NCT04049734已完成1 期
Evaluation of Oral Losartan in the Prevention of Post-ERCP Pancreatitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 100
- 主要终点
- Number of participants with development of acute pancreatitis
研究概览
简要总结
Oral losartan given in the dose of 50 mg one hour before ERCP was studied in the prevention of post ERCP pancreatitis in 50 patients indicated for ERCP in comparison with another 50 patients underwent ERCP without receiving oral losartan.
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 (Participant)
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 adult patient indicated for ERCP
- •Patients with obstructive jaundice.
- •Patients with dilated intra-hepatic or extra-hepatic bile ducts due to malignant or benign lesions.
排除标准
- •Patients refusing to undergo the procedure or signing the informed consent
- •Patients with clinically evident acute pancreatitis before the procedure
- •Patients with previous endoscopic or surgical sphincterotomy
- •Patients with current use of losartan
- •Patients who are allergic or hypersensitive to losartan or hydro soluble contrast solutions
- •Patients receiving NSAIDS within a week prior to assessment
- •Patients with severe co-morbid conditions as cardiovascular disease, renal failure or decompensated liver cirrhosis.
研究组 & 干预措施
patients received the oral losartan
Active Comparator
50 patients with obstructive jaundice indicated for ERCP and received oral losartan 1 hour before ERCP as a prophylaxis of post-ERCP pancreatitis
干预措施: oral losatan (Drug)
结局指标
主要结局
Number of participants with development of acute pancreatitis
时间窗: 24 hours
Number of participants with development of abdominal pain and elevated serum amylase and/or lipase
次要结局
未报告次要终点
研究者
Shereen Abou Bakr Saleh
Assistant Professor
Ain Shams University
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