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NCT05046990: MOTIVATION

Arrangement of Collecting Venules for the Endoscopic Diagnosis of Helicobacter Pylori

Status unknown Last updated 1 March 2023
What this trial tests

trial testing Regular Arrangement of Collecting Venules in Helicobacter Pylori Infection in 1,000 participants. Status unknown.

Timeline
1 December 2021
Primary endpoint
30 June 2023
30 September 2023

Quick facts

Lead sponsorHospital Clinic of Barcelona
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment1,000
Start date1 December 2021
Primary completion30 June 2023
Estimated completion30 September 2023
Sites5 locations across Belgium, Germany, Spain

Drugs / interventions tested

Conditions studied

Sponsor

Hospital Clinic of Barcelona

Who can join

18 and older, any sex, with Helicobacter Pylori Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Regular arrangement of collecting venules as a predictor of <i>Helicobacter pylori</i> absence using white-light endoscopy: a multicenter prospective study outside Asia.
    Garcés-Duran R, Llach J, Delgado-Guillena P, Vasapolli R, et al · · 2025 · PMID 41321746 · DOI 10.1177/26317745251387183

Verify or expand the search:

Other recruiting trials for Helicobacter Pylori Infection

Currently open trials in the same condition.

Other Hospital Clinic of Barcelona trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05046990.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing