The Effectiveness of Lymphatic Bypass Supermicrosurgery for Primary Lymphedema Prevention After Breast Cancer Axillary Lymph Node Dissection: a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Cumulative incidence of BCRL
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
Blinding is implemented in two conditions: the main researcher (Bayu Brahma) will not know the identity and medical history of the patient when assessing the indocyanine green (ICG) lymphography results and the patients will not know the received type of surgical procedure.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Cumulative incidence of BCRL
时间窗: 1 year
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
次要结局
- BCRL and SCL progression-free survival rate(1 year)
- Quality of life lymphedema(1 year)
- Collateral lymphatic pathway(1 year)
研究者
Bayu Brahma
Principal Investigator
Dharmais National Cancer Center Hospital