Minimal Invasive Versus Open Radical Antegrade Modular Pancreatosplenectomy for Left-sided Pancreatic Cancer: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 125
- 试验地点
- 2
- 主要终点
- Posteroperative length of stay
研究概览
简要总结
Pancreatic cancer is regarded as "the king of cancer". It is extremely malignant, with a low sensibility to chemotherapy and radiotherapy, and a poor prognosis. Surgical treatment is very important for pancreatic cancer. Radical antegrade modular pancreatosplenectomy (RAMPS) is a standard method for treating pancreatic cancer at the body and tail of pancreas. In the same surgical approach, the investigators are going to compare and discuss the advantages of laparoscopic and open RAMPS in the RCT study.
详细描述
Open RAMPS is widely used now to treat pancreatic cancer at the body and tail of pancreas. Meanwhile, laparoscopic surgery is proved to have many advantages in other operations. According to primary retrospective study of open and laparoscopic RAMPS, there was no statistically significant difference in the long-term follow-up situations between these two groups, indicating the safety of both this two surgical approaches. The investigators would like to promote a prospective RCT study, to give more evidences of the superiority of laparoscopic RAMPS.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years old and older;
- •Pathology diagnosed as pancreatic adenocarcinoma or suspect cancer mass at the pancreatic body or tail;
- •Patients who are eligible and planned to be performed RAMPS procedure;
- •Resectable or borderline resectable tumor by preoperative evaluation.
排除标准
- •Patients with evidence of distant metastasis or advanced arterial invasion so that are not able to continue radical surgery;
- •Patients who are not willing to be performed open and/or mi-RAMPS;
- •Not pancreatic adenocarcinoma by posteroperative pathology.
结局指标
主要结局
Posteroperative length of stay
时间窗: Until patients were discharged
The days between the postoperative day-1 to the date when patient was eligible to be discharged.
次要结局
- Estimated blood loss(During the surgery)
- Overall Survival(more than 1 year)
- Disease Free Survival(more than 1 year)
- Postoperative pain(Until patients were discharged)
- III-IV grade postoperative complication rate(No less than 3 months.)
- R0 resection(up to approximately 2 weeks)
- Operative time(during the surgery)
研究者
Dai Menghua
Professor
Peking Union Medical College Hospital