LymphoVenous Anastomosis to Prevent Breast Cancer Related Lymphedema

Lymphedema, Breast Cancer Clinical Trial

— LVARCT  

Official title:

Lymfo-Veneuse Anastomosen Ter Preventie Van Lymphoedeem

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05601037
• Other study ID #: BC-09374
• Secondary ID: 2021-004751-16
• Status: Recruiting
• Phase: N/A
• Start date: June 30, 2021
• Est. completion date: December 27, 2025

Study information

• Verified date: November 2023
• Source: University Hospital, Ghent
• Contact: Bernard Depypere, MD
• Phone: 093325730
• Email: bernard.depypere[@]ugent.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 27, 2025
• Est. primary completion date: December 27, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• lymph node + breast cancer requiring dissection

Exclusion Criteria:

• previous lymphedema

• BMI >35

Related Conditions & MeSH terms

• Breast Cancer Lymphedema
• Breast Neoplasms
• Lymphedema
• Lymphedema, Breast Cancer

Intervention

Procedure:
• Axilla dissection + Lymphovenous anastomosis
surgical bypass between lymphatic vessel and vein

Locations

Country	Name	City	State
Belgium	UZ GENT	Gent	Oost-Vlaanderen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The volume via circumferential measurements: swelling < 5%	Comparing the volume of the arm at each study visit via circumferential measurements: swelling < 5%	2 years