Usefulness of Dual-focus Magnification With Narrow-band Imaging in the Prediction of Helicobacter Pylori Infection: a Prospective Randomized Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 292
- 试验地点
- 2
- 主要终点
- Accurate prediction of Helicobacter pylori status
研究概览
简要总结
Dual-focus with narrow-band imaging (DF-NBI) is a novel technique to improve the quality of images of the irregular mucosal structures and microvessels of gastric neoplasms. The investigators compare this technique with conventional white light (WL) endoscopy to predict Helicobacter pylori infection.
详细描述
The subjects are patients who underwent upper gastrointestinal endoscopy under sedation. Participants are randomized into DF-NBI and WL groups. Rapid urease test will be performed in all cases. By captured images of gastric mucosa, classification of DF-NBI for Helicobacter pylori infected mucosa will be developed and validated. The established classification of WL for Helicobacter pylori infection will be used. Finally, the investigators will compare the accuracy between two groups based on each classification.
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
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •consecutive patients who have undergone uper gastrointestinal endoscopy for diagnosis or screening of cancer.
排除标准
- •Those whose Hp status had already been clarified
- •Pregnancy
- •History of partial gastrectomy
- •Taking proton pump inhibitor, antithrombotics or antibiotics within 4 weeks
研究组 & 干预措施
WL
Conventional white light endoscopy use It is routine practice for the upper gastrointestinal endoscopy.
干预措施: Dual focus with narrow band imaging (Device)
DF-NBI
Initially, gastric mucosa is observed by conventional wight light endoscopy. Then, converting to dual-focus mode with narrow band imaging is done. Gastric mucosa is observed once again by DF-NBI mode.
干预措施: Dual focus with narrow band imaging (Device)
结局指标
主要结局
Accurate prediction of Helicobacter pylori status
时间窗: 1 day
Sensitivity, specificity, PPV, and NPV
次要结局
未报告次要终点
研究者
Jung-Wook Kim
Professor
Kyunghee University Medical Center