Endofaster Test for Helicobacter Pylori Detection in Patients on Proton Pump Inhibitor Therapy: Prospective Validation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy of the EndoFaster test in H. pylori diagnosis
研究概览
简要总结
H. pylori infection is the most important causative agent of gastritis, and subsequent atrophic gastritis. The endoscopic diagnosis of H. pylori infection relies on urease tests such as the Clo test. However, treatment with proton pump inhibitors (PPI) impairs the diagnostic yeld of urease tests. The EndoFaster test (NISO BioMed, Turin, Italy) is a new technology that has the advantage, over conventional urease tests, of a real-time analysis of the gastric juice that can provide information regarding Helicobacter pylori infection and pH value of the gastric contents. A well designed clinical study is therefore warranted to fully assess the performance of the EndoFaster test in detecting H. pylori infection in patients treated with PPI. We aim to perform a clinical study in an adult population in United Kingdom in order to determine the diagnostic accuracy of the Endo Faster test compared to the Clo test, histological diagnosis and the faecal antigen test in evaluating H.pylori infection. Patients on PPI will undergo a gastroscopy with multiple biopsies and during the exam NISO Biomed EndoFaster test, as well as the Clo test, will be carried out. H. pylori faecal antigen test will also be performed and used as gold standard. Diagnostic accuracy of the different methods will be determined.
详细描述
Urease tests such as the Clo test for the diagnosis of Helicobacter pylori infection have been widely used because they are simple, cheap, and easy to carry out (1, 2). They can be performed during the endoscopic exam and give a relatively rapid result. However, treatment with proton pump inhibitors (PPI) may alter the result by changing the milieu where bacteria are present, especially in the antrum, by rendering it inhospitable with consequent decrease in the bacterial load. In addition, PPI themselves may have antiurease properties (3). Another reason for a false-negative result is the presence of intestinal metaplasia (4), which also corresponds to an inhospitable environment for Helicobacter pylori. EndoFaster test is a new technology that has the advantage, over conventional urease tests, of a real-time analysis of the gastric juice that can provide information regarding Helicobacter pylori infection and pH value of the gastric contents. Sensitivity, specificity, PPV and NPV of EndoFaster test for Helicobacter pylori infection resulted to be 98.5%, 87.6%, 84.4% and 98.8 %, respectively. This test may be more accurate than conventional urease tests in the diagnosis of Helicobacter pylori infection in subjects on PPI as indeed it should increase the analysed area, thereby allowing to evaluating the bacterial density in both the gastric antrum and corpus. No data are currently available about the performance of the EndoFaster test in subjects on PPI and a well-designed clinical study is warranted.
The main aim of our study is to conduct a comparative study with the NISO BioMed EndoFaster test, the urease-based test (Clo test), histologic diagnosis and the faecal antigen test (used as the gold standard) for the diagnosis of Helicobacter pylori infection in PPI-treated patients.
We will perform a clinical study using the NISO BioMed Endofaster test to diagnose Helicobacter pylori infection in patients on PPI therapy. The study will be conducted as a collaboration between NISO BioMed (Turin, Italy) and Homerton University Hospital (London, UK). The study will be performed at the Homerton Hospital.
One hundred patients on PPI will be enrolled among the patients with dyspepsia referred for gastroscopy at Homerton University Hospital (London, United Kingdom). A control group of 50 patients with dyspepsia, not on PPI, will be also enrolled in the study.
On the day of the endoscopic procedure the patients will bring a stool sample for the detection of Helicobacter pylori antigen. Subsequently, a gastroscopy with multiple biopsies will be performed and during the exam NISO Biomed EndoFaster test, as well as the Clo test, will be carried out.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult females and males over 45 years of age with dyspeptic symptoms (epigastric pain, bloating and epigastric discomfort)
排除标准
- •Patients who require surgery or immediate follow-up treatment for major symptoms, including hematemesis, melena, acute epigastric pain
- •Patients who previously underwent upper gastrointestinal surgery
- •Patients with diabetes
- •Pregnant women
- •Subjects who refuse to participate or are unable to give consent
结局指标
主要结局
Diagnostic accuracy of the EndoFaster test in H. pylori diagnosis
时间窗: Six weeks
Clinical specialist consultation will be performed and eligible patients will be enrolled and candidate to undergo a gastroscopy. On the day of the endoscopic procedure the patients will bring a stool sample for the detection of Helicobacter pylori antigen. Subsequently, a gastroscopy with multiple biopsies will be performed and during the exam NISO Biomed EndoFaster test, as well as the Clo test, will be carried out. Performance indicators (sensitivity, specificity, positive predictive value, PPV, negative predictive value, NPV and their 95%CI) of the EndoFaster test will be calculated, using the STATA/SE software. The area under ROC (Receiver Operating Characteristics) called AUC, will be identified. These ROC curves can be used to identify the optimal sensitivity/specificity balance that gives each biomarker an optimal threshold for detection of each study endpoint. Significance of the difference between AUC values can be estimated using STATA's roccomb test with 95%CI.
次要结局
未报告次要终点