Confocal Laser Endomicroscopy in the Digestive Tract: A Multicentre French Pilot Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 10
- 主要终点
- To establish a safe and standardized practice of CLE in France, which should give a possibility, by providing high quality optical biopsies, to perform in vivo diagnosis of different digestive diseases
研究概览
简要总结
Confocal laser endomicroscopy (CLE) is a new diagnostic technique that allows microscopic examination of the digestive mucosa during ongoing endoscopy. Different types of tissue and diseases can be diagnosed immediately, and analysis of the in vivo microarchitecture is helpful to better target standard biopsies and reduce the number of biopsies required. CLE necessitates an intravenous injection of a fluorescent marker, e.g. fluorescein, to obtain 'optical biopsies' with a high level of magnification (up to 1000 fold). To date, more than 1000 endomicroscopy procedures have been performed in the world and different publications have shown the safety, feasibility and excellent diagnostic yield of CLE. No complication related to IV injection of fluorescein has been reported. However, all these data come from a very limited number of expert centres and need to be confirmed and validated at the multicenter level. The aims of this multicenter trial are: 1) to standardize CLE in all centres equipped in France, 2) to ensure the safety of intravenous fluorescein injection, 3) to test the diagnostic value of CLE in various conditions representative of the large spectrum of different cancerous and non-cancerous digestive diseases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
To establish a safe and standardized practice of CLE in France, which should give a possibility, by providing high quality optical biopsies, to perform in vivo diagnosis of different digestive diseases
次要结局
- To assess the tolerance of CLE in terms of frequency and gravity of potential adverse events related to the injection of fluorescein
- To assess the diagnostic yield of CLE in various clinical conditions (cancerous and non-cancerous diseases) by comparing optical biopsies with standard histology
- To assess the interobserver agreement for this technique, using a database of optical biopsies created at the end of the study
