Development and Validation of a Predictive Model for Early Gastric Cancerous Lesions Under Endoscopic Observation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 主要终点
- Accuracy of the diagnostic model in histological prediction of gastric cancerous lesions
研究概览
简要总结
Without high diagnostic efficacy of endoscopic forceps biopsy (EFB) and with low diagnostic efficacy of narrow band imaging (NBI) in novice endoscopists and endoscopists of community hospitals in China, it is urgent to improve diagnostic efficacy for gastric cancerous lesions.The investigators will conduct a study to develop and validate a diagnostic model based on NBI for early gastric cancerous lesions under endoscopic observation.
详细描述
Endoscopic forceps biopsy (EFB) is considered the gold standard and most commonly used for histological diagnosis of gastric epithelial neoplasia before proper management.Many studies have shown that there exist considerable discrepancies between EFB and subsequently resected specimens with discrepancy rate of 27.1-44.5%. On the other hand, with low diagnostic efficacy of narrow band imaging (NBI) in novice endoscopists and endoscopists of community hospitals in China, not higher diagnostic accuracy of gastric cancerous lesions could be observed. Here, the investigators will conduct a study to develop and validate a diagnostic model based on narrow band imaging for early gastric cancerous lesions under endoscopic observation, trying to improve overall diagnostic efficacy for gastric cancerous lesions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Suspected of having a cancerous lesions
- •The age of patients is from 40-80 years
- •Patients must undergo esophagogastroduodenoscopy
排除标准
- •Clinical diagnosis of advanced gastric cancer
- •Acute upper gastrointestinal bleeding
- •Severe systemic diseases
- •Refuse to attend the study
研究组 & 干预措施
Suspected gastric cancerous lesions
Magnifying endoscopy with NBI would be conducted for every patient included in our study
干预措施: NBI (Device)
结局指标
主要结局
Accuracy of the diagnostic model in histological prediction of gastric cancerous lesions
时间窗: 36 months
次要结局
未报告次要终点
研究者
Xiaobo Li
Professor
Shanghai Jiao Tong University School of Medicine