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

NCT05744596 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2026-03-09

No results posted yet for this 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.

Conditions

  • Chronic; Gastritis, Atrophic

Interventions

OTHER

Incisura biopsy analysis

a pathologist blinded to the other biopsies analyzes the biopsy from the incisura

Sponsors & Collaborators

  • Instituto Portugues de Oncologia, Francisco Gentil, Porto

    collaborator OTHER
  • Clinical Hospital Colentina

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-23
Primary Completion
2026-12-31
Completion
2027-03-31

Countries

  • Portugal
  • Romania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05744596 on ClinicalTrials.gov