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Recruiting

NCT Number: NCT05601037

LymphoVenous Anastomosis to Prevent Breast Cancer Related Lymphedema

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.

Recruiting

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Key information

Conditions

Lymphedema, Breast Cancer Breast Cancer Lymphedema Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year–99 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UZ GENT

Ghent, Oost-Vlaanderen, 9000, Belgium

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • lymph node + breast cancer requiring dissection

Exclusion criteria

  • previous lymphedema
  • BMI >35

Treatment and study plan

Axilla dissection + Lymphovenous anastomosis

Procedure

surgical bypass between lymphatic vessel and vein

Primary outcomes

  1. The volume via circumferential measurements: swelling < 5%

    Time frame: 2 years

    Comparing the volume of the arm at each study visit via circumferential measurements: swelling < 5%

Study contacts

Contact information is provided by the study sponsor or research team.

Bernard Depypere, MD

CONTACT

[email protected]

093325730

Jessie De Kinder

CONTACT

[email protected]

093321373

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Official study title

Lymfo-Veneuse Anastomosen Ter Preventie Van Lymphoedeem

Acronym: LVARCT

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Nov 1, 2022
Registry last updated
Nov 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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