Magnetic-controlled Capsule Endoscopy vs. Gastroscopy for Detection of Gastric Diseases: A Prospective Self-controlled Comparative Multicenter Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Number of subjects diagnosed with gastric diffuse lesions by MCE Versus Standard Gastroscopy
研究概览
简要总结
A new Magnetic-controlled Capsule Endoscopy (MCE) was developed by ANKON and got SFDA's approval in China in 2013. It has recently been evaluated to compare the diagnostic accuracy of MCE with that of standard gastroscopy for gastric diseases in 70 patients with encouraging results (In Press). To further testify the diagnostic accuracy of MCE for both the diffuse and focal diseases in stomach, we performed this single-blinded multi-center prospective study compared MCE with gastroscopy in patients with gastric symptoms and indication for upper GI Endoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Single (Investigator)
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
- •Patients presented with gastric symptoms and ready for the first Upper GI endoscopy
- •Patients with known focal gastric diseases: gastric ulcer, gastric polyps, early gastric cancer, gastric stromal tumors and so on.
- •Age of 18 years to 70 years
排除标准
- •Patients with impaired bowel movement from ileus or organic digestive diseases
- •Patients with known large and obstructing tumors of the upper GI tract
- •Patients after upper GI surgery or abdominal surgery altering GI anatomy
- •Patients under full anticoagulation
- •Patient in poor general condition
- •Patients using equipment that may be affected by radio transmission
- •Patients using equipment that may be affected by magnetic field
- •Pregnancy or suspected pregnancy
结局指标
主要结局
Number of subjects diagnosed with gastric diffuse lesions by MCE Versus Standard Gastroscopy
时间窗: 2 days
Number of gastric focal lesions founded by MCE Versus Standard Gastroscopy
时间窗: 2 days
次要结局
- Volume of water and drugs used for gastric preparation(1 hour)
- Scores of the cleanliness of stomach after preparation(1 day)
- Percentage of patients in whom there was complete visualization of the gastric surface in the antrum, body, and fundus and identification of the cardia and pylorus(1 day)
- Examination times of MCE and standard gastroscopy(1 day)
- Patient acceptance of MCE and standard gastroscopy(3 days)
- Adverse events of both procedures(2 weeks)
研究者
Zhaoshen Li
Director of Gastroenterology Dept.
Changhai Hospital