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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
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Lymphedema, Breast Cancer

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

First Posted
November 9, 2021
Last Updated
October 31, 2022
Sponsor
University Hospital, Ghent
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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
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LymphoVenous Anastomosis to Prevent Breast Cancer Related Lymphedema

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