NCT00449995已完成不适用
Confocal Laserscanning Microscopy for Detection of Barretts Esophagus. A Blinded Multi-Center Study.
Technical University of Munich2 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2007年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 73
- 试验地点
- 2
- 主要终点
- diagnostic accuracy of confocal laser scanning microscopy for detection of metaplasia or neoplasia in Barrett´s esophagus
研究概览
简要总结
Four quadrant biopsies in regular ranges is the goldstandard in monitoring this disease. The ideal situation for the endoscopist is to visualize cellular structures, which implies having microscopic imaging available. A potential candidate to fill this gap could be confocal fluorescence microscopy (Cellvizio®-GI and Mauna Kea Technologies). To compare the gold standard with the confocal fluorescence microscopy for detection of metaplastic - or intraepithelial neoplastic changes of barrett-suspicious esophageal mucosa this study has been initiated.
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
- Single
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 18 and 80 years
- •regular esophagogastroduodenoscopy for patients with known barrett esophagus (at least stadium C0M1)
- •patients presenting for endoscopic mucosectomy with intraepithelial neoplastic changes <1cm
- •patients presenting with suspected intraepithelial neoplastic changes
- •patients receiving acid suppressive therapy in standard dose for at least 4 weeks
排除标准
- •no informed consent
- •thrombocytopenia, quick <50%, PTT >50 sec
- •patients with coronary heart disease or existent valve plasties
- •women with potential pregnancy
- •patients with chronic renal failure
- •patients with allergies
- •patients with chronic obstructive pulmonary disease
结局指标
主要结局
diagnostic accuracy of confocal laser scanning microscopy for detection of metaplasia or neoplasia in Barrett´s esophagus
次要结局
- inter- and intra observer variability for confocal laser scanning microscopy
研究者
研究点 (2)
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