NCT00851305已完成不适用
Comparison Confocal Laser Endomicroscopy With Conventional Endoscopy for the Detection of Early Gastric Cancers
Shandong University1 个研究点 分布在 1 个国家目标入组 1,786 人开始时间: 2008年8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
- 1,786
- 试验地点
- 1
- 主要终点
- To compare the rate of EGCs/GCs using CLE versus conventional gastroscopy.
研究概览
简要总结
The purpose of this study is to determine whether endomicroscopy can improve the detection of Early Gastric Cancers (EGC).
详细描述
Endoscopy is proved to be the best method to achieve early diagnosis of gastric cancer (GC). Confocal laser endomicroscopy (CLE), a new diagnostic modality, has been shown to be valuable in increasing the diagnostic yield of colorectal neoplasias, but it is not clear whether CLE is helpful to find out early gastric cancer (EGC).The aim of the study is to investigate the value of CLE in improving the detection of EGCs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •45 years old ≤ age < 80 years old
- •Patients with dyspeptic symptoms or with gastric premalignant conditions for surveillance gastroscopy
排除标准
- •Known cancers or gastrectomy
- •Scheduled for endoscopic treatment
- •Alarm symptoms such as dysphagia, anaemia, gastrointestinal bleeding or obstruction, marked weight loss
- •Under conditions such as:
- •liver cirrhosis
- •impaired renal function
- •coagulopathy
- •pregnancy
- •breastfeeding
- •Inability to provide informed consent
- •Known allergy to fluorescein sodium
结局指标
主要结局
To compare the rate of EGCs/GCs using CLE versus conventional gastroscopy.
时间窗: one year
次要结局
- To evaluate the efficacy of in vivo CLE on different pathological characteristics of EGCs.(one year)
研究者
Yanqing Li
Chief of the Department of Gastroenterology
Shandong University
研究点 (1)
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