Effect of Anatomy of Major Duodenal Papilla on the Difficulty of Cannulation During Endoscopic Retrograde Cholangiopancreatography (ERCP)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 658
- 试验地点
- 4
- 主要终点
- post-ERCP pancreatitis incidence
研究概览
简要总结
Selective cannulation is an essential step for the success of ERCP. The successful cannulation is influenced by types of disease (such as Sphincter of Oddi Dysfunction and duodenal stricture), the experience of endoscopists and the anatomy of papilla. It is suggested that the size, morphology, orientation and location of major duodenal papilla (MDP), could cause a difficult cannulation (Endoscopy 2016; 48: 657-683). However, the related evidences are limited. The investigators hypothesized that special anatomy of papilla, such as a lanky shape (defined by the higher ratio of length to width) and a deeper location, could increase the difficulty of cannulation. Here the investigators investigated the effects of the anatomy of major duodenal papilla on post-ERCP pancreatitis and the procedure of cannulation in patients undergoing ERCP.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18-80
- •Patients with native papilla who underwent ERCP
排除标准
- •Prior endoscopic sphincterotomy
- •Minor pancreatic duct as the targeted duct
- •History of prior upper gastrointestinal surgery, such as Billroth I, II and Roux-en-Y
- •Fistula of MDP
- •Papillary carcinoma or adenoma
- •Duodenal obstruction, type II
- •Prior stent placement in common bile duct or pancreatic duct
- •Pregnant or breastfeeding women
- •Unwilling or inability to provide consent
结局指标
主要结局
post-ERCP pancreatitis incidence
时间窗: 48 hours
frequency of post-ERCP pancreatitis
次要结局
- Rate of difficult cannulation(3 hours)
- Cannulation attempts(3 hours)
- Total cannulation time(3 hours)
- Unintended pancreatic duct cannulation(3 hours)
- Complication rate(48 hours)
研究者
Yanglin Pan
Associate Professor
Air Force Military Medical University, China