Randomized Study Assessing the Effect of Transpapillary Pancreas Duct Stent in Resection of the Pancreatic Tail
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Drain fluid content analyses
研究概览
简要总结
Randomized study assessing the effect of transpapillary pancreas duct stent in resection of the pancreatic tail.
详细描述
Resection of the pancreatic tail is fraught with fistula or leakage of pancreatic enzymes to varying degrees between 13-64%, depending upon which definition one uses. The "downstream" control of the pancreatic duct with the help of a transpapillary stent might minimize the risk for leakage over the transected pancreas surface.
Trial evaluation will be A. The pancreatic bed was drained and postoperatively the fluid was continuously collected and daily analysed for pancreatic amylase and bilirubin. Daily measurement of pancreatic enzyme content in the drain fluid, at least for 5 post operative days or as long as the patient retains the drain. X-Amylase and X-Protein as long as the patient has the external drain.
B. Co-variables measured in the form of: operation time, complications in relation to diagnosis, duration of hospitalization. Patients receiving a pancreas stent are followed in order to evaluate the natural course of the pancreas stent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria include all patients planned to undergo resection of the pancreatic body-tail are invited to participate.
排除标准
- •The Patients who, at the time of exploration, judged to have a tumour, which is un-resectable.
结局指标
主要结局
Drain fluid content analyses
时间窗: At least 5 postoperative days
Post-operative daily measurement of X-Amylase,as long as the patient has the external drain and for at least 5 postopertaive days.
次要结局
- Co-variables measured in the form of: operation time, complications in relation to diagnosis, duration of hospitalization and cost. Patients receiving a pancreas stent are followed in order to evaluate the natural course of the pancreas stent(At least 5 postoperative days)