Lymphovenous Anastomosis for Breast Cancer Lymphedema

NCT06302361 | Active Not Recruiting

• 1 other identifier: 23/54225
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Arm volume (Water Displacement)

  Changes of arm volume difference

  Baseline, six months, twelve months

• Arm volume (Arm Circumferences)

  Changes of arm volume difference

  Baseline, six months, twelve months

Secondary Outcomes (9)

• Health-related quality of life (LYMPH-Q)

  baseline, three months, six months, nine months, twelve months

• General quality of life (SF-36)

  baseline, three months, six months, nine months, twelve months

• Arm and shoulder function (DASH)

  baseline, three months, six months, nine months, twelve months

• L-Dex

  Baseline, six months, twelve months

• LVA patency

  Baseline, six months

Study Arms (1)

Lymphovenous anastomosis (LVA)

EXPERIMENTAL

Intervention with lymphovenous anastomosis (LVA) surgery of the affected arm.

Procedure: Lymphovenous anastomosis (LVA)

Interventions

Lymphovenous anastomosis (LVA) PROCEDURE

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

Also known as: Lymphovenous bypass, Lymphaticovenular anastomosis

Lymphovenous anastomosis (LVA)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18
• Female
• Unilateral arm lymphedema secondary to breast-cancer treatment
• Active pitting lymphedema
• Presence of dermal backflow in indocyanine green lymphography
• Identifiable lymphatic vessel(s) in the affected arm using an infrared camera and indocyanin green
• Able to provide informed consent
• Able to read, understand and complete Danish questionnaires

You may not qualify if:

• Allergy to iodine
• Pregnant, breast-feeding, or aiming to conceive withing the next year
• History of bilateral breast cancer

Sponsors & Collaborators

• Odense University Hospital: lead
• Vejle Hospital: collaborator
• Zealand University Hospital: collaborator
• Herlev and Gentofte Hospital: collaborator

Study Sites (1)

Department of Plastic Surgery, Odense University Hospital

Odense, Region Syddanmark, 5000, Denmark

Location

MeSH Terms

Conditions

Lymphedema; Breast Cancer Lymphedema; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplastic Processes; Neoplasms

Study Officials

• Caroline Lilja, MD

  Odense University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Multi-center cohort study

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 8, 2024
• Study Start: March 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)