LymphoVenous Anastomosis to Prevent Breast Cancer Related Lymphedema (LVARCT)

Ghent University Hospital (UZ)

Status: Enrolling

Conditions: Lymphedema, Breast Cancer

Treatments: Procedure: Axilla dissection + Lymphovenous anastomosis

Study type: Interventional

Funder types: Other

Identifiers

NCT05601037

BC-09374

2021-004751-16 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: Female

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• lymph node + breast cancer requiring dissection

Exclusion criteria

• previous lymphedema
• BMI >35

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

80 participants in 2 patient groups

Axilla dissection + Lymphevenous Anastomosis

Experimental group

Description:

Surgical bypass between lymphatic vessel and vein

Treatment:

Procedure: Axilla dissection + Lymphovenous anastomosis

Standard surgery

No Intervention group

Description:

Standard surgery