Acetic Acid Chromoendoscopy for Judging Extent of Gastric Intestinal Metaplasia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- Percent Agreement Between Acetic Acid Chromoendoscopy and Endoscopic Biopsy
研究概览
简要总结
The presence and the extent of gastric intestinal metaplasia(IM) is a good indicator of high risk group of gastric cancer. Many methods was developed to survey it, including multiple gastric biopsy or methylene blue chromoendoscopy. But they are not practical in the routine screening exam, limited by cost and accessibility. Spraying of acetic acid is commonly used in screening cervical cancer, to induce whitish discoloration of metaplastic mucosa. The investigators have confirmed such whitish discoloration is induced in gastric IM, with accuracy > 80% in a pilot study of the investigators. This prospective study will tell the accuracy, sensitivity and specificity of acetic acid chromoendoscopy for judging gastric IM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Person who undergo gastroduodenoscopy
- •Person who visit Konyang University Hospital
排除标准
- •Bleeding diathesis
- •History of stomach neoplasms
- •History of upper gastrointestinal surgery
结局指标
主要结局
Percent Agreement Between Acetic Acid Chromoendoscopy and Endoscopic Biopsy
时间窗: 3 months after the completion of the study (a pathologist reviewed all the biopsy slide)
Endoscopist judges the presence and the extent of gastric intestinal metaplasia during acetic acid chromoendoscopy. Endoscopist perform five endoscopic biopsies according to the protocol. The degree of agreement between the chromoendoscopy and the endoscopic biopsy is assessed as %.
次要结局
- Number of Participants With Adverse Events(up to 1week after the acetic acid chromoendoscopy)
- Agreement of Acetic Acid Chromoendoscopic Reading Between the Two Endoscopists(One month after the completion of the study)
研究者
Kyung Ho Song, MD
Assistant Professor
Konyang University Hospital