG Lymphography (stages IV and V).
Where it is running
- Radboud University Medical Center — Nijmegen, Gelderland, Netherlands (enrolling)
- Maastricht University Medical Center — Maastricht, Limburg, Netherlands (enrolling)
- Erasmus University Medical Center — Rotterdam, South Holland, Netherlands (enrolling)
Full record on ClinicalTrials.gov
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