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临床试验/NCT04233684
NCT04233684已完成不适用

Rapid Urease Test for Helicobacter Pylori in Population Who Stop Proton Pump Inhibitor Less Than 2 Weeks Compared With Histology

King Chulalongkorn Memorial Hospital2 个研究点 分布在 1 个国家目标入组 67 人开始时间: 2019年8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
67
试验地点
2
主要终点
Sensitivity of rapid urease test for dectection of H.pylori from gastric antrum and body

研究概览

简要总结

Patients with dyspepsia will have negative impact to their life and common cause is Helicobactor pylori infection. Rapid urease test is the easy available and rapid method to test the infection but the test may be interfered by proton pump inhibitor, bismuth or antibiotics .In general, patients with dyspepsia usually take proton pump inhibitor to relieve dyspepsia so those patients may not stop the drug before test the infection with rapid urease test. So author aims to measure the sensitivity of rapid urease test from biopsy of body, which H. pylori would migrate if the patients still take proton pump inhibitor and biopsy of antrum, which is standard location of biopsy compare to pathology for H. pylori in each sites in patients who do not stop taking proton pump inhibitor

详细描述

The investigators contacted patients who had an appointment for esophagoendoscopy(EGD) at Chulalongkorn Hospital to inform and review patient's history. If patients matched inclusion and did not meet exclusion criteria, the participants would tell the information of the study including proposal, method, risk and benefit then the investigators asked for consent to participate in the study.

If patients decided to participate then the investigator corrected the information in CRF form which was sex, age, underlying disease, smoking history, alcohol drinking history, current and past medication especially PPI and NSIADs, EGD and rapid urease test history, H. pylori treatment history, duration of taking PPI drug.

EGD was done by endoscopist with standard method. The investigator performed biopsy at antrum, 5 cm proximal to pylorus lesser curvature, and body, greater curvature opposite to angularis by standard forceps. The biopsy would take 2 times from each site for rapid urease test and histopathology test for H. pylori. The endoscopists change forceps after finishing biopsy in each site to reduce contamination. The EGD finding was recorded After the investigators test H. pylori by rapid urease test, the result was read at 24 hours at room temperature. The color changing from yellow to pink was positive test, which mean there was H. pylori infection. In contrast, negative test was no color changing.

For Histopathologic test, the investigators fixed sample in formalin, infiltrated the tissue with paraffin then embedded. Stained with Hematoxylin & Eosin and looked for H. pylori by 2 histopathologists, who were blinded the result to each other and result of rapid urease test. If negative study, the histopathologists would stain tissue with giemsa and corrected data again. All gastric tissue will be sent for immunohistochemistry as a gold standard for this study.

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

盲法说明

The pathologists will be blinded for the result of endoscopic finding and rapid urease test.

入排标准

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

入选标准

  • Patients with dyspepsia and have indication for esophagogastroscopy
  • Patients who take PPI at least 2 weeks and stop the drug less than 2 weeks
  • Age above 18 years old

排除标准

  • Patients who diagnosed to have iron deficiency anemia and have signs of previously bleeding gastric ulcer
  • Active upper gastrointestinal bleeding or recent bleeding
  • previous gastric surgery
  • patients who take bismuth or antibiotic in last 4 weeks
  • Coagulopathy, INR>1.5, Platelet < 100,000
  • gastric cancer
  • Life expectancy less than 3 months
  • Deny to participate in the study

结局指标

主要结局

Sensitivity of rapid urease test for dectection of H.pylori from gastric antrum and body

时间窗: 24 hours after test by rapid urease test

The sensitivity of rapid urease test for H.pylori diagnosis at antrum, body and both in patients stopping proton pump inhibitors less than 2 weeks

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

Rapat Pittayanon

Principle investigator

King Chulalongkorn Memorial Hospital

研究点 (2)

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