Status:
RECRUITING
The N-LVA Study: RCT Comparing LVA vs. Sham Surgery in Cancer-related Lymphedema
Lead Sponsor:
Maastricht University Medical Center
Collaborating Sponsors:
Radboud University Medical Center
Erasmus Medical Center
Conditions:
Lymphedema, Secondary
Lymphedema of Upper Limb
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 cance...
Detailed Description
One of the most debilitating side effects of cancer treatment is cancer-related lymphedema (CRL), with an overall incidence of 15.5%. To date, there is no definite cure for lymphedema. Conservative th...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
December 18 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2029
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT06082349
Start Date
December 18 2023
End Date
March 1 2029
Last Update
May 16 2024
Active Locations (3)
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1
Radboud University Medical Center
Nijmegen, Gelderland, Netherlands, 6525GA
2
Maastricht University Medical Center
Maastricht, Limburg, Netherlands, 6229HX
3
Erasmus University Medical Center
Rotterdam, South Holland, Netherlands, 3015GD