Confocal Laser Endomicroscopy in Patients With Crohn´s Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To determine endomicroscopic features of Crohn´s disease.
研究概览
简要总结
Purpose:
The main objective of this study is to determine endomicroscopic features of Crohn´s disease.
Background:
Crohn´s disease is an inflammatory disease of the intestines that may affect any part of the gastrointestinal tract from anus to mouth, causing a wide variety of symptoms. Diagnosis is based on several histologic features including transmural pattern of inflammation, crypt abscesses and granulomas. 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 Crohn´s disease.
详细描述
Methods:
Patients underwent colonoscopy for the evaluation of Crohn´s disease. During the endoscopic procedure CLE will be performed.
Procedure:
The patient underwent colonoscopy. During the procedure the patient will receive intravenous fluorescein or topical mucosal staining with acriflavin or cresyl violet, followed by in-vivo CLE of the tissue. Confocal images are digitally saved and analyzed afterwards.
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 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 endomicroscopic features of Crohn´s disease.
时间窗: October 2009 until May 2010
次要结局
- Comparison of CLE findings with conventional histology.(October 2009 until May 2010)