Assessment of Pyloric Sphincter Physiology Using EndoFLIP
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Assessment of pyloric sphincter cross-sectional area
研究概览
简要总结
Pylorus is a tubular structure which contains circular muscle, forming pyloric sphincter which separates stomach and duodenum. The motor activity of the pyloric sphincter is less investigated. Antroduodenal manometry is an invasive and time consuming technique also limited by inability to measure compliance of the sphincter.
Recently, a new technique functional lumen imaging probe (FLIP) which is based on principle of impedance planimetry (IP). The endoluminal FLIP (EndoFLIP) EF -100 system uses a multi-detector IP system to produce a 3-dimensional outline of a sphincter. EndoFLIP can measure tissue distensibility and geometric changes through volumetric distention with real-time images. The esophagogastric junction (EGJ) has been well studied using EndoFLIP, studies for assessment of pyloric function are lacking.
详细描述
Objective:
To evaluate the motor activity of pyloric sphincter using Endo FLIP in the form of pressure, diameter, cross-sectional area (CSA) and distensibility in the healthy volunteers.
Methods 20 healthy volunteers will be recruited by local advertising, hospital staff and hospitalised patient's relatives. They will be screened for evidence of organic or functional gastrointestinal disorders, if found to have any will be excluded. Subjects on any medication that is known to affect gastrointestinal function will be excluded.
EndoFLIP method
The subjects will be fasting for at least 8 hours prior to the study. The study will be performed under sedation using monitored anesthesia using propofol in the left lateral decubitus position. Initial endoscopic examination will be performed up to the antrum without traversing the pylorus using (160 Olympus).An EndoFLIP catheter will be passed through biopsy channel into pylorus under direct endoscopic and fluoroscopic visualization.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult >18 years and < 60 years, Both males and females.
- •Healthy volunteers willing to give 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 or 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
Assessment of pyloric sphincter cross-sectional area
时间窗: 1 day
To evaluate the pyloric sphincter cross-sectional area using EndoFLIP in the healthy volunteers.
Assessment of pyloric sphincter diameter
时间窗: 1 day
To evaluate the pyloric sphincter diameter using EndoFLIP in the healthy volunteers.
Assessment of pyloric sphincter distensibility
时间窗: 1 day
To evaluate the pyloric sphincter distensibility using EndoFLIP in the healthy volunteers.
Assessment of pyloric sphincter pressure
时间窗: 1 day
To evaluate the pyloric sphincter pressure using EndoFLIP in the healthy volunteers.
次要结局
未报告次要终点
研究者
Rakesh K
Principal Investigator
Asian Institute of Gastroenterology, India