Diagnosis of Helicobacter Pylori Based on Gastric Collecting Venules

NCT04000243 | Completed

• 1 other identifier: RAC-M
• Study Type: observational
• Target: 164
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Helicobacter Pylori Infection; Upper Endoscopy; Regular Arrangement of Collecting Venules

Outcome Measures

Primary Outcomes (1)

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

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

  one year

Secondary Outcomes (2)

• Interobserver variability for the diagnosis of RAC

  one year

• Accuracy of RAC in patients treated with proton pump inhibitors

  one year

Interventions

Endoscopic diagnosis of Hp DIAGNOSTIC_TEST

Detection of a regular arrangement of collecting venules (RAC) pattern in the lesser gastric curvature

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients older than 18 years who have an upper gastrointestinal endoscopy that do not meet the exclusion criteria

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (1)

Hospital Clinic of Barcelona

Barcelona, 08036, Spain

Location

Study Officials

• Gloria Fernandez-Esparrach, PhD

  Hospital Clinic of Barcelona

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-investigator (collaborator)

Study Record Dates

• First Submitted: June 21, 2019
• First Posted: June 27, 2019
• Study Start: July 1, 2019
• Primary Completion: July 1, 2020
• Study Completion: December 31, 2020
• Last Updated: March 1, 2023

Record last verified: 2023-02

Locations

ES (1)