Cap Assisted Forward-Viewing Endoscope vs Side-Viewing Endoscope for Examination of Major Duodenal Papilla
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- Rate of complete visualisation of papilla duodeni major
研究概览
简要总结
Examination of major duodenal papilla (MDP) using a standard forward-viewing esophagogastroduodenoscopy (S-EGD) is limited. Until now, side-viewing duodenoscope is the modality of choice to examine the MDP. Cap assisted esophagogastroduodenoscopy (CA-EGD) uses a cap fitted to the tip of the scope that can depress the mucosal folds and thus improve visualization and examination of MDP. The aim of this study is to compare CA-EGD to side*viewing duodenoscope for complete examination of MDP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 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
- 是
入选标准
- •indication for elective upper endoscopy
- •age over 18 years
- •ability to provide informed consent
排除标准
- •surgically altered upper gastrointestinal tract
- •known or suspected upper gastrointestinal strictures
- •upper gastrointestinal bleeding
- •biliary stent
- •planned endoscopic intervention
- •American Society of Anesthesiologists class III or higher
- •contraindication for or refusal of sedation with Propofol
- •inability to give informed consent
结局指标
主要结局
Rate of complete visualisation of papilla duodeni major
时间窗: within 5 minutes after intubation of the esophagus
complete visualization is defined by visualization of both proximal and distal ends together with the orifice of the papilla
次要结局
- Duration needed to localize the papilla(within 5 minutes after intubation of the esophagus)
研究者
Mohamed Abdelhafez
Cap Assisted Forward-Viewing Endoscope vs Side-Viewing Endoscope for Examination of Major Duodenal Papilla
Technical University of Munich