Prevention of Delayed Post-sphincterotomy Bleeding by High Dose Proton Pump Inhibitor
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 185
- 试验地点
- 1
- 主要终点
- Proportion of patients with bleeding after sphincterotomy
研究概览
简要总结
Endoscopic biliary sphincterotomy is a common and important procedure for biliary access and therapy during endoscopic retrograde cholangiopancreatography (ERCP). Bleeding is one of the important complications related to sphincterotomy. This study determines the role of proton pump inhibitor (PPI) in preventing post-sphincterotomy bleeding in patients undergoing ERCP and sphincterotomy.
详细描述
Eligible patients will be randomized to receive either high dose PPI or standard care. PPI will be given before ERCP and continue for one week after the sphincterotomy.
Both overt and occult bleeding will be documented up to 10 days after the sphincterotomy. Bleeding rates of the two groups will be compared.
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
- •Consecutive patients undergoing ERCP who will require sphincterotomy
排除标准
- •Previous sphincterotomy/papillotomy
- •Previous Polya gastrectomy
- •Patients on maintenance PPI
- •Pregnant and lactating women
- •Age <18 years
- •Previous liver transplant
- •unable to consent for study
研究组 & 干预措施
Esomeprazole
esomeprazole 40mg bd for 10 days
干预措施: Esomeprazole (Drug)
Standard care
No other study drug or placebo will be given
干预措施: Standard care (Other)
结局指标
主要结局
Proportion of patients with bleeding after sphincterotomy
时间窗: 10 days
次要结局
- Proportion of patients who require transfusion, endoscopic hemostasis and other intervention to control bleeding(10 days)
研究者
LEUNG Wai Keung
Clinical Professor
The University of Hong Kong