Study of Esophageal and Gastric Diseases With Robotically Controlled Magnetic Capsule Endoscopy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Reflux esophagitis
研究概览
简要总结
Magnetically controlled capsule endoscopy (MCCE) is an outstanding opportunity for the painless endoscopic screening of the esophagus and stomach before small bowel examiantion. Further improvement in patients positioning might increase the esophageal transit time of the capsule endoscope and could improve the sensitivity and specificity of the esophageal MCCE investigation. Our present study aimed to compare the visualization of the esophagus (especially the Z-line) with different capsule swallowing protocols.
详细描述
Magnetic controlled capsule endoscope (MCCE) systems have been developed over the last 10-15 years to examine the upper GI tract, particularly the stomach. The new Navicam MACE system consists of a magnetic capsule endoscope, an external control magnet, a data recording kit and a computer workstation. With the appropriate software, allows real-time tracking and monitoring of the capsule inside the body. This method may in the near future be an optimal non-invasive method for screening gastric cancer and Barrett's oesophagus in high-risk populations.
Esophagogastroduodenoscopy (EGD) is the gold standard diagnostic test, however it is very inconvenient for patients without sedation.
The aim of our present study was a feasibility study to evaluate the safety and efficacy of Ankon MCCE for the investigation of esophageal abnormalities in patients referred for small bowel capsule endoscopy in our endoscopy department, to develop and test a method to use MCCE for esophageal examination, and to analyze the visualization of esophageal mucosa with our newly developed capsule swallowing protocol and manual capsule maneuvering.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •- patients referred for small bowel capsule endoscopy in any indication
排除标准
- •known or suspected stricture in the GI tract
- •previous surgery with bowel anastomosis
- •swallowing complaints
- •implanted cardioverter defibrillator
- •inability to sign the informed consent
结局指标
主要结局
Reflux esophagitis
时间窗: 1 year
Proportion and the severity of reflux (Los Angeles classification) comparing to gastroscopy
Diseases
时间窗: 1 year
Proportion of other disorders of oesophagus and stomach comparing to gastroscopy
Stomach examination
时间窗: 1 year
Analyze the visualisation of gastric mucosa with MACE system
次要结局
- Restrain time(1 year)
- Cleanliness(1 year)
研究者
László Madácsy Md, PhD
Clinical Professor
Bács-Kiskun County Teaching Hospital