Impact on Outcome of Early Endoscopic Extraction of Bile Duct Stones in Biliary Pancreatitis: a Prospective Multicenter Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 900
- 试验地点
- 1
- 主要终点
- Percentage of patients cured or consolidated as a function of time
研究概览
简要总结
Impact on outcome of early endoscopic extraction of bile duct stones in biliary pancreatitis: a prospective multicenter randomized controlled study.
详细描述
Impact on outcome of early endoscopic extraction of bile duct stones in biliary pancreatitis: a prospective multicenter randomized controlled study.
Main objective: to test the interest of early bile duct decompression by endoscopic sphincterotomy after early non invasive diagnosis by endosonography or MR cholangiography.
Prospective multicenter randomized controlled study with direct patient benefit
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Previous medical examination
- •Age over 18
- •Acute biliary pancreatitis
- •Timespan between onset of symptoms and randomization <72h
- •No involvement in another clinical study
- •Informed consent obtained
排除标准
- •Non biliary pancreatitis
- •Age < 18
- •Timespan between onset of symptoms and randomization >72h
- •No follow-up possible beyond 3 months after inclusion
- •Ongoing pregnancy
- •No informed consent
- •No health insurance affiliation
- •Involvement in another clinical study
- •Incapacity to understand subject information
- •Counter indication of MRI examination if echo-endoscopy is not available
研究组 & 干预措施
1
to test the interest of early bile duct decompression by endoscopic sphincterotomy after early non invasive diagnosis by endosonography or MR cholangiography
干预措施: Endoscopic sphincterotomy (Procedure)
结局指标
主要结局
Percentage of patients cured or consolidated as a function of time
时间窗: during 12 months
次要结局
- overall morbidity(during the 36 months)
- overall mortality(during the 36 months)
- endoscopic procedure-related morbidity and mortality(during the 12months)
- LOS(during the 12 months)
- morbidity in the subgroup of patients with bile duct stones left in situ (secondary sphincterotomies)(during the 12 months)
- economic data(during the 36 months)