If Chronic Gallbladder Diseases Increase the Occurence of Post Endoscopic Retrograde Choledochopancreatography Choledocholithiasis（a Prospective Multi-center Cohort Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,019
- 试验地点
- 3
- 主要终点
- Number of Acute PEC(post-ERCP-cholecystitis )
研究概览
简要总结
This is a prospective, multi-centre trial conducts at 4 ERCP centers in China designed to determine if chronic gallbladder diseases increase the incidence of Post-Endoscopic Retrograde Choledochopancreatography-Choledocholithiasis (PEC)
详细描述
Endoscopic Retrograde Choledochopancreatography(ERCP) has the advantages of less injury and faster recovery for common bile duct stone patients. However, according to our retrospective study, ERCP will has a mostly 10% possibility to get an acute purulent cholecystitis which often requires emergency intervention, when patients combined with chronic gallbladder diseases, such as chronic cholecystitis, asymptomatic gallstones, and gallbladder wall thickness, the incidence of PEC will increase accordingly. The aim of this study is to observe if chronic gallbladder disease will increase the occurence of PEC and develop a high-risk PEC model.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ERCP patients with gallbladder in situ
排除标准
- •Acute cholecystitis before surgery
- •Gallbladder has been removed
- •Gastrointestinal reconstruction
- •Unwillingness or inability to consent for the study
- •Unstable vital signs Coagulation dysfunction (INR>1.5)
- •Low peripheral blood platelet count (<50×10 ^9 / L) or using anti-coagulation drugs
- •Preoperative coexistent diseases: acute pancreatitis, GI tract hemorrhage, severe liver disease (such as decompensated liver cirrhosis, liver failure and so on), septic shock Biliary- duodenal fistula confirmed during ERCP
- •Pregnant women or breastfeeding
结局指标
主要结局
Number of Acute PEC(post-ERCP-cholecystitis )
时间窗: 1month
When the PEC occurs, with right upper abdominal pain, White Blood Cell increasing, gallbladder wall ≥4mm or crudely, temperature might be more than 38 degree centigrade
次要结局
- Number of Cholangitis(1 month)
- Number of Pancreatitis(1month)
- Number of Perforation(1 month)
研究者
Wenbo Meng
M.D., Ph. D, Direct of surgery
Hepatopancreatobiliary Surgery Institute of Gansu Province