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临床试验/NCT04489030
NCT04489030已完成不适用

Magnifying Narrow-band Imaging for Diagnosis of H. Pylori and Precancerous Gastric Conditions: Comparison With Standard Endoscopy

Soonchunhyang University Hospital1 个研究点 分布在 1 个国家目标入组 254 人开始时间: 2016年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
254
试验地点
1
主要终点
H. pylori infection status

研究概览

简要总结

Recently, the improved resolution with standard endoscopy allows the close observation of highly inflamed gastric mucosa without a magnifying view. In a previous study, the investigators established the endoscopic classification of H. pylori-infected stomach by non-magnifying standard endoscopy. One normal RAC pattern and three types of abnormal patterns were observed. Overall diagnostic accuracy for predicting H. pylori-infection was 91.6%. However, there is no comparison study predicting H. pylori-infection and precancerous gastric lesions between standard and magnifying endoscopy.

详细描述

The investigators aimed to evaluate the diagnostic efficacies of non-magnifying standard endoscopy for predicting H. pylori-infection status and precancerous gastric conditions, compared to magnifying NBI endoscopy

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

  • Gastroscopy can be performed
  • H. pylori test and pathological analysis can be performed

排除标准

  • Age < 20 or > 70 years
  • Anemia (serum hemoglobin level < 10 g/dL)
  • Severe systemic disease
  • Advanced chronic liver disease
  • Use of certain medications, including proton pump inhibitors, H2- receptor antagonists, or antibiotics
  • History of H. pylori eradication
  • History of gastric surgery
  • Recent history of upper gastrointestinal bleeding

结局指标

主要结局

H. pylori infection status

时间窗: 1 month

H. pylori positivity would be assessed using rapid urease test.

Degree of chronic gastritis

时间窗: 1 month

Gastric atrophy and intestinal metaplasia would be evaluated on the basis of histopathological examination (updated Sydney system).

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

Associate Professor

Soonchunhyang University Hospital

研究点 (1)

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