Clinical Study on Regularity of Lymphatic Drainage and Surgical Treatment of Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Disease free survival
研究概览
简要总结
The investigatorsconduct the precise sentinel lymph node biopsy using preoperative computed tomographic lymphography in breast cancer. The investigators aimed to summarize the law of lymphatic drainage of breast, and to conduct the accurate surgical treatment of breast cancer.
详细描述
AIM:Sentinel lymph node biopsy (SLNB) is the standard technique for patients with early stage breast cancer. The investigators conduct the precise sentinel lymph node biopsy using preoperative computed tomographic lymphography in breast cancer. And The investigators identify the true sentinel lymph nodes(SLNs) followed by lymphatic ducts during operation. The investigators aimed to identify the non-sentinel lymph node, and to investigate the relationship between upper extremity lymphatic drainage. The SLNB procedure could avoid unnecessary lymph node resection and reduce treatment-related sequela.
Arm1：
- Participants received preoperative computed tomographic lymphography
- Participants received sentinel lymph node biopsy（SLNB）
- Participants received stained non-sentinel lymph node resection during SLNB
- Participants received axillary reverse mapping dissection Arm2： Participants receive sentinel lymph node biopsy
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)
- •participants 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
- •participants has received neo-adjuvant system therapy
研究组 & 干预措施
SLNB and non-slns resection
- Participants only receive SLNB
- preoperative CT lymphography
- SLNB with stained non-SLN resection
- SLNB with ARM dissection
干预措施: Participants receive SLNB as well as non SLNs resection (Procedure)
SLNB group
Participants only receive SLNB
干预措施: Participants receive SLNB as well as non SLNs resection (Procedure)
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
Professor
Shandong University