NCT03822676Unknown不适用
Prophylactic Pancreatic Stent for the Prevention of Post Operative Pancreatic Fistula Before Segmental Pancreatectomy
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Postoperative pancreatic fistula
研究概览
简要总结
Postoperative pancreatic fistula (POPF) remains one of the most harmful complications after pancreatic resection. Some studies have indicated that endoscopic pancreatic stenting was effective in the treatment of POPF. However, the results of prospective RCTs for the prophylactic effect of pancreatic stent insertion against POPF were controversial. This single center prospective randomized trial was designed to compare the outcome after segmental pancreatectomy with prophylactic drainage stent versus no stent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •All patients scheduled for elective segmental pancreatectomy
排除标准
- •Subjects for whom ERCP procedures are contraindicated
- •If female, pregnant based on a positive hCG serum or an in vitro diagnostic test result or breast-feeding
- •Age less than 18 year
- •Emergency surgery
- •Previous pancreatic surgery
研究组 & 干预措施
Stent
Experimental
Prophylactic pancreatic stent before segmental pancreatic surgery
干预措施: Prophylactic pancreatic stent (Device)
No stent
No Intervention
No prophylactic stent before surgery
结局指标
主要结局
Postoperative pancreatic fistula
时间窗: from postoperative day 3 to 30
Grade B and C
次要结局
- Severity of pancreatic fistula(from postoperative day 3 to 30)
- Length of stay(from postoperative day 1 to discharge)
研究者
研究点 (1)
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