a Prospective Study on the Efficacy of Magnifying Endoscopy With Narrow-band Imaging in Diagnosing Gastric Lesions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 146
- 主要终点
- diagnosis accuracy of ME-NBI
研究概览
简要总结
Magnifying endoscopy with narrow-band imaging (ME-NBI) can emphasize surface pattern and microvascular architecture of the gastric mucosa.However,the usefulness and criteria of NBI for differential diagnosis among early gastric cancers (EGC) have not been fully established.The study is based on the hypothesis:
- ME-NBI is useful in distinguishing EGC from other gastric lesions
- ME-NBI is useful in further differential diagnosis among EGCs.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with gastric lesions which were detected by conventional screening endoscopy and suspected of early malignancy.
排除标准
- •advanced gastric cancer or any other malignancy;
- •patients under unsuitable conditions for examination or treatment, such as acute upper gastrointestinal bleeding, noncorrectable coagulopathy, severe systemic disease, etc;
- •inability to provide informed consent;
- •inability to provide histology of resected specimens after endoscopic treatment or surgery.
结局指标
主要结局
diagnosis accuracy of ME-NBI
时间窗: in 2 weeks after ME-NBI examination
ME-NBI diagnosis was made during real-time endoscopy procedure and reviewed in two weeks after ME-NBI examination. Sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of ME-NBI diagnosis compared with histology were measured.
次要结局
未报告次要终点
研究者
Xiaobo Li
Shanghai Institute of Digestive Disease，Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai Jiao Tong University School of Medicine