Actively Recruiting
The N-LVA Study: RCT Comparing LVA vs. Sham Surgery in Cancer-related Lymphedema
Led by Maastricht University Medical Center · Updated on 2026-01-16
110
Participants Needed
3
Research Sites
271 weeks
Total Duration
On this page
Sponsors
M
Maastricht University Medical Center
Lead Sponsor
R
Radboud University Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The N-LVA Study: RCT Comparing LVA vs. Sham Surgery in Cancer-related Lymphedema
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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, diagnosed by lymphoscintigraphy for the lower extremity
- Unilateral lymphedema
- Viable lymphatic vessels as determined by indocyanine green (ICG) lymphography (stage II-III)
- Refractory lymphedema after at least three months of conservative treatment
- Provided informed consent
You will not qualify if you...
- History of lymphatic reconstruction in the past 10 years
- Late-stage lymphedema of the extremity (ISL classification 65 II) with fat deposition and/or fibrosis
- Active distant metastases treated with palliative intent
- Currently receiving active treatment for primary cancer such as surgery, radiotherapy, or chemotherapy (adjuvant targeted or endocrine treatment allowed)
- Edema due to venous insufficiency confirmed by venous duplex ultrasound
- Active infection in the lymphedematous limb
- Bilateral lymphedema
- Lymphedema limited to genital or breast area only
- Primary lymphedema
- Non-viable lymphatic system as determined by ICG lymphography (stages IV and V)
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Radboud University Medical Center
Nijmegen, Gelderland, Netherlands, 6525GA
Actively Recruiting
2
Maastricht University Medical Center
Maastricht, Limburg, Netherlands, 6229HX
Actively Recruiting
3
Erasmus University Medical Center
Rotterdam, South Holland, Netherlands, 3015GD
Actively Recruiting
Research Team
T
Tanya Wolffenbuttel, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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