The N-LVA Study: RCT Comparing LVA vs. Sham Surgery in Cancer-related Lymphedema
Effectiveness and Cost-effectiveness of Lymphaticovenous Anastomosis for Cancer Patients Who Suffer From Chronic Peripheral Lymphedema: a Randomized Controlled Trial
Maastricht University Medical Center
110 participants
Dec 18, 2023
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria6
- 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.
Exclusion Criteria10
- 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).
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Interventions
Lymphaticovenous anastomosis (LVA) involves connecting a lymphatic vessel to an adjacent vein of similar size, thereby facilitating the outflow of lymphatic fluid in patients suffering from secondary lymphedema
Sham surgery involves the process of surgery, including local anesthesia and incisions, but no LVA is made.
Locations(3)
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NCT06082349