LymphoVenous Anastomosis to Prevent Breast Cancer Related Lymphedema
LVARCT
Lymfo-Veneuse Anastomosen Ter Preventie Van Lymphoedeem
2 other identifiers
interventional
80
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 30, 2021
CompletedFirst Submitted
Initial submission to the registry
November 9, 2021
CompletedFirst Posted
Study publicly available on registry
November 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 27, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 27, 2026
ExpectedNovember 8, 2024
November 1, 2024
4.5 years
November 9, 2021
November 6, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
The volume via circumferential measurements: swelling < 5%
Comparing the volume of the arm at each study visit via circumferential measurements: swelling \< 5%
2 years
Study Arms (2)
Axilla dissection + Lymphevenous Anastomosis
EXPERIMENTALSurgical bypass between lymphatic vessel and vein
Standard surgery
NO INTERVENTIONStandard surgery
Interventions
surgical bypass between lymphatic vessel and vein
Eligibility Criteria
You may qualify if:
- lymph node + breast cancer requiring dissection
You may not qualify if:
- previous lymphedema
- BMI \>35
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UZ GENT
Ghent, Oost-Vlaanderen, 9000, Belgium
Related 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.
PMID: 33968557BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bernard Depypere, MD
UZ GENT
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 9, 2021
First Posted
November 1, 2022
Study Start
June 30, 2021
Primary Completion
December 27, 2025
Study Completion (Estimated)
December 27, 2026
Last Updated
November 8, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share