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

Recruiting

• Conditions: Chronic; Gastritis, Atrophic
• Interventions: Other: Incisura biopsy analysis

• Registration Number: NCT05744596
• Lead Sponsor: Clinical Hospital Colentina

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-07
• Study First Submitted QC: 2023-02-15
• Study First Posted: 2023-02-27
• Study Start: 2023-03-23
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-02
• Last Update Posted: 2024-04-03
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Incisura biopsy +	Incisura biopsy analysis	this arm has the incisura biopsy scored and added in the OLGA final stage

Primary Outcome Measures

Name	Time	Method
prevalence of OLGA III-IV	at time of enrollment

Secondary Outcome Measures

Name	Time	Method
prevalence of OLGIM III-IV	at time of enrollment

Trial Locations

Locations (1)

Colentina Clinical Hospital; 🇷🇴 Bucharest, Romania