NCT02877797已完成不适用
The Use of Cap Assisted Forward Viewing Esophagogastroduodenoscopy to Examine the Major Duodenal Papilla
Technical University of Munich2 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2016年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 101
- 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
Aim of the present study is the evaluation of the diagnostic value of a cap assisted upper GI-endoscopy compared to a standard upper GI-endoscopy regarding the visualisation and evaluation of the papilla duodeni major.
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
- 否
入选标准
- •Indication of Esophagogastroduodenoscopy independent from the study
- •Written informed
- •Age ≥ 18 years
排除标准
- •Absence of written informed consent
- •Contraindication or absence of informed consent regarding sedation with Propofol
- •Postoperativ changes of the upper GI-tract
- •Intention of endoscopic intervention
- •Suspicion of upper GI-bleeding
- •Suspicion of stenosis of the esophagus
- •Stent in the papilla duodeni major
- •ASA (American Society of Anesthesiologists) classification ≥ 3
结局指标
主要结局
Rate of complete visualisation of papilla duodeni major
时间窗: 120 seconds
visualisation: none, incomplete, complete
次要结局
- complication rate(up to one week)
- time of investigation(up to 10 minutes)
- Diagnostic yield in the upper GI-tract(up to 10 minutes)
研究者
Monther Bajbouj
Prof. Dr. med.
Technical University of Munich
研究点 (2)
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