Comparison of Vagus Nerve-preserving Robot-assisted Distal Gastrectomy (RADG) and Conventional Robot-assisted Distal Gastrectomy for Advanced Gastric Cancer (AGC)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Recurrence rate
研究概览
简要总结
Through comparative observation of robot vagus nerve preserving distal gastric cancer radical surgery and conventional robot distal gastric cancer radical surgery (not reserved vagus nerve) operative and postoperative indicators, and evaluating the feasibility and safety of vagus nerve preserving distal gastric cancer radical surgery in advanced gastric cancer. Which can provide the evidences for the clinical development of the preserving function gastric cancer surgery.
详细描述
Compare the robot vagus nerve preserving distal gastric cancer radical surgery and conventional robot distal gastric cancer radical surgery (not reserved vagus nerve). Observe the operative and postoperative indicators, and evaluate the feasibility and safety of vagus nerve preserving distal gastric cancer radical surgery in advanced gastric cancer. Which can provide the evidences for the clinical development of the preserving function gastric cancer surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged less than 70 years and more than 18 years;
- •Underwent gastroscopy and biopsy - preoperative definite for advanced gastric cancer invasion depth is T2, T3;
- •The lesion is in the middle and lower stomach;
- •Magix routine upper gastrointestinal barium meal, endoscopic ultrasonography, abdominal CT and chest X ray examination, clearly no nerve invasion and adjacent organ invasion and distant metastasis;
- •The preoperative examination of lung, liver, heart, renal insufficiency, surgical contraindication;
- •The preoperative abdominal CT or abdominal ultrasound without biliary disease and gallbladder stones;
- •No history of gastrointestinal dysfunction and other malignant tumor history;
- •The patients voluntarily participate in the study and signed informed consent.
排除标准
- •Older than 70 years old or because of chemotherapy surgery and complications after intolerance;
- •The vagus nerve invasion or invasion of adjacent organs or confirmed the presence of distant metastasis;
- •Have a history of abdominal surgery or chemotherapy before surgery;
- •The recent cardiovascular hemorrhagic or ischemic disease;
- •The amount of abnormal glucose tolerance or diabetes;
- •Not suitable for robotic surgery, such as body short that mechanical arm can not have enough activity range;
- •The history of biliary calculi or gastrointestinal dysfunction;
- •The other is not suitable for receiving robot surgery;
- •Participated in other clinical studies in the last month;
- •Other researchers not suitable for participation in the study of (HIV infection and intravenous drug addict), or other effects of this clinical study results analysis of the situation.
结局指标
主要结局
Recurrence rate
时间窗: up to 36 months
Recurrence rate in 3 years after operating.
次要结局
- 3-years survival rate(up to 36 months)
- The rate of Calculus of gallbladder(up to 12 months)
- Number of retrieving lymph nodes(up to 1 week)
- Inflammatory factors(6 h, 12 h, 24 h, and 72h after operating)
研究者
Yingxue Hao
Professor
Southwest Hospital, China