RecruitingNCT05744596

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

Assessment of the Role of INCisura Biopsy in incrEASing the Stage of Chronic Gastritis


Sponsor

Clinical Hospital Colentina

Enrollment

400 participants

Start Date

Mar 23, 2023

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria1

  • indication to perform upper GI endoscopy for diagnosis or surveillance

Exclusion Criteria1

  • lack of informed consent, previously diagnosed advanced gastric cancer, incomplete endoscopy, surgically altered stomach

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Interventions

OTHERIncisura biopsy analysis

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


Locations(2)

IPO Porto

Porto, Portugal

Colentina Clinical Hospital

Bucharest, Bucharest, Romania

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NCT05744596