Prediction of Post-Endoscopic Retrograde Cholangio-Pancreatography Pancreatitis Based on the Appearance of the Major Duodenal Papilla: a Prospective, Observational, Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,740
- 试验地点
- 1
- 主要终点
- Rate of PEP occurrence
研究概览
简要总结
This observational, prospective study aims at evaluating how the occurrence of post-Endoscopic Retrograde CholangioPancreatography (ERCP) acute pancreatitis (PEP) could be influenced by difficult biliary cannulation that might be previously assessed by the morphological appearance of native major papilla in all the patients undergoing ERCP.
The rate of successful biliary cannulation across papilla types could be used as intraprocedural quality and competence metrics during training. Moreover, recognizing difficult papillae could allow reserving those to experts to decrease the odds of failed cannulation.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with native duodenal papilla;
- •Any indication to ERCP +/- biliary sphincterotomy of duodenal major papilla;
- •Patients able to provide a written informed consent
排除标准
- •ERCP performed for disorders unrelated to biliary tract;
- •Previous upper gastrointestinal tract surgery;
- •Presence of a duodenal stricture (either malignant or benign);
- •Presence of a malignant infiltration of the papilla;
- •Concomitant anticoagulant and/or P2Y12 inhibitors therapy (clopidogrel, prasugrel, ticagrelor) that precludes the treatment;
- •INR > 1.5;
- •Platelets count < 80000/mm3;
- •Unwillingness to sign written informed consent.
结局指标
主要结局
Rate of PEP occurrence
时间窗: within 48 hours after the procedure
Rate of PEP occurrence distributed between the different native major duodenal papilla types
次要结局
- occurrence of intra- and post-procedural complications(within 48 hours after the procedure)
- Rate of difficult biliary cannulation(during the procedure)
- Difference in the rate of difficult biliary cannulation(during the procedure)
- Rate of intraoperative complications(during the procedure)
- Rate of postoperative complications except for PEP(within 48 hours after the procedure)