Sentinel Lymph Node Biopsy With or Without Para-Sentinel Lymph Node Dissection in Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Disease free survival
研究概览
简要总结
Sentinel lymph node biopsy（SLNB） is an established way of predicting axillary nodal metastasis in early breast cancer. We aim to determinethe，in a prospective randomized, controlled trial, effect of sentinel lymph node biopsy with para-sentinel lymph node(SLN) dissection versus sentinel lymph node biopsy without para-sentinel lymph node dissection on outcomes after breast surgery.
详细描述
Aim: Compare the disease-free survival (DFS) and overall survival (OS) of breast cancer patients who are randomized to receive sentinel lymph node biopsy with para-sentinel lymph node dissection group vs. those receive only sentinel lymph node biopsy without para-sentinel lymph node dissection
Outline:
Patients are randomized assigned to the following one of two groups and are followed annually.
Arm I: Patients receive sentinel lymph node biopsy with para-sentinel lymph node dissection Arm II: Patients receive only sentinel lymph node biopsy without para-sentinel lymph node dissection
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •histologically confirmed primary breast cancer by core needle biopsy or excisional biopsy
- •abnormal para-sentinel lymph node was found by ultrasound examination
- •ultrasound-guided fine needle aspiration cytology of these nodes were performed
- •the result of fine needle aspiration cytology was negative (no tumour cell was found)
- •patient planed to perform SLNB
排除标准
- •pathological diagnosed ductal carcinoma in situ by excisional biopsy
- •the result of fine needle aspiration cytology was positive
- •patient has received neo-adjuvant system therapy
结局指标
主要结局
Disease free survival
时间窗: Up to 10 years
Time from randomization to recurrence, metastasis, appearance of a second primary tumor, or death from any cause, whichever occurs first, assessed up to 10 years.
次要结局
- Overall survival(Up to 10 years)
研究者
Qifeng Yang
Chairman of Department of Breast Surgery, Qilu Hospital
Shandong University