Arrangement of Collecting Venules for the Endoscopic Diagnosis of Helicobacter Pylori (MOTIVATION)

February 28, 2023 updated by: Hospital Clinic of Barcelona

Arrangement of Collecting Venules for the Endoscopic Diagnosis of Helicobacter Pylori Infection (MOTIVATION): International Multicentre Study Outside Asia

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Training phase Before starting the inclusion of patients, 20 HD images previously collected by the principal investigator will be sent to each of the study investigators. Pictures will clearly show the RAC pattern present or absent at the level of the distal gastric lesser curvature. In case of doubtful RAC, the pattern shall be considered negative. Investigators will be able to discuss their questions and doubts after the training phase (videoconference).

Endoscopic examination Upper endoscopy will be performed with HD endoscopes and a high-definition screen. Two endoscopists will participate in each hospital. The examination will be performed according to the protocol of each centre. Visualisation of the entire oesophageal, gastric and duodenal surface will be performed as in routine clinical practice. The presence of RAC will be assessed during the gastric exploration with sufficient insufflation and its detection will be considered as the presence of a regular starfish-shaped erythematous punctation in the lower part of the lesser curvature of the gastric body, close to the incisura angularis.

In case of the presence of residues in the gastric cavity that prevent the correct visualisation of the area, water washings shall be performed for the correct characterisation of the mucosa. At least one photo of the described gastric region shall be taken with the image processor system to maintain its high-definition quality. All the data (name, date of birth, clinical record number, date of exploration…) will be removed from the picture to ensure the anonymisation. Subsequently, the photographs will be downloaded and saved in a folder on a network drive of each hospital.

After characterisation of the gastric mucosa, the Hp infection status will be assessed by taking biopsies with a standard forceps for anatomopathological study according to Sydney's protocol (2 in the antrum, 1 in the incisura and 2 in the body). Ideally, biopsies for a urease test will also be obtained.

Histopathological examination Samples shall be fixed in formalin and analysed by the Anatomical Pathology service for histological examination by haematoxylin and eosin (H&E) and special staining for Hp (e.g. modified Giemsa). In patients taking PPI, if Hp is negative in the H&E histological study, the study will be completed by immunohistochemical (IHC) staining.

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
      • Brussels, Belgium, 1080
        • Recruiting
        • Cliniques Universitaires Saint Luc
        • Contact:
  • Germany
    • Baviera
      • Munich, Baviera, Germany, 80331
        • Recruiting
        • München University Hospital
        • Contact:
          • Riccardo Vasapolli, MD
  • Spain
      • Barcelona, Spain, 08036
        • Recruiting
        • Hospital Clinic de Barcelona
        • Contact:
    • Badajoz
      • Mérida, Badajoz, Spain, 06800
        • Completed
        • Hospital de Merida
    • Barcelona
      • Viladecans, Barcelona, Spain, 08840
        • Active, not recruiting
        • Hospital de Viladecans

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
This is a prospective, multicentre, international study without a control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
RAC performance
Time Frame: 12 months

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Baseline characteristics
Time Frame: 12 months
To assess whether age, sex and PPIs, have an influence on the results of RAC in all patients.
12 months
Histological correlation
Time Frame: 12 months
To assess the correlation of atrophic gastritis and intestinal metaplasia (confirmed in histopathological samples) and RAC in all patients.
12 months
Reproducibility
Time Frame: 12 months
To assess reproducibility of RAC on real time examinations with different operators and in different countries with different Hp infection prevalence.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Clinic of Barcelona

Investigators

  • Principal Investigator: Gloria Fernandez-Esparrach, PhD, Hospital Clinic of Barcelona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2021

Primary Completion (Anticipated)

June 30, 2023

Study Completion (Anticipated)

September 30, 2023

Study Registration Dates

First Submitted

September 6, 2021

First Submitted That Met QC Criteria

September 13, 2021

First Posted (Actual)

September 16, 2021

Study Record Updates

Last Update Posted (Actual)

March 1, 2023

Last Update Submitted That Met QC Criteria

February 28, 2023

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCB-RAC-MOTIVATION

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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