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

Last updated: May 14, 2024
Sponsor: Maastricht University Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lymphedema

Treatment

Lymphaticovenous anastomosis

Sham surgery

Clinical Study ID

NCT06082349
NL84169.068.23
2021038374
METC23-023
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Treated for cancer and underwent treatment of either axillary or inguinal lymphnodes or radiotherapy;

  • Early stage lymphedema (ISL I-II) in the upper or lower extremity, and diagnosed bylymphoscintigraphy for the lower extremity;

  • Unilateral lymphedema;

  • Viable lymphatic vessels as determined by indocyanine green (ICG)Lymphography (stageII-III);

  • Refractory lymphedema that underwent at least three months of conservativetreatment;

  • Informed consent.

Exclusion

Exclusion Criteria:

  • History of lymphatic reconstruction in the past 10 years;

  • Late-stage lymphedema of the extremity (ISL classification ≥ II lymphedema) withevident 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 endocrinetreatment are eligible;

  • Edema due to venous insufficiency, evaluated by venous duplex ultrasound of the deepand 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).

Study Design

Total Participants: 110
Treatment Group(s): 2
Primary Treatment: Lymphaticovenous anastomosis
Phase:
Study Start date:
December 18, 2023
Estimated Completion Date:
March 01, 2029

Study 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 therapy, namely complex decongestive therapy is the golden standard for the treatment. Lymphaticovenous anastomosis (LVA) might be a promising treatment modality for patients with CRL, but available studies are small and the quality is lacking. No large-scale prospective or randomized studies have been published on the efficacy of LVA.

The main objective of this randomized controlled trial is to assess whether LVA is more effective than sham surgery in terms of improvement in Lymph-ICF score, volume reduction, reduction of complex decongestive therapy, and cost-effectiveness.

The study will take place in three centers in the Netherlands: Maastricht University Medical Center, Radboud University Medical Center, and Erasmus University Medical Center.

The patients will be randomly distributed into two groups: the LVA group or the Sham group. Both procedures are performed under local anesthesia. Patients in both groups are subject to minor surgical complications (wound infection, bleeding, wound dehiscence). Special care will be taken to prevent damage to lymphatic vessels in the Sham group, to allow a future LVA operation once the study ends. The follow-up moments will be at 3, 6, 12, 18, and 24 months. Additionally, a subset of patients will partake in an annual extended follow-up, ongoing until the start of the analysis. Each follow-up moment will last 45 minutes in total. The patient also receives two digital questionnaires at each follow-up moment.

Connect with a study center

  • Radboud University Medical Center

    Nijmegen, Gelderland 6525GA
    Netherlands

    Active - Recruiting

  • Maastricht University Medical Center

    Maastricht, Limburg 6229HX
    Netherlands

    Active - Recruiting

  • Erasmus University Medical Center

    Rotterdam, Zuid-Holland 3015GD
    Netherlands

    Site Not Available

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