An observational study in Chronic; Gastritis, Atrophic, sponsored by Clinical Hospital Colentina. Recruiting at 2 sites in 2 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-09.
Sponsored by Clinical Hospital Colentina · Observational
This prospective multicenter study investigates the added benefit of incisura biopsy to correct identification of patients with high-risk chronic gastritis (OLGA stages III-IV). It compares a biopsy protocol with and without a single incisura biopsy in a non-inferiority design. Anonymized photo and videodocumentation according to institution practices will constitute a databank for lesion recognition, quality improvement, and potential AI development.
The investigators will perform a prospective, multicenter, randomized controlled trial of 2 different gastric biopsy protocols. The hypothesis is that a gastric mapping protocol not including the incisura biopsy ("I-": 2 biopsies from the antrum, 2 from the corpus) is non-inferior to the conventional 5-biopsy approach ("I+": 2 biopsies from the antrum, 2 from the corpus, 1 from the incisura). The primary endpoint of this study is to assess the sensitivity of the "I-" protocol in diagnosing high-risk precancerous chronic gastritis (OLGA/OLGIM stages III or IV) compared to the assumed gold standard of histology based on the "I+" protocol.
In designing the study, the investigators opted for a non-inferiority paired design with high-risk chronic gastritis as a primary binary outcome and a non-inferiority margin (Δ) of 5 % (two-sided 95% CI). The non-inferiority margin was established according to clinical judgement, taking into consideration the significance of a missed diagnosis of high-risk preneoplastic condition and previous estimates of the added value offered by the added incisura biopsy. With a power of 80% and a 2-sided α-level set at 0.05, it is estimated that 370 subjects are needed to show non-inferiority. Finally, 400 subjects will be enrolled to compensate for eventual exclusions or protocol deviations.
Cohen's kappa will be used to rate intra and inter-observer concordance for pathologists.
An intermediary analysis for futility is scheduled after 100 patients (25%) are enrolled.
75 studies on the registry are indexed under Gastritis, Atrophic; 37 are open to participants now.
This study's planned enrollment of 400 is below the median of 509 across 54 observational studies indexed under Gastritis, Atrophic.
Browse Gastritis, Atrophic studies →Clinical Hospital Colentina is the lead sponsor of 14 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients over 18 years undergoing upper GI endoscopy are considered eligible for this study, regardless of gender, age or indication.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
this arm has the incisura biopsy scored and added in the OLGA final stage
Other: Incisura biopsy analysis
this arm only has corpus and antrum biopsies scored for OLGA staging
a pathologist blinded to the other biopsies analyzes the biopsy from the incisura
prevalence of OLGA III-IV
number of patients with confirmed OLGA III-IV
Time frame: at time of enrollment
prevalence of OLGIM III-IV
number of patients with confirmed OLGIM III-IV
Time frame: at time of enrollment
Plan to share: Yes — Anonymized data and images from endoscopy and pathology are shared between participating centers according to the protocol.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: The data will be available during the study period, after enrollment of all participants. Possible usage of the anonymized database will be discussed by study investigators.
Access criteria: reasonable request
No publications or documents are linked to this record.
Started Mar 2023 (actual). Primary completion is estimated for Dec 2026, 45 months after the start.
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