NCT01774604终止3 期
Rectal Indomethacin to Prevent Post-ERCP Pancreatitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 449
- 试验地点
- 1
- 主要终点
- Number of Patients Who Developed Acute Pancreatitis
研究概览
简要总结
The purpose of this study is to assess whether peri-procedural administration of rectal indomethacin, compared to placebo, can reduce the incidence of post-ERCP pancreatitis.
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
- Quadruple (Participant, Care Provider, 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
- •Scheduled for an ERCP at Dartmouth-Hitchcock
- •Age greater than 18 years old
- •Ability to provide written informed consent
排除标准
- •Inability to provide written informed consent
- •ERCP being performed for diagnosis and/or treatment of acute pancreatitis
- •Current ongoing acute pancreatitis
- •Previously documented allergy to Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
- •Contra-indication to NSAID therapy (creatinine level >1.4 or active peptic ulcer disease), already taking NSAIDs (other than aspirin therapy for cardioprotection)
- •Pregnant or nursing mothers
研究组 & 干预措施
Indomethacin
Experimental
Indomethacin 100 mg Per Rectum (PR) x 1 in peri-procedural period
干预措施: Indomethacin (Drug)
Placebo
Placebo Comparator
Placebo suppositories (#2)
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Patients Who Developed Acute Pancreatitis
时间窗: From randomization to 30 days after ERCP
Number of patients who developed pancreatitis following ERCP based on Atlanta Classification
次要结局
- Number of Patients Who Developed Moderately Severe Pancreatitis(From randomization to 30 days after ERCP)
- Number of Patients Who Developed Severe Pancreatitis(From randomization to 30 days after ERCP)
- Number of Patients With 30 Days Hospital Re-admission(From randomization until 30 days after ERCP)
- Number of Patients Who Developed Mild Pancreatitis(From randomization to 30 days after ERCP)
- Number of Patients Who Developed Gastrointestinal Bleeding(From randomization to 30 days after ERCP)
- Number of Patient Deaths(From randomization to 30 days after ERCP)
研究者
研究点 (1)
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