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Clinical Trials in Portugal / NCT05744596
Recruiting Observational

Assessment of the Role of Incisura Biopsy in the Staging of Chronic Gastritis

NCT05744596 · tracked via the Priya Life Science Portugal tracker
Sponsor
Clinical Hospital Colentina
Phase
Observational
Started
2023-03-23
Last updated
2026-03-09

Condition(s) studied

Chronic; Gastritis, Atrophic

Investigational drug(s) / intervention(s)

Incisura biopsy analysis

Incisura biopsy analysis: a pathologist blinded to the other biopsies analyzes the biopsy from the incisura

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: * indication to perform upper GI endoscopy for diagnosis or surveillance Exclusion Criteria: * lack of informed consent, previously diagnosed advanced gastric cancer, incomplete endoscopy, surgically altered stomach

Primary outcome measure(s)

  • prevalence of OLGA III-IV — at time of enrollment
    number of patients with confirmed OLGA III-IV

Trial sites (2)

FacilityCityRegionStatus
IPO Porto Porto Portugal Recruiting
Colentina Clinical Hospital Bucharest Bucharest Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05744596 on ClinicalTrials.gov ↗ ← All trials in Portugal