The Effectiveness of Lymphatic Bypass Supermicrosurgery

N/AActive Not RecruitingNCT05682885

Dharmais National Cancer Center Hospital140 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

140

Conditions

Breast Cancer Related Lymphedema Lymphedema Arm

Interventions

Lymphatic Bypass SupermicrosurgeryPROCEDURE

Axillary Lymph Node Dissection with Lymphatic Bypass Supermicrosurgery

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Dharmais National Cancer Center Hospital

Jakarta, Jakarta Special Capital Region, Indonesia

Outcomes

Primary Outcomes

Cumulative incidence of BCRL

BCRL definition: Post operation subject condition with presence of minimum DB 2 with one or both symptoms (swelling, heaviness), and increment of UEL index \>10% compared to pre operation OR Post operation subject condition with presence of ≥ DB 2 with minimum area 30% in one arm region in one of the arm lymphatic pathway (anterior or posterior), without presence of symptoms (swelling or heaviness), and increment of UEL index \>10% compared to pre operation

Time frame: 1 year

Secondary Outcomes

BCRL and SCL progression-free survival rate

Percentage of subjects who do not progress to subclinical lymphedema or lymphedema during the research.

Time frame: 1 year

Collateral lymphatic pathway

The number of lymphatic pathways flow into the region: supraclavicular, internal mammary, and contralateral axillary and supraclavicular nodes based on the ICG lymphography.

Time frame: 1 year

Quality of life lymphedema

Assessment of lymphedema quality of life score after the surgery using the lymphedema quality of life score questionnaire that is self-reported by the subjects every 2 months and every 3 months in the second year. Calculation of the lymphedema quality of life score is the summation of the score from each question. The minimum score is 0 and the maximum score is 100. A higher score indicates lower lymphedema quality of life.

Time frame: 1 year

Data from ClinicalTrials.gov

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