Lymphovenous Anastomosis for Breast Cancer Lymphedema

Condition(s) studied

Investigational drug(s) / intervention(s)

Lymphovenous anastomosis (LVA): Surgical procedure with supermicrosurgical anastomosis between distal lymph vessel and proximal venule.

Study 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.

Eligibility

Primary outcome measure(s)

• Arm volume (Water Displacement) — Baseline, six months, twelve months
  Changes of arm volume difference
• Arm volume (Arm Circumferences) — Baseline, six months, twelve months
  Changes of arm volume difference

Trial sites (1)

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