Quality Control Study for Multicenter Phase III Trial of Laparoscopic Sentinel Node Biopsy and Stomach Preserving Surgery in Early Gastric Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 16
- 主要终点
- Completement of performance of laparoscopic sentinel lymph node biopsy
研究概览
简要总结
Laparoscopic sentinel lymph node biopsy and stomach preserving surgery in ealry gastric cancer is less invasive method which can increase quality of life. Multicenter phase III trial is requred to validate this method. In this study all items which are necessary for laparoscopic sentinel lymph node biopsy are identified according to checklist and evaluated the performance completement.
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
- •gastric adenocarcinoma in preoperative endoscopic biopsy
- •clinical stage T1-2N0
- •long diameter of tumor <4cm
- •distance between tumor and pylorus or cardia >2cm
- •age: 20-80
- •ECOG: 1 or 0
- •patients will undergo laparoscopic gastrectomy
排除标准
- •definite criteria of endoscopic submucosal dissection (size<2cm, differentiated type, no ulcer)
- •no indication for surgery for cardiovascular, pulmonary disease
- •drug allergy or previous abdominal surgery, radiotherpy
结局指标
主要结局
Completement of performance of laparoscopic sentinel lymph node biopsy
时间窗: within 24 hours after operation
Investigators will make out a checklist after operation for evaluating the completement of performance of laparoscopic sentinel lymph node biopsy. The checklist will be made out within 24 hours.
次要结局
- Detection rate of laparoscopic sentinel lymph node, learning curve(upto 2 years)
研究者
Keun Won Ryu
Principal Investigator
National Cancer Center, Korea