NCT05744596

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 400 (estimated)
• Sponsor: Clinical Hospital Colentina · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• Chronic; Gastritis, Atrophic

Interventions

Type	Name	Description
OTHER	Incisura biopsy analysis	a pathologist blinded to the other biopsies analyzes the biopsy from the incisura

Timeline

• Start date: 2023-03-23
• Primary completion: 2026-12-01
• Completion: 2027-03-01
• First posted: 2023-02-27
• Last updated: 2026-03-09

Locations

2 sites across 2 countries: Portugal, Romania