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临床试验/NCT01434992
NCT01434992已完成不适用

Detection of Helicobacter Pylori Infection by Non-magnifying High Resolution Endoscopy is Possible Within the Gastric Corpus

Kyunghee University Medical Center1 个研究点 分布在 1 个国家目标入组 585 人开始时间: 2011年8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
585
试验地点
1
主要终点
Diagnosis accuracy for predicting of Helicobacter pylori infection status

研究概览

简要总结

Although endoscopic findings of H. pylori have been reported in the literature, there is still some debate over whether H. pylori-related gastritis can be diagnosed via endoscopic features alone. Most studies concluded that it is not possible to diagnose H. pylori-related gastritis on the basis of endoscopic findings. However, the resolution power of endoscopy has greatly improved in recent years and the exact examination of gastric mucosa was possible.

详细描述

Our study aimed to achieve the following: (1) describe the H. pylori-related mucosal pattern in the gastric corpus using high-definition endoscopy; (2) evaluate the diagnostic accuracy for H. pylori detection; (3) find the optimal biopsy site for rapid urease test (RUT); (4) validate the inter- and intraobserver agreement in the assessment of endoscopic patterns.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Patients who underwent upper endoscopy

排除标准

  • Age < 20 or > 70
  • Severe systemic disease or advanced chronic liver disease
  • Medication history of NSAID, PPI, H2 blockers or antibiotics
  • History of H. pylori eradication therapy
  • History of gastric surgery
  • Recent history of upper GI bleeding
  • Gastric or duodenal ulcer (including old scar change) during endoscopy
  • Anemia (Hemoglobin level < 10mg/dL)
  • Pangastritis

结局指标

主要结局

Diagnosis accuracy for predicting of Helicobacter pylori infection status

时间窗: 1 day

次要结局

  • Assessment of the clinicopathologic factors related to correct diagnosis(7 days)

研究者

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

Jun-Hyung Cho

Clinical and research fellow

Kyunghee University Medical Center

研究点 (1)

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