Laparoscopic Sentinel Node Navigation Surgery for Gastric Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- 3 Year disease free survival
研究概览
简要总结
There are few reports on a dual dye and isotope approach using laparoscopy in gastric cancer sentinel node mapping.
The aim of this study was to evaluate the feasibility of laparoscopic limited gastrectomy with sentinel basin(SB) dissection for gastric cancer using simultaneous indocyanine green (ICG) and 99mTc-antimony sulfur colloid (ASC) injections.
详细描述
Prospective phase II clinical trials for sentinel node navigation surgery(SNNS) in early gastric cancer.
Laparoscopic SNNS:
- ICG and 99mTc-antimony sulfur colloid (ASC) submucosal injection under intraoperative endoscopy
- Sentinel node basin identification and dissection
- Sentinel nodes picking in back table
- Frozen biopsy of sentinel nodes(hematoxylin and eosin staining and immunohistochemistry for cytokeratin)
- If the sentinel node biopsy by frozen section is negative, limited gastrectomy will be performed or if positive, radical D2 gastrectomy will be performed.
Sample size: 100 cases
Study duration: 5 years( 2year enrollment, 3 year follow-up)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 20-80
- •Informed consent
- •No other malignancies
- •cT1N0 stage gastric cancers < 4cm
- •no allergic history of isotope
排除标准
- •Patients eligible for endoscopic submucosal dissection(ESD) with absolute indication
结局指标
主要结局
3 Year disease free survival
时间窗: Postoperative 3 year
Recurrence evaluation by eddoscopy, computed tomography and Positron emission tomography if needed.
次要结局
- Sentinel node detection rate, occurrence of complication ,Qualtity of life and remnant stomach function evaluation.(postoperative 1, 3, 6, 12 month)
研究者
Hyung-Ho Kim
Principal Investigator
Seoul National University Bundang Hospital