Comparative Evaluation of Standard Prophylaxis Versus Divided-dose NSAIDs or Hybrid NSAID and N-acetylcysteine Therapy for the Prevention of Post-ERCP Pancreatitis
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Number of patients who develop post ERCP pancreatitis
研究概览
简要总结
The investigators aimed to perform a comparative study, evaluating the efficacy of three prophylactic approaches aiming to reduce the risk of post-ERCP pancreatitis, using pharmacologic agents with different mechanisms of action (NSAIDs and/or acetylcysteine) in three different regimens.
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
- •age 18 years and older
- •diagnosis of choledocholithiasis
- •indication for ERCP procedures
- •willingness to participate in the study
- •the ability to sign the informed consent
排除标准
- •presence of acute pancreatitis or other inflammatory diseases at admission
- •pregnancy
- •contraindication for NSAID administration
- •recent episode of upper digestive bleeding (less than one month)
- •hypersensibility to antioxidants hypersensibility to antioxidants
- •the necessity of a prophylactic pancreatic stent insertion
- •patients' disapproval to take part in the study
研究组 & 干预措施
Control group
Control group - patients receiving 100 mg indomethacin suppository immediately post ERCP
干预措施: indomethacin suppository (Drug)
Group A
Group A - patients receiving N-acetylcysteine (NAC) 600 mg before performing ERCP and indomethacin suppository 50 mg before and after performing ERCP
干预措施: indomethacin suppository (Drug)
Group A
Group A - patients receiving N-acetylcysteine (NAC) 600 mg before performing ERCP and indomethacin suppository 50 mg before and after performing ERCP
干预措施: N-acetylcysteine (NAC) (Drug)
Group B
Group B - patients receiving indomethacin suppository 50 mg before and 50 mg after ERCP
干预措施: indomethacin suppository (Drug)
结局指标
主要结局
Number of patients who develop post ERCP pancreatitis
时间窗: 24 hours post ERCP
Comparing and evaluating the efficacy of three pharmacological combination therapies (Indomethacin +/- N-acetylcysteine), aiming to prevent acute post ERCP pancreatitis
次要结局
未报告次要终点
研究者
PAVEL LAURA
Principal Investigator, PhD Student
Grigore T. Popa University of Medicine and Pharmacy