Evaluation of Image Quality Over Time After Injection of the fluorescein Sodium for Confocal Laser Endomicroscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The ideal time period for the best CLE imaging when using fluorescein sodium is about 10 minutes
研究概览
简要总结
Confocal laser endomicroscopy (CLE) is a newly developed endoscopic technique. The most commonly used fluorescent substance is Fluorescein sodium.The plasma half-life of fluorescein is 11 minutes. A recent test estimated that fluorescein-based CLSM(confocal laser scanning microscopy) of the upper-GI tract of pigs delivers the best contrast and image quality within the first 8 minutes after injection of fluorescein .However, despite its increasing use in clinical examination,there are no data on contrast dynamics and image quality over time after injection of the fluorescein sodium in the inspection of gastrointestinal tract of human being.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •These subjects will include male or female aged between 18 and 60 years with indications for upper-endoscopy ,but without serious gastritis and other serious stomach lesions
排除标准
- •Complications such as gastric and/or duodenal peptic ulcer, stenosis
- •Esophageal, gastric or duodenal cancer or other malignancy
- •History of stomach surgery
- •A history of bronchial asthma, or known allergy to fluorescein.
- •Pregnant or breast-feeding (for females)
- •Below 18 or above 60 years of age
- •Severe comorbidities ( e.g. such as renal failure, congestive cardiac failure, liver cirrhosis).
结局指标
主要结局
The ideal time period for the best CLE imaging when using fluorescein sodium is about 10 minutes
时间窗: Within the 30 minutes after injection of fluorescein
次要结局
未报告次要终点
研究者
Yanqing Li
Chief of the Department of Gastroenterology, Qilu Hospital
Shandong University