Rectally Administered Indomethacin to Prevent Post-ESWL-pancreatitis (RIPEP)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,370
- 试验地点
- 1
- 主要终点
- the Incidence of Post-ESWL Pancreatitis
研究概览
简要总结
The purpose of the study is to determine whether rectal indomethacin reduces the incidence of post-ESWL pancreatitis.
详细描述
It is a prospective, double-blind, randomized controlled trial. Patients with painful chronic pancreatitis and pancreatic stones (> 5 mm in diameter) who are treated with ESWL at Changhai Hospital will be randomly allocated to indomethacin or placebo therapy before the procedure.
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
- Triple (Participant, Investigator, 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
- •any patient with chronic pancreatitis and pancreatic stones (> 5 mm in diameter) undergoing P-ESWL
- •at least 18 years old
- •provides informed consent
排除标准
- •readmitted to the hospital during the enrollment of the study
- •contraindications to ESWL
- •suspected or established malignancy
- •pancreatic ascites
- •receiving NSAIDs within 7 days
- •contraindication to NSAIDs (including gastrointestinal hemorrhage within 4 weeks or renal dysfunction with serum creatinine >120 μmol/L)
- •presence of coagulopathy or received anticoagulation therapy within 3 days
- •acute pancreatitis within 3 days
- •known active cardiovascular or cerebrovascular disease
- •pregnant or breastfeeding women
- •without a rectum (ie, status post-total proctocolectomy)
研究组 & 干预措施
Indomethacin
Subjects will be randomized to receive a 100-mg indomethacin suppository 30 min before ESWL.
干预措施: indomethacin suppository (Drug)
Glycerin
Subjects will be randomized to receive either a 100-mg identical-appearing placebo (glycerin suppository) 30 min before ESWL.
干预措施: Glycerin Suppository (Drug)
结局指标
主要结局
the Incidence of Post-ESWL Pancreatitis
时间窗: up to 1 months
Patients were identified as post-ESWL pancreatitis if meeting two out of three criteria: pain consistent with acute pancreatitis; amylase or lipase\>3 times normal limit; characteristic findings on imaging, in according to the Revised Atlanta International consensus.
次要结局
- the Incidence and Severity of Asymptomatic Hyperamylasemia and Other Post-ESWL Complications(up to 1 months)
- the Severity of Post-ESWL Pancreatitis Measured as Consensus Definitions for the Major Complications of ERCP（Endoscopic Retrograde Cholangiopancreatography ）(up to 1 months)