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.
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);
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;
Parallel
Lymphaticovenous anastomosis
Procedure/SurgeryLymphaticovenous 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
Procedure/SurgerySham surgery involves the process of surgery, including local anesthesia and incisions, but no LVA is made.
Change from baseline in the Lymph-ICF Score at 12 and 24 months
The Dutch version of the 'Lymphedema Functioning, Disability, and Health" (Lymph-ICF) questionnaire is used. There are two versions of the Lymph-ICF; one for the upper extremity and one for the lower extremity. The questionnaires assess the impairments in function, activity limitations, and participation restrictions of patients with lymphedema. It is a validated, disease-specific questionnaire, consisting of items across 5 domains. Each item is scored on a VAS, ranging from 0 to 100.
Change from baseline in excess limb volume
The excess limb volume will be measured with BioImpedance Spectroscopy (BIS). With a bioimpedance device, the volume of the extremities can be measured together with the fluid in different compartments of the extremities.
Change from baseline in extremity circumference measured by the Upper and Lower Extremity Lymphedema (UEL and LEL) indices
The extremity circumference will be measured using measuring tape according to the fixed measuring points of the UEL- and LEL-indices. The UEL- and LEL-indices are corrected for BMI.
Change from baseline in the use of conservative treatment
Discontinuation of conservative treatment, being complex decongestive therapy, will be assessed with a patient diary to record the frequency of treatments received (i.e. skin therapy visits, number of compression garments, etc.).
Postoperative complications
All postoperative complications for both treatment groups will be recorded to monitor safety. SAEs will be directly reported to the sponsor.
Click on the lead sponsor to view all of their trials.
Maastricht University Medical Center
Lead sponsor
Radboud University Medical Center
Collaborator
Erasmus Medical Center
Collaborator
