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临床试验/NCT04000243
NCT04000243已完成不适用

Interobserver Agreement of Endoscopic Diagnosis of Helicobacter Pylori Based on the Arrangement of Gastric Collecting Venules: Prospective and Multicenter Study

Hospital Clinic of Barcelona1 个研究点 分布在 1 个国家目标入组 164 人开始时间: 2019年7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
164
试验地点
1
主要终点
Performance characteristics of a regular pattern of collecting venules (RAC) for the diagnosis of infection by Helicobacter pylori

研究概览

简要总结

Helicobacter pylori (Hp) is the major cause of gastritis and gastritis-associated diseases. Detection of a regular arrangement of collecting venules (RAC) pattern in the lesser gastric curvature correlates with negative Hp status with a sensitivity and negative predictive value (NPV) higher than 90% in Asian countries.

In a recent study carried out in our hospital, it has been shown that the presence of RAC pattern in the lesser gastric curvature, evaluated with high definition endoscopy, can accurately identify patients without Hp.

The aim of this study is to confirm the validity of the endoscopic diagnosis of Hp infection in the West by means of the RAC pattern in a multicenter prospective study and to evaluate interobserver variability before establishing its applicability in clinical practice.

详细描述

We designed a prospective study including patients who will undergo upper gastrointestinal endoscopy from July 2019 to June 2020 at the Endoscopy Unit of Hospital Clinic of Barcelona.

The Ethics Committee of Hospital Clinic of Barcelona approved the study.

Upper gastrointestinal endoscopies will be performed with high definition endoscopes (Olympus, Germany) without magnification by three endoscopists. One of the endoscopists is considered as an expert with more than 20 years of experience and prior training in Japanese centers. All the examinations will be performed with sedation controlled by an anesthesiologist. After the routine examination of the esophagus, stomach, and duodenum, close observation will be carried out at the distal part of the lesser curvature and pictures will be taken. The Olympus system will be used for image storing and text reporting.

The presence of a regular or irregular arrangement of collecting venules will be evaluated in real time during gastric exploration in the lower part of the lesser curvature of the gastric body with good insufflation, close to the incisura angularis. If minute red points were visible regularly and homogenously, the finding will be scored as RAC positive (RAC+). If this finding was absent or there was a patchy distribution at the site of close observation, it will be defined as RAC negative (RAC-).

The following baseline characteristics will be collected: age, sex, antibiotics, proton-pump inhibitors, non-steroidal anti-inflammatory drugs (NSAIDs), antithrombotic or anticoagulant use in the last two weeks, history of Hp eradication and detection of significant endoscopic findings (erosive duodenitis, non-erosive duodenitis, duodenal ulcer, erosive gastritis, gastric ulcer and signs of atrophic gastritis or intestinal metaplasia).

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients older than 18 years who have an upper gastrointestinal endoscopy

排除标准

  • Taking antibiotics in the last 4 weeks
  • Presence of alimentary or hematic remains that prevent the correct visualization of the mucosa
  • Bleeding from the upper gastrointestinal tract
  • History of portal hypertensive gastropathy or lymphoma
  • History of partial or total gastrectomy
  • Refusal to participate

结局指标

主要结局

Performance characteristics of a regular pattern of collecting venules (RAC) for the diagnosis of infection by Helicobacter pylori

时间窗: one year

Number of patients with RAC / no RAC and infection by Helicobacter pylori

次要结局

  • Interobserver variability for the diagnosis of RAC(one year)
  • Accuracy of RAC in patients treated with proton pump inhibitors(one year)

研究者

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

Ana García-Rodríguez

Co-investigator (collaborator)

Hospital Clinic of Barcelona

研究点 (1)

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