NCT05046990

Brief 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

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2021

Geographic Reach
3 countries

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 6, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 16, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

March 1, 2023

Status Verified

December 1, 2022

Enrollment Period

1.6 years

First QC Date

September 6, 2021

Last Update Submit

February 28, 2023

Conditions

Helicobacter Pylori Infection

Outcome Measures

Primary Outcomes (1)

  • RAC performance

    A total of 1000 consecutive patients with no history of Hp who come for gastroscopy will be included in the study to perform a prospective, observational, international, multicentre, in vivo study to assess the performance of regular arrangement of collecting venules (RAC). Endoscopists will perform a training test with 20 pictures of the distal part of the lesser curvature before starting the inclusion of cases. 17 different centers will participate in the study and each of them will include between 50 and 100 patients. Presence of RAC using white light high definition endoscopy without magnification determines the exclusion of Helicobacter pylori (Hp) infection. Gold standard diagnosis test for Hp infection will be histological results by 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).

    12 months

Secondary Outcomes (3)

  • Baseline characteristics

    12 months

  • Histological correlation

    12 months

  • Reproducibility

    12 months

Study Arms (1)

RAC evaluation

Patients older than 18 years without previous history of Hp infection or eradication undergoing a gastroscopy

Diagnostic Test: Regular Arrangement of Collecting Venules

Interventions

Regular Arrangement of Collecting VenulesDIAGNOSTIC_TEST

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

RAC evaluation

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients older than 18 years without previous history of Hp infection or eradication undergoing a gastroscopy in each center

You may qualify if:

  • Patients older than 18 years without previous history of Hp infection or eradication undergoing a gastroscopy

You may not qualify if:

  • Patients taking oral anticoagulants (acenocoumarol and new anticoagulants as dabigatran, rivaroxaban, apixaban and edoxaban), NSAIDs or with intake of antibiotics in the last 4 weeks, but aspirin at a dose of 100 mg per day will be included
  • Diseases that affect the gastric mucosa and preclude the evaluation of the collecting venules pattern (portal hypertension, gastric lymphoma)
  • History of previous gastric cancer or patients in surveillance for preneoplastic lesions (atrophic gastritis/IM),
  • Previous gastric surgery,
  • Active bleeding or presence of blood or food that would impede a complete mucosal evaluation.
  • Negative to participate in the study or inability to provide signed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Cliniques Universitaires Saint Luc

Brussels, 1080, Belgium

RECRUITING

München University Hospital

Munich, Bavaria, 80331, Germany

RECRUITING

Hospital de Mérida

Mérida, Badajoz, 06800, Spain

COMPLETED

Hospital de Viladecans

Viladecans, Barcelona, 08840, Spain

ACTIVE NOT RECRUITING

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

RECRUITING

Related Publications (2)

  • Garces-Duran R, Galdin-Ferreyra M, Delgado-Guillena PG, Cuatrecasas M, Cordova H, Garcia-Rodriguez A, Rodrigo-Calvo MT, Jimeno-Ramiro M, Araujo IK, Gines A, Llach J, Fernandez-Esparrach G. Diagnosis of Helicobacter pylori Infection by the Arrangement of Collecting Venules Using White Light Endoscopy: Evaluation of Interobserver Agreement. Dig Dis. 2022;40(3):376-384. doi: 10.1159/000518100. Epub 2021 Jun 30.

    PMID: 34348294BACKGROUND

  • Garces-Duran R, Garcia-Rodriguez A, Cordova H, Cuatrecasas M, Gines A, Gonzalez-Suarez B, Araujo I, Llach J, Fernandez-Esparrach G. Association between a regular arrangement of collecting venules and absence of Helicobacter pylori infection in a European population. Gastrointest Endosc. 2019 Sep;90(3):461-466. doi: 10.1016/j.gie.2019.05.027. Epub 2019 May 17.

    PMID: 31108089BACKGROUND

Study Officials

  • Gloria Fernandez-Esparrach, PhD

    Hospital Clinic of Barcelona

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gloria Fernandez-Esparrach, PhD

CONTACT

+34932275400mgfernan@clinic.cat

Rodrigo Garces-Duran, MD

CONTACT

+34932275400rodrigogduran@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2021

First Posted

September 16, 2021

Study Start

December 1, 2021

Primary Completion

June 30, 2023

Study Completion

September 30, 2023

Last Updated

March 1, 2023

Record last verified: 2022-12

Locations

ES(3)BE(1)DE(1)