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

NCT06082349 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2026-01-16

No results posted yet for this 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.

Conditions

  • Lymphedema, Lower Limb
  • Lymphedema, Secondary
  • Lymphedema of Upper Limb
  • Lymphedema Arm
  • Lymphedema of Leg

Interventions

PROCEDURE

Lymphaticovenous anastomosis

Lymphaticovenous 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

PROCEDURE

Sham surgery

Sham surgery involves the process of surgery, including local anesthesia and incisions, but no LVA is made.

Sponsors & Collaborators

  • Radboud University Medical Center

    collaborator OTHER

  • Erasmus Medical Center

    collaborator OTHER

  • Maastricht University Medical Center

    lead OTHER

Principal Investigators

  • Shan Shan Qiu Shao, MSc, PhD · Maastricht University Medical Center

  • Stefan Hummelink, MSc, PhD · Radboud University Medical Center

  • Dalibor Vasilic, MSc, PhD · Erasmus Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-18
Primary Completion
2029-03-01
Completion
2029-03-01

Countries

  • Netherlands

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06082349 on ClinicalTrials.gov