Phase II Study of External Drainage Versus Internal Drainage of Pancreatic Duct With a Stent
试验速览
- 阶段
- 2 期
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- the rate of Postoperative pancreatic fistula within 2 weeks after operation
研究概览
简要总结
Postoperative pancreatic fistula (POPF) and other surgical complications are common after pancreatoduodenectomy (PD) and POPF is a major complication. The drainage of pancreatic duct is important and a stent is usually placed in the operation, but it is still controversial whether the stent drainage is internal or external.
详细描述
The current study is to compare the rate of Postoperative pancreatic fistula(POPF) and other surgical complications after pancreatoduodenectomy (PD).
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age more than 18 years.
- •Received pancreatoduodenectomy.
- •Informed consent has been signed.
排除标准
- •Age less than 18 years
- •Emergency surgery
- •Past history of pancreatic surgery.
结局指标
主要结局
the rate of Postoperative pancreatic fistula within 2 weeks after operation
时间窗: within 2 weeks after operation
Postoperative pancreatic fistula (POPF) is defined as a drain output of any measurable volume of fluid on or after postoperative day 3 with an amylase content greater than 3 times the serum amylase activity.
次要结局
- the rate of postoperative Surgical Complications(2 weeks after operation)