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临床试验/NCT02806115
NCT02806115Unknown1 期

The Efficacy of Severe Whitening and Delayed Fading in Acetic Acid-enhanced Endoscopy for Diagnosing Gastric Intestinal Metaplasia

Shandong University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
发起方
入组人数
100
试验地点
1
主要终点
accuracy of "severe whitening" for diagnosing gastric intestinal metaplasia

研究概览

简要总结

Investigators found that the degree and the duration of aceto-whitening differed between gastric intestinal metaplasia(GIM) and the surrounding normal mucosa: the area of GIM showed a severe degree of aceto whiteness and the whitening continued longer than the surrounding normal mucosa, which investigators called "severe whitening" and "delayed fading", and investigators realized that GIM could possibly be diagnosed by using these differences.The aim of this prospective study was to investigate the efficacy of "severe whitening" and "delayed fading" for diagnosing GIM.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • long-lasting upper gastrointestinal symptoms (>15 years)
  • atrophic gastritis or GIM identified at surveillance endoscopy

排除标准

  • presence of advanced adenocarcinoma in the stomach
  • presence of acute gastrointestinal bleeding
  • presence of coagulopathy, uncontrolled impaired renal or liver disease
  • presence of pregnancy or lactation
  • presence of allergy to acetic acid
  • age younger than 18 years or older than 80 years
  • inability to provide written informed consent.

研究组 & 干预措施

acetic acid-enhanced endoscopy

Experimental

Acetic acid-enhanced endoscopy combines conventional endoscopy with the instillation of acetic acid.

干预措施: acetic acid-enhanced endoscopy (Procedure)

acetic acid-enhanced endoscopy

Experimental

Acetic acid-enhanced endoscopy combines conventional endoscopy with the instillation of acetic acid.

干预措施: Acetic Acid (Drug)

acetic acid-enhanced endoscopy

Experimental

Acetic acid-enhanced endoscopy combines conventional endoscopy with the instillation of acetic acid.

干预措施: endoscope (Device)

结局指标

主要结局

accuracy of "severe whitening" for diagnosing gastric intestinal metaplasia

时间窗: 6 months

accuracy of "delayed fading" for diagnosing gastric intestinal metaplasia

时间窗: 6 months

次要结局

未报告次要终点

研究者

发起方
Shandong University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xiuli Zuo

director of Qilu Hospital

Shandong University

研究点 (1)

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