Lymphovenous Anastomosis for Breast Cancer Lymphedema

Summary

This multi-center cohort study focuses on evaluating the efficacy of lymphovenous anastomosis (LVA) for treating pitting lymphedema in female breast cancer survivors. Conducted across multiple centers in Denmark, including Odense University Hospital, Herlev Hospital, Lillebaelt Hospital Vejle, and Zealand University Hospital, it aims to assess LVA's impact on reducing arm volume and improving quality of life in patients with upper extremity lymphedema secondary to breast cancer treatment.

Eligible participants are adult women with unilateral arm lymphedema who show active pitting and identifiable lymphatic vessels via indocyanine green lymphography. Inclusion involves informed consent and the ability to complete Danish questionnaires.

Patients are recruited from the outpatient clinics of the participating hospitals and will undergo LVA surgery under either local or general anesthesia. Following the intervention, patients are seen for data collection up to twelve months.

The study measures outcomes like arm volume changes through water displacement volumetry and arm circumferential measurements, body composition via bioimpedance, health-related quality of life through LYMPH-Q, general quality of life through SF-36, arm function via DASH, and anastomosis patency via ICG lymphography. Additionally, changes in ICG lymphography images, arm fibrosis via SkinFibroMeter, and surgery duration are evaluated.

The study adheres to ethical guidelines, ensuring patient safety and the integrity of the research.

Conditions

• Lymphedema
• Lymphedema Arm
• Breast Cancer Lymphedema
• Lymphedema, Secondary
• Lymphedema; Surgical
• Lymphedema of Upper Limb
• Lymphedema, Breast Cancer

Interventions

PROCEDURE

Lymphovenous anastomosis (LVA)

Surgical procedure with supermicrosurgical anastomosis between distal lymph vessel and proximal venule.

Sponsors & Collaborators

• Vejle Hospital

  collaborator OTHER

• Zealand University Hospital

  collaborator OTHER

• Herlev and Gentofte Hospital

  collaborator OTHER

• Odense University Hospital

  lead OTHER

Principal Investigators

• Caroline Lilja, MD · Odense University Hospital

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-03-01

Primary Completion

2026-06-30

Completion

2026-06-30

Countries

• Denmark

Study Locations