NCT01234376已完成不适用
Confocal Laser Endomicroscopy in Patients With Eosinophilic Esophagitis
University of Erlangen-Nürnberg Medical School1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2010年11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
- 45
- 试验地点
- 1
- 主要终点
- Effectiveness of endomicroscopy for the in vivo diagnosis of eosinophilic esophagitis
研究概览
简要总结
Confocal laser endomicroscopy enables in vivo microscopic imaging within the mucosa layer of the gut at a subcellular resolution. Various studies have addressed the potential of endomicroscopy for the in vivo diagnosis of esophageal squamous cell carcinoma, Barrett´s esophagus and esophageal adenocarcinoma. Currently, there is only one case report from our group who noted the utility of endomicroscopy for the in vivo diagnosis of eosinophilic esophagitis.
The purpose of this study is to determine whether endomicroscopy is effective for the in vivo diagnosis of eosinophilic esophagitis.
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
- 是
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 EGD
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
Effectiveness of endomicroscopy for the in vivo diagnosis of eosinophilic esophagitis
时间窗: November 2010 - November 2012
次要结局
- Differentiation of mucosal alterations in patients with eosinophilic esophagitis compared to patients with gastroesophageal reflux disease.(November 2010 - November 2012)
研究者
研究点 (1)
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