The N-LVA Study: RCT Comparing LVA vs. Sham Surgery in Cancer-related Lymphedema

Inclusion Criteria: * 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 Criteria: * 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).