NCT01262937终止不适用
A Pilot Study to Examine the Human Gastrointestinal Tract Using the Confocal Endomicroscope
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- To compare confocal image characteristics between benign and malignant tissue.
研究概览
简要总结
The goal of the project is to determine whether confocal endomicroscopy can be used to identify and discriminate among dysplastic, neoplastic, and nonneoplastic tissue, as compared with histologic specimens as a reference. The project will evaluate those at risk for or with known Barrett's esophagus, and those with known or suspected biliary strictures. It is our hypothesis that we will be able to identify between neoplastic and nonneoplastic tissue.
详细描述
This study was amended from it's initial design to increase the number of patients to 200. The study was terminated in July 2016 after 106 patients were enrolled and had completed the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with long-standing reflux symptoms, undergoing surveillance for Barrett's esophagus, or scheduled for endoscopic therapy with esophageal dysplasia
- •Patients undergoing ERCP for known or suspected biliary strictures.
排除标准
- •have a known allergy or have had a prior adverse reaction to fluorescent contrast agents or chromoendoscopy stains
- •are younger than age 18 or who are mentally or legally incapacitated or unable to give informed consent
- •are pregnant or breastfeeding
- •patients with advanced esophageal cancer
- •acute gastrointestinal bleeding
- •coagulopathy
- •impaired renal function
结局指标
主要结局
To compare confocal image characteristics between benign and malignant tissue.
时间窗: 2 Years
次要结局
未报告次要终点
研究者
研究点 (1)
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