LymphoVenous Anastomosis to Prevent Breast Cancer Related Lymphedema (LVARCT)
Primary Purpose
Lymphedema, Breast Cancer
Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Axilla dissection + Lymphovenous anastomosis
Sponsored by
About this trial
This is an interventional prevention trial for Lymphedema, Breast Cancer
Eligibility Criteria
Inclusion Criteria: lymph node + breast cancer requiring dissection Exclusion Criteria: previous lymphedema BMI >35
Sites / Locations
- UZ GENTRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Axilla dissection + Lymphevenous Anastomosis
Standard surgery
Arm Description
Surgical bypass between lymphatic vessel and vein
Standard surgery
Outcomes
Primary Outcome Measures
The volume via circumferential measurements: swelling < 5%
Comparing the volume of the arm at each study visit via circumferential measurements: swelling < 5%
Secondary Outcome Measures
Full Information
NCT ID
NCT05601037
First Posted
November 9, 2021
Last Updated
October 31, 2022
Sponsor
University Hospital, Ghent
1. Study Identification
Unique Protocol Identification Number
NCT05601037
Brief Title
LymphoVenous Anastomosis to Prevent Breast Cancer Related Lymphedema
Acronym
LVARCT
Official Title
Lymfo-Veneuse Anastomosen Ter Preventie Van Lymphoedeem
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 30, 2021 (Actual)
Primary Completion Date
December 27, 2024 (Anticipated)
Study Completion Date
December 27, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphedema, Breast Cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
blinded randomized prospective
Masking
Participant
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Axilla dissection + Lymphevenous Anastomosis
Arm Type
Experimental
Arm Description
Surgical bypass between lymphatic vessel and vein
Arm Title
Standard surgery
Arm Type
No Intervention
Arm Description
Standard surgery
Intervention Type
Procedure
Intervention Name(s)
Axilla dissection + Lymphovenous anastomosis
Intervention Description
surgical bypass between lymphatic vessel and vein
Primary Outcome Measure Information:
Title
The volume via circumferential measurements: swelling < 5%
Description
Comparing the volume of the arm at each study visit via circumferential measurements: swelling < 5%
Time Frame
2 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
lymph node + breast cancer requiring dissection
Exclusion Criteria:
previous lymphedema
BMI >35
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bernard Depypere, MD
Phone
093325730
Email
bernard.depypere@ugent.be
First Name & Middle Initial & Last Name or Official Title & Degree
Jessie De Kinder
Phone
093321373
Email
jessie.dekinder@uzgent.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernard Depypere, MD
Organizational Affiliation
UZ GENT
Official's Role
Principal Investigator
Facility Information:
Facility Name
UZ GENT
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33968557
Citation
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.
Results Reference
background
Learn more about this trial
LymphoVenous Anastomosis to Prevent Breast Cancer Related Lymphedema
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