NCT02863965Unknown不适用
High Definition Endoscopy and Optic Enhancement Endoscopy in Gastric Neoplasia: A Prospective Study
Shandong University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2016年3月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Positive predictive value of optical enhancement endoscopy in diagnosis of gastric neoplasia
研究概览
简要总结
The aim of the study is to evaluate the diagnostic value of high definition endoscopy and optic enhancement in gastric neoplasia.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •patients with dyspeptic symptoms and aged 40 years or older
- •or patients with Helicobacter pylori infection, or histologically verified gastric intestinal metaplasia or atrophic gastritis
- •or patients with family history of gastric cancer
排除标准
- •presence of gastrectomy, acute gastrointestinal bleeding, or known gastric neoplasia
- •presence of conditions unsuitable for endoscopy procedure including coagulopathy, impaired cardiopulmonary function , pregnancy or breastfeeding
- •inability to provide informed consent
结局指标
主要结局
Positive predictive value of optical enhancement endoscopy in diagnosis of gastric neoplasia
时间窗: 8 months
Sensitivity of optical enhancement endoscopy in diagnosis of gastric neoplasia
时间窗: 8 months
Specificity of optical enhancement endoscopy in diagnosis of gastric neoplasia
时间窗: 8 months
Negative predictive value of optical enhancement endoscopy in diagnosis of gastric neoplasia
时间窗: 8 months
次要结局
- The inter-observer and intra-observer agreement of optic enhancement endoscopy in gastric neoplasia(8 months)
研究者
Yanqing Li
Vice president of Qilu Hospital
Shandong University
研究点 (1)
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