LymphoVenous Anastomosis to Prevent Breast Cancer Related Lymphedema
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Axilla dissection + Lymphovenous anastomosis.
- Who it may be relevant to
- Registry conditions: Lymphedema, Breast Cancer. Basic parameters: 18 years — 99 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Lymfo-Veneuse Anastomosen Ter Preventie Van Lymphoedeem
Overview
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.
Interventions
- Procedure Axilla dissection + Lymphovenous anastomosis
surgical bypass between lymphatic vessel and vein
Primary outcome measures
- The volume via circumferential measurements: swelling < 5% [Time frame: 2 years]
Eligibility criteria
Inclusion criteria
- lymph node + breast cancer requiring dissection
Exclusion criteria
- previous lymphedema
- BMI >35
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Belgium · 1 center
- UZ GENT — Ghent
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. PMID 33968557
Identifiers
NCT: NCT05601037 · BC-09374 · 2021-004751-16