Leak Elimination After Pancreatic Stenting, a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Pancreatic leak
研究概览
简要总结
The purpose of this study is to investigate an intervention to prevent complications after pancreas surgery. The goal is to determine if placing a stent into the pancreatic duct before surgery will decrease or prevent leaking from the pancreatic duct after surgery. Leaks are common after pancreas surgery and can result in serious problems and post-operative pain. The study will compare two groups. One group will have the stent before surgery, and the other group will have standard pancreas surgery, no endoscopy, and 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
- Single (Outcomes Assessor)
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
- •Adult patients (greater than or equal to 18 years of age)
- •Scheduled to undergo an elective laparoscopic or open distal pancreatectomy
- •Willing to undergo pre-operative endoscopy
- •Consenting to the procedure
排除标准
- •Contraindication to abdominal surgery
- •Contraindication to general anesthesia or distal pancreatectomy
- •Contraindication to upper endoscopy or ERCP
- •Prior history of gastric bypass or other abdominal surgery in whom the ampulla will not be accessible via routine ERCP
- •Ongoing pancreatitis
- •Pancreatic necrosis or abscess
- •History of sphincter of Oddi dysfunction
- •History of ERCP-induced pancreatitis
研究组 & 干预措施
1
Pre-operative pancreatic duct stenting
干预措施: Pancreatic duct stenting (Procedure)
2
Control group, no endoscopy and no stent pre-operatively
结局指标
主要结局
Pancreatic leak
时间窗: Post-operative day 3
次要结局
- Peritoneal fluid analysis(Daily)
- Serum biochemical analysis(Daily)
- Clinical outcomes(Daily)
研究者
William R. Brugge, MD
Director of Gastrointestinal Endoscopy
Massachusetts General Hospital