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临床试验/NCT02945137
NCT02945137已完成不适用

Comparison of Rapid Urease Test Between the Gastric Body and Antrum in Helicobacter Pylori-Infected Stomach

Soonchunhyang University Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2016年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
300
试验地点
1
主要终点
Positive reaction time of urease test

研究概览

简要总结

The accurate diagnosis of H. pylori infection is an important step for establishing the strategy for gastric cancer prevention. During endoscopy, rapid urease test (RUT) is the first of biopsy-based H. pylori tests. Despite indirect test for H. pylori detection, RUT shows rapid result with good sensitivity and specificity. Several study reported that H. pylori density was related to positive reaction time of RUT. However, there was no study comparing the positive reaction times of RUT according to biopsy site, degree of gastric atrophy, and intestinal metaplasia.

详细描述

The aims of this study were to: (1) assess the positive reaction times of RUT in the body and antrum, (2) investigate the association between the difference of RUT results (body and antrum) and gastric atrophy, and intestinal metaplasia, and (3) evaluate the optimal biopsy site for RUT according to degree of gastric atrophy in Korean population.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects who underwent upper endoscopy and rapid urease test

排除标准

  • : age < 20 or > 70 years; anemia (serum hemoglobin level < 10 g/dL); severe systemic disease or advanced chronic liver disease; use of certain medications, including proton pump inhibitors, H2-receptor antagonists, or antibiotics; a history of H. pylori eradication; a history of gastric surgery; a recent history of upper gastrointestinal bleeding.

结局指标

主要结局

Positive reaction time of urease test

时间窗: within 24 hours

Color change to red or pink means positivity

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jun-Hyung Cho

Assistant Professor

Soonchunhyang University Hospital

研究点 (1)

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