Effect of Cap-assisted Esophagogastroduodenoscopy on Observation of Major Duodenal Papilla: a Randomized Non-inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 171
- 试验地点
- 2
- 主要终点
- Rate of complete examination of MDP
研究概览
简要总结
Examination of major duodenal papilla (MDP) using a side-viewing duodenoscope is a golden standard. However, side-viewing duodenoscope is not available in some endoscopic centers. Cap-assisted esophagogastroduodenoscopy (Ca-EGD) using a transparent cap fitted to the tip of the scope has emerged as an alternative method for the observation of MDP. A recent study showed that complete examination of MDP could be achieved in 97% of patients. The investigators hypothesize that Ca-EGD is non-inferior to duodenoscope for the observation of MDP.
详细描述
Interim analyses were planned to be performed by the data and safety monitoring board after data collection has been completed for 50% of the enrollment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years and < 70 years
- •Patients with native MDP who underwent ERCP
排除标准
- •Prior surgery in upper GI tract
- •Prior history of endoscopic sphincterotomy
- •Prior history of MDP treatment
- •Known or suspected obstruction of upper GI tract
- •Patients in poor condition who may not be suitable for Ca-EGD or duodenoscope
- •Pregnancy or lactic women
- •Inability to give informed consent
研究组 & 干预措施
Cap group: Cap-EGD
Undergoing cap-assisted esophagogastroduodenoscopy
干预措施: Cap-EGD (Device)
Duo group: Duo
Undergoing side-viewing duodenoscope
干预措施: Duo (Device)
结局指标
主要结局
Rate of complete examination of MDP
时间窗: 5 minutes after intubation of the esophagus
Complete examination is defined by visualization of both proximal and distal ends with orifice of papilla
次要结局
- Overall endoscopic findings(5 minutes after intubation of the esophagus)
- Endoscopic findings in descending duodenum(5 minutes after intubation of the esophagus)
- MDP examination time(5 minutes after intubation of the esophagus)
- MDP examination score(5 minutes after intubation of the esophagus)
研究者
Yanglin Pan
Associate Professor
Air Force Military Medical University, China