LymphoVenous Anastomosis to Prevent Breast Cancer Related Lymphedema

NCT ID: NCT05601037

Last Updated: 2024-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-30

Study Completion Date

2026-12-27

Brief Summary

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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

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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.

Conditions

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Lymphedema, Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

blinded randomized prospective
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Axilla dissection + Lymphevenous Anastomosis

Surgical bypass between lymphatic vessel and vein

Group Type EXPERIMENTAL

Axilla dissection + Lymphovenous anastomosis

Intervention Type PROCEDURE

surgical bypass between lymphatic vessel and vein

Standard surgery

Standard surgery

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Axilla dissection + Lymphovenous anastomosis

surgical bypass between lymphatic vessel and vein

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* lymph node + breast cancer requiring dissection

Exclusion Criteria

* previous lymphedema
* BMI \>35
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bernard Depypere, MD

Role: PRINCIPAL_INVESTIGATOR

UZ GENT

Locations

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UZ GENT

Ghent, Oost-Vlaanderen, Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Bernard Depypere, MD

Role: CONTACT

093325730

Jessie De Kinder

Role: CONTACT

093321373

References

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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.

Reference Type BACKGROUND
PMID: 33968557 (View on PubMed)

Other Identifiers

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2021-004751-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

BC-09374

Identifier Type: -

Identifier Source: org_study_id

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