NCT02238665已完成不适用
CLE for Differential Diagnosis of IBD
University of Erlangen-Nürnberg Medical School1 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2009年10月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Number of participants with IBD
研究概览
简要总结
Differential diagnosis between Ulcerative Colitis (UC) and Crohn's disease (CD) is of pivotal importance for the management of Inflammatory Bowel Disease (IBD) as both entities involve specific therapeutic management strategies. Confocal Laser Endomicroscopy (CLE) allows on demand in vivo characterization of architectural and cellular details during endoscopy. Here, we assessed the efficacy of CLE to differentiate between UC and CD.
研究设计
- 研究类型
- Observational
- 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
- •equal or above 18 years of age
- •ability to provide written informed consent
- •well-established diagnosis of CD or UC
排除标准
- •history of IBD reclassification in the last 3 years
- •Boston Bowel Preparation Scale score's < 2 in at least one of the three broad regions of the colon (i.e. rectum plus left side colon, transverse colon plus left and right flexures, right colon)
- •inability to provide written informed consent
- •severe uncontrolled coagulopathy
- •impaired renal function
- •pregnancy or breast feeding
- •active gastrointestinal bleeding
- •known allergy to fluorescein
- •residence in institutions
结局指标
主要结局
Number of participants with IBD
时间窗: 4 years
次要结局
未报告次要终点
研究者
Helmut Neumann
Professor
University of Erlangen-Nürnberg Medical School
研究点 (1)
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