Confocal Laser Endomicroscopy in Digestive Diseases
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Diagnostic yield for neoplasia of CLE vs. standard endoscopy
研究概览
简要总结
Confocal laser endomicroscopy (CLE) is a newly endoscopic device that enables microscopic view of the digestive tract. The purpose of this study is to determine if confocal laser endomicroscopy can improve detection of digestive disease include inflammation, dysplasia, and early cancer, and if confocal laser endomicroscopy has competitive advantage, compared with other device such as Narrow Band Imaging and Autofluoresecence Imaging.
详细描述
Advances in endoscopy have led to imagining of the details of digestive mucosa. Novel techniques such as Narrow Band Imaging (NBI) assisted magnification endoscopy, Auto Fluorescence Imaging (AFI) or confocal laser endomicroscopy could, however, improve the endoscopic detection.In this research we describe the combined use of these three techniques in patients with digestive disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects over 18 years of age
- •Subjects undergoing endoscopic procedures such as gastroscopy, colonoscopy, endoscopic retrograde cholangiopancreatography and endoscopic ultrasound will all be included
排除标准
- •Under 18 years of age.
- •Pregnancy or breast feeding
- •Allergy to the fluorescent contrast agent fluorescein sodium
- •Coagulopathy or bleeding disorder
- •In emergency or life-threatening situations(eg. acute gastrointestinal hemorrhage, and gastrointestinal obstruction or perforation)
- •impaired renal function, allergic asthma,
- •Cognitively impaired.
- •Residing in institutions (eg. prison, extended care facility)
- •Have language barriers (eg. illiterate, dysphasic)
结局指标
主要结局
Diagnostic yield for neoplasia of CLE vs. standard endoscopy
时间窗: one year
次要结局
- Diagnostic yield for neoplasia of CLE vs. NBI/AFI(one year)