Effect of Lymphovenous Anastomosis on Lower Limb Lymphedema: Pragmatic Randomized Controlled Trial

NCT07073586 · tracked via the Priya Life Science Denmark tracker

Sponsor

Herlev and Gentofte Hospital

Phase

Not applicable

Started

2025-05-09

Last updated

2025-07-31

Condition(s) studied

LymphedemaLymphoedemaLymphoedema of LegLymphedema of Leg

Investigational drug(s) / intervention(s)

Lymphovenous AnastomosisComplete Decongestive Therapy

Lymphovenous Anastomosis: Microsurgical creation of multiple lymphatic-venous connections in the most affected limb under general anaesthesia.

Complete Decongestive Therapy: Complete Decongestive Therapy, comprising bandaging, skin care and exercise, followed by compression garments.

Study summary

This multicentre pragmatic randomised controlled trial evaluates lymphovenous anastomosis (LVA) for lower-limb lymphedema (LLL) in Denmark. Adults with unilateral or bilateral International Society of Lymphology (ISL) stage 1-2a LLL who have completed protocol-defined Complete Decongestive Therapy (CDT) are randomised 1:1 to

Intervention arm - LVA surgery plus ongoing compression care

Control arm - Compression care only

Recruitment takes place at the Departments of Plastic Surgery, Herlev-Gentofte Hospital and Odense University Hospital. Outcomes are assessed by independent blinded staff at baseline, 6, 12 and 24 months. A biopsy substudy in ten LVA patients explores inflammatory and fibrotic changes. Primary endpoint is change in L-Dex ratio at 12 months. Secondary endpoints include limb volume, infection rate, lymphoscintigraphy findings, patient-reported outcomes, compression-garment use and anastomosis patency.

The trial follows Good Clinical Practice and General Data Protection Regulation (GDPR). Patients are covered by the Danish public patient-compensation scheme. Results will be published regardless of outcome, and control participants may opt for LVA after the 12-month visit.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * LLL International Society of Lymphology (ISL) stage 1-2a (both primary and secondary lymphedema and both unilateral and bilateral) * Cancer-free with no recurrence for at least one year * Age 18 or above * Circumference of the affected leg is at least 1 cm larger than the non-lymphedema leg at the most affected site of lymphedema. * Proficiency in Danish language, and ability to provide informed consent. * Dermal Backflow Stage 0-4 Exclusion Criteria: * LLL International Society of Lymphology (ISL) stage 2b-3 * Medical conditions contraindicating surgical intervention or anesthesia, such as severe heart or lung disease * Allergy to ICG * Ongoing infections or skin diseases in the affected limb * Previous surgery or other treatment modalities that could interfere with the study results (previous LVA, liposuction or similar). * Dermal Backflow Stage 5 * Active cancer * Heart or kidney conditions that can cause leg swelling * A BMI above 28 kg/m² * Current smoker * Any foreign objects in the lower extremities (e.g., metal implants, prostheses) * Venous insufficiency Unilateral weakness in the lower extremity (e.g., after a stroke) * Known iodine allergy (contraindication for ICG injection) * Leg length discrepancy (anisomelia) \> 1.5 cm

Primary outcome measure(s)

Change in L-Dex ratio (bioimpedance spectroscopy) at 12 months. — Baseline to 12 months
Difference in L-Dex ratio of the most affected leg, measured with the SOZO bioimpedance device (ImpediMed). Measurements are performed by blinded assessors after 48 h without compression garments.

Trial sites (2)

Facility	City	Region	Status
Department of Plastic Surgery, Odense University Hospital	Odense	Fyn	Not Yet Recruiting
Department of Plastic Surgery, Herlev and Gentofte Hospital	Herlev	Region Sjælland	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07073586 on ClinicalTrials.gov ↗ ← All trials in Denmark