Lymphovenous Bypass Procedure for Secondary Prevention of Lymphedema in Breast Cancer

Dharmais National Cancer Center Hospital

Status: Enrolling

Conditions: Lymphedema Arm

Treatments: Procedure: Lymphovenous bypass (LVB)

Study type: Interventional

Funder types: Other

Identifiers

NCT07233863

DP.04.03/11.5/095/2024

Details and patient eligibility

About

This study aims to evaluate the effectiveness of the Lymphovenous Bypass (LVB) procedure compared to physiotherapy alone as secondary prevention of lymphedema in breast cancer patients undergoing axillary lymph node dissection.

Full description

In the intervention group, LVB was performed with intima-to-intima coaptation using the super microsurgery technique. The anastomosis was between the afferent lymphatic vessel and the recipient vein. The upper extremity lymphedema (UEL) index and indocyanine green (ICG) lymphography are utilized to evaluate the progression of lymphedema.

Enrollment: 136 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Breast cancer patients aged ≥ 18 years with an ECOG score > 1
• Breast cancer patients with post-axillary lymph node dissection diagnosed with stage 0 and I lymphedema.
• Those who have never undergone lymphedema physiotherapy.

Exclusion criteria

• Patients with dermal backflow before axillary lymph node dissection (ALND).
• Patients with breast cancer lymphedema who are unable to undergo a 24-month follow-up at Dharmais Cancer Hospital.
• Patients with iodine allergy, severe asthma, decreased kidney function, pregnancy, or breastfeeding.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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136 participants in 2 patient groups

Lymphovenous bypass (LVB)

Experimental group

Description:

Sixty-eight subjects will be needed per group. LVB was performed by creating an intima-to-intima anastomosis between the afferent lymphatic vessels and the recipient veins. After surgery, follow-up will be done every 6 months for 2 years. During follow-up, a comprehensive evaluation will be performed, including history and physical examinations, radiological and histopathological examinations, UEL index, ICG lymphography, and quality-of-life evaluation. Each subject will complete the Lymphedema Quality of Life Questionnaire.

Treatment:

Procedure: Lymphovenous bypass (LVB)

Physiotherapy

No Intervention group

Description:

Sixty-eight subjects will be needed per group. Patients will receive physiotherapy from trained physiotherapists. The protocol includes manual lymphatic drainage (massage techniques), compression, skin care, and arm exercises. Follow-up will be done every 6 months for 2 years. During follow-up, a comprehensive evaluation will be performed, including history and physical examinations, radiological and histopathological examinations, UEL index, ICG lymphography, and quality-of-life evaluation. Each subject will complete the Lymphedema Quality of Life Questionnaire.