Confocal Laser Endomicroscopy in Patients With Diarrhea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 主要终点
- To determine the frequency of different gastrointestinal disorders as the cause of diarrhea in patients at a tertiary referral center using confocal laser endomicroscopy.
研究概览
简要总结
The main objective of this study is to determine the frequency of different gastrointestinal disorders as the cause of diarrhea in patients at a tertiary referral center using confocal laser endomicroscopy.
详细描述
Background:
Diarrhea is characterized by frequent, loose, and watery bowel movements. Common causes include various gastrointestinal infections (e.g. clostridium difficile, salmonella), inflammatory bowel disease (ulcerative colitis, Crohn´s disease), drugs (e.g. antibiotics) and malabsorption syndromes (e.g. celiac and Whipple's disease). Confocal laser endomicroscopy (CLE) is rapidly emerging as a valuable tool for gastrointestinal endoscopic imaging, enabling the endoscopist to obtain an "optical biopsy" of the gastrointestinal mucosa during the endoscopic procedure.
Scope:
In patients with diarrhea.
Methods:
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Age 18-85 years
- •Ability of subjects to understand character and individual consequences of clinical trial
- •Subjects undergoing colonoscopy
排除标准
- •Inability to provide written informed consent
- •Severe Coagulopathy (Prothrombin time < 50% of control, Partial thromboplastin time > 50 s)
- •Impaired renal function (Creatinine > 1.2 mg/dl)
- •Pregnancy or breast feeding
- •Active gastrointestinal bleeding
- •Known allergy to fluorescein, acriflavin or cresyl violet
- •Residing in institutions (e.g. prison)
结局指标
主要结局
To determine the frequency of different gastrointestinal disorders as the cause of diarrhea in patients at a tertiary referral center using confocal laser endomicroscopy.
时间窗: February 2012
次要结局
- To investigate whether CLE has a higher sensitivity and specificity than standard colonoscopy in the diagnosis of the cause of diarrhea.(February 2012)