Edema
Conditions
Interventions
Adult patients with refractory, cancer-related lymphedema in the upper or lower 
extremity, who are eligible for surgery, will be randomly allocated to one of 
the two treatment groups: 
1. LVA group
 
2. Sham group. 
Group 1. Lymphaticovenous anastomosis (LVA): 
LVA involves anastomosing lymphatic vessels (0.3 to 0.5 millimetres in 
diameter) to small veins in the subdermal plane to bypass obstructions of the 
lymphatic transport. The surgical technique follows the technique of other 
international surgeons. 
Before the start of the surgery, the patient will be blinded with 
noise-cancelling headphones and blindfolds. Then the patient lies comfortably 
on the operation table, after which the affected limb is prepared for surgery. 
A limb table is used. Before marking the incision, a mix of bupivacaine 
(Marcaïne®) and epinephrine (1:100.000) is injected at the site of the incision 
to achieve local anaesthesia and optimal hemostasis. Based on the ICG 
lymphangiography mapping, incisions of 1, 5 to 2 cm are made at the 
predetermined sites. The incisions are made at the level where the lymphatic 
vessels are obstructed to prevent any damage to the viable part of the 
Sponsors
Maastricht Universitair Medisch Centrum +
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - 18 years old or older; - Treated for cancer; - 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) (23); - Refractory lymphedema that underwent at least three months of conservative treatment; - Informed consent.
Exclusion criteria
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint will be the change in Lymph-ICF score at 12 and 24 months follow-up. To assess the effectiveness of the treatment we will use the Dutch version of the *Lymphedema Functioning, Disability, and Health* (Lymph-ICF) questionnaire. This questionnaire assesses the impairments in function, activity limitations, and participation restrictions of patients with lymphedema. It is a validated, disease-specific questionnaire, consisting of items (questions) across 5 domains. Each item is scored on a VAS, ranging from 0 to 100. The total score on the Lymph-ICF is equal to the sum of the item scores, divided by the total number of answered items. A higher score on the Lymph-ICF indicates more problems with functioning related to lymphedema. For the upper limb a decrease of 11 points represents a statistically significant difference and a decrease of 15 points indicates a clinically relevant difference. The 15-point cut-off was used for this sample size calculation. For lower limb lymphedema a decrease of 20 points or more in total score and each domain separately (except life and social life domain score) are considered clinically relevant. For the life and social life domain score, a difference of 40 points is considered clinically relevant. The 20 points cut-off point was used for the sample size calculation for the lower limb. HRQoL will be assessed at inclusion and 3, 6, 12, and 24 months after randomization. | — |
Secondary
| Measure | Time frame |
|---|---|
| - The excess limb volume; - The extremity circumference; - Discontinuation of conservative treatment; - Postoperative complications; - Patency of the LVA; - Patient costs, QALYs, and incremental cost-effectiveness. | — |
Countries
Netherlands
Contacts
Public ContactT Wolffenbuttel
Maastricht Universitair Medisch Centrum +
Outcome results
None listed