NCT05349578已完成不适用
A Prospective Comparison of Cotton Swab Method and Conventional Biopsy Sampling in Rapid Urease Test for Helicobacter Pylori Detection
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Accuracy
研究概览
简要总结
A randomized controlled trial for comparing the Helicobacter pylori test using the swap method and the method using the conventional biopsy.
详细描述
The aim of this study is to conduct a prospective study under the hypothesis that a cotton swab method in the rapid urease test is not inferior to the conventional biopsy.
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
- Double (Participant, Care Provider)
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
- •Adults aged 20-80
- •Patients who undergo esophagogastroduodenoscopy and need for investigation of Helicobacter pylori infection.
排除标准
- •Surgical history of any kind of gastrectomy
- •Patients with contraindication of esophagogastroduodenoscopy
研究组 & 干预措施
Tissue
Other
conventional RUT using biopsied tissue
干预措施: swab RUT (Diagnostic Test)
Swab
Experimental
RUT using swab
干预措施: swab RUT (Diagnostic Test)
结局指标
主要结局
Accuracy
时间窗: the same day wtih EGD
Accuracy of diagnosis for Helicobacter pylori infection
次要结局
- sensitivity, false positive, false negative rate, etc.(the same day wtih EGD)
研究者
Hyunsoo Chung
Associate Professor
Seoul National University Hospital
研究点 (1)
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