NCT02905669Unknown不适用
Measurement of Contractile Activity and Distensibility of the Esophago-gastric Junction, of the Esophagus and of the Pylorus: Normal Values in Controls Under General Anesthesia (NormaFLIP Study)
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Esophago-gastric junction distensibility
研究概览
简要总结
Impedance planimetry using Endoscopic Functional Lumen Imaging Probe (EndoFLIP) device is a promising diagnostic tool to assess esophageal, esophago-gastric junction and pylorus function. It allows the measurement of esophageal and pylorus distensibility as well as contractile activity in response to distension. Examination is useful performed under sedation. General anesthesia might affect distensibility values. The aim of this study is to normal values for esophageal, esophago-gastric junction and pylorus distensibility in controls during an upper gastro-intestinal endoscopy performed under general anesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Subject older than 18 years and younger than 80 years
- •Subject referred for upper gastro-intestinal endoscopy under general anesthesia for anemia, intestinal metaplasia in the stomach, Helicobacter pylori screening, or submucosal dissection
- •Subject with health insurance
- •Written informed consent
排除标准
- •Patient younger than 18 years or older than 80 years
- •Pregnancy or breast feeding
- •Previous history of esophago-gastric surgery or vagotomy
- •Previous history of Parkinson disease or diabetes mellitus
- •Contra-indication to upper gastro-intestinal endoscopy
- •Esophageal varices
- •Esophageal diameter smaller than 5 mm
- •Contra-indication to general anesthesia
- •Hiatal hernia greater than 3 cm on endoscopy
- •Esophageal or gastric cancer otherwise than superficial lesion with indication of submucosal dissection
- •Typical symptoms (heartburn, regurgitation) of gastro-esophageal reflux disease and/or gastroesophageal reflux disease (GERD)-Q score greater or equal to 8
- •Nausea, vomiting or epigastric pain
- •Dysphagia with Sydney score greater ou equal to 50
- •Incapability to give consent
- •No written informed consent
- •Participation to another study at the same time
结局指标
主要结局
Esophago-gastric junction distensibility
时间窗: The day of gastro-intestinal endoscopy
次要结局
- Side effects occurence(The day after gastro-intestinal endoscopy)
- Esophageal distensibility(The day of gastro-intestinal endoscopy)
- Pylorus distensibility(The day of gastro-intestinal endoscopy)
- Esophageal contractile activity in response to distension(The day of gastro-intestinal endoscopy)
研究者
研究点 (2)
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