Lymphovenous Bypass Procedure for Secondary Prevention of Lymphedema in Breast Cancer

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

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-18

Study Completion Date

2028-03-21

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Lymphedema Arm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study is a single-blind, pragmatic, parallel arm randomized clinical trial

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Blinding is implemented in two conditions: the principal researcher (Bayu Brahma) will not know the patient's identity or medical history when assessing indocyanine green (ICG) lymphography results, and the patients will not see the type of treatment they received.

Study Groups

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Lymphovenous bypass (LVB)

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.

Group Type EXPERIMENTAL

Lymphovenous bypass (LVB)

Intervention Type PROCEDURE

The Lymphovenous Bypass (LVB) procedure in this study is a microsurgical supermicrosurgery-based intervention specifically designed for the secondary prevention of breast cancer-related lymphedema following axillary lymph node dissection.

Physiotherapy

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Lymphovenous bypass (LVB)

The Lymphovenous Bypass (LVB) procedure in this study is a microsurgical supermicrosurgery-based intervention specifically designed for the secondary prevention of breast cancer-related lymphedema following axillary lymph node dissection.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No