LymphoVenous Anastomosis to Prevent Breast Cancer Related Lymphedema (LVARCT)

Lymfo-Veneuse Anastomosen Ter Preventie Van Lymphoedeem

Lymphedema is defined as a chronic condition, caused by lymphostasis. A major part in the Western world consists of iatrogenic lymphedema caused by surgery to the lymph nodes of the axilla or groin. Prophylactic lymphovenous anastomosis (LVA) could be beneficial in the prevention of lymphedema of the extremities.

Study Overview

• Status: Recruiting
• Conditions: Lymphedema, Breast Cancer
• Intervention / Treatment: Procedure: Axilla dissection + Lymphovenous anastomosis

Detailed Description

The investigator is performing a blinded randomized prospective study on 80 patients undergoing an axilla dissection for their breast cancer treatment. One group will receive a LVA at the time of their axilla dissection. Other group will receive standard of care. Follow-up is 2 year.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bernard Depypere, MD; Phone Number: 093325730; Email: bernard.depypere@ugent.be
• Study Contact Backup: Name: Jessie De Kinder; Phone Number: 093321373; Email: jessie.dekinder@uzgent.be

Study Locations

• Belgium
  • Oost-Vlaanderen
    • Gent, Oost-Vlaanderen, Belgium, 9000
      • Recruiting
      • UZ Gent

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• lymph node + breast cancer requiring dissection

Exclusion Criteria:

• previous lymphedema
• BMI >35

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Axilla dissection + Lymphevenous Anastomosis; Surgical bypass between lymphatic vessel and vein	Procedure: Axilla dissection + Lymphovenous anastomosis; surgical bypass between lymphatic vessel and vein
No Intervention: Standard surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The volume via circumferential measurements: swelling < 5%	Comparing the volume of the arm at each study visit via circumferential measurements: swelling < 5%	2 years

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Investigators: Principal Investigator: Bernard Depypere, MD, UZ Gent

Publications and helpful links

General Publications

• Depypere B, Vyncke T, Dhooghe N, Claes K, Blondeel P, Van Landuyt K. A Novel Technique for Preventive Lymphovenous Anastomosis: Anastomosing a Ligated Lymphatic Vessel. Plast Reconstr Surg Glob Open. 2021 Mar 22;9(3):e3509. doi: 10.1097/GOX.0000000000003509. eCollection 2021 Mar.

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2021
• Primary Completion (Estimated): December 27, 2025
• Study Completion (Estimated): December 27, 2026

Study Registration Dates

• First Submitted: November 9, 2021
• First Submitted That Met QC Criteria: October 31, 2022
• First Posted (Actual): November 1, 2022

Study Record Updates

• Last Update Posted (Estimated): November 8, 2024
• Last Update Submitted That Met QC Criteria: November 6, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Lymphatic Diseases; Breast Cancer Lymphedema; Breast Neoplasms; Lymphedema
• Other Study ID Numbers: BC-09374; 2021-004751-16 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No