The Effectiveness of Lymphatic Bypass Supermicrosurgery (ELYBS)

Dharmais National Cancer Center Hospital

Status: Active, not recruiting

Conditions: Lymphedema Arm; Breast Cancer Related Lymphedema

Treatments: Procedure: Lymphatic Bypass Supermicrosurgery

Study type: Interventional

Funder types: Other

Identifiers

NCT05682885

227/KEPK/IX/2022

Details and patient eligibility

About

This study evaluate the effectiveness of lymphatic bypass supermicrosurgery (LBS) and axillary lymph node dissection (ALND) compare to ALND alone to prevent breast cancer treatment-related lymphedema (BCRL).

Full description

In the intervention group, LBS was performed after ALND with the intima-to-intima coaptation using the supermicrosurgery technique. The anastomosis is done between the afferent lymphatic vessel to the recipient's vein, or if possible, from the afferent to the efferent lymphatic vessel. The upper extremity lymphedema (UEL) index and indocyanine green (ICG) lymphography are utilized to evaluate the development of lymphedema.

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Breast cancer patient aged >18 years old
• Breast cancer patient with clinically ALNs metastases (cN1 or cN2).
• Breast cancer patient with no clinical metastasis and tumor size ≥5cm or no sentinel lymph node biopsy facility in the hospital.
• Any breast cancer patients that receive neoadjuvant systemic therapy.

Exclusion criteria

• Stage IV breast cancer patients who do not show clinical and radiological improvement after primary systemic therapy.
• Breast cancer patients with previous surgeries such as mastectomy, axillary lymph node biopsy, sentinel lymph node biopsy (SLNB), and ALND.
• Breast cancer patients with prior breast, chest wall, axillary, or neck radiotherapy.
• Breast cancer patients with preoperative lymphatic system abnormality detected by ICG lymphography.
• Breast cancer patients with iodine allergy, asthma, decreased kidney function, pregnancy, and lactation.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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140 participants in 2 patient groups

Axillary lymph node dissection with LBS

Experimental group

Description:

70 subjects will be needed for each group. A standard mastectomy or lumpectomy incision is made and ALND will be done in the same incision. The lymphatic vessels and lymph nodes will be resected using a near-infrared (NIR) camera. To locate lymphatic vessels, a microscope with ICG lymphography navigation is employed. LBS was performed by making intima-to-intima anastomosis between the afferent lymphatic vessels and the recipient's veins, or to the efferent lymphatic vessels. The anastomosis patency will be assessed by observing the ICG fluorescent flow. After surgery, follow-up will be done every 2 months and every 3 months in the second year. UEL index, ICG lymphography, and quality of life evaluation will be done. The cumulative incidence of BCRL, the free survival time of BCRL, and subclinical lymphedema (SCL) progression will be reported descriptively. BCRL risk factors and collateral lymphatic pathway will be observed as well.

Treatment:

Procedure: Lymphatic Bypass Supermicrosurgery

Axillary lymph node dissection without LBS

No Intervention group

Description:

70 subjects will be needed for each group. A standard mastectomy or lumpectomy incision is made and ALND will be done in the same incision. After primary breast cancer removal, a standard ALND level I, II, and if necessary, level III is performed. After surgery, follow-up will be done every 2 months and every 3 months in the second year. History taking, physical examination, radiology and histopathology examination, UEL index, and ICG lymphography evaluation will be done during follow-up. Each subject will complete the lymphedema quality of life questionnaire. The cumulative incidence of BCRL, the free survival time of BCRL, and SCL progression will be reported descriptively. BCRL risk factors and collateral lymphatic pathway will be observed as well.