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Arrangement of Collecting Venules for the Endoscopic Diagnosis of Helicobacter Pylori

NCT05046990 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2023-03-01

No results posted yet for this study

Summary

To perform a prospective, observational, international, multicentre, in vivo study to assess the performance of regular arrangement of collecting venules (RAC) for the exclusion of Helicobacter pylori (Hp) infection using white light high definition (HD) endoscopy without any kind of zoom or magnification.

Gold standard will be mucosal biopsies (Sydney protocol) or urease test. Immunohistochemistry (IHC) should be performed in case of a negative histologic study for Hp in patients taking proton pump inhibitors (PPIs).

Participants will perform a training test with 20 pictures of the distal part of the lesser curvature before starting the inclusion of cases.

Secondary objectives are:

* To assess whether age, sex and PPIs, have an influence on the results of RAC.
* To assess the correlation of atrophic gastritis and intestinal metaplasia (confirmed in histopathological samples) and RAC.
* To assess reproducibility of RAC on real time examinations with different operators and in different countries with different Hp infection prevalence.

Primary and secondary variables

The primary study variable is:

\- Endoscopic detection of RAC.

Secondary variables will be considered:

* Sex
* Age
* PPI intake in the last two weeks
* Centre
* Country
* Hp prevalence
* Endoscopist
* Type of endoscope
* Significant findings (need of histological confirmation)

* Atrophic gastritis
* Intestinal metaplasia
* Erosive gastritis
* Benign gastric ulcer
* Gastric adenoma
* Gastric cancer

Conditions

  • Helicobacter Pylori Infection

Interventions

DIAGNOSTIC_TEST

Regular Arrangement of Collecting Venules

This is a prospective, multicentre, international study without a control group.

Sponsors & Collaborators

  • Hospital Clinic of Barcelona

    lead OTHER

Principal Investigators

  • Gloria Fernandez-Esparrach, PhD · Hospital Clinic of Barcelona

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2023-06-30
Completion
2023-09-30

Countries

  • Belgium
  • Germany
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05046990 on ClinicalTrials.gov