Assessment of the Role of Incisura Biopsy in the Staging of Chronic Gastritis (INCREASE)

Clinical Hospital Colentina

Status: Enrolling

Conditions: Chronic; Gastritis, Atrophic

Treatments: Other: Incisura biopsy analysis

Study type: Observational

Funder types: Other

Identifiers

NCT05744596

INCREASE

Details and patient eligibility

About

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.

Full description

We will perform a prospective, multicenter, randomized controlled trial of 2 different gastric biopsy protocols. Our 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, we 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, we estimate that 370 subjects are needed to show non-inferiority. Finally, we will enroll 400 subjects 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

400 participants in 2 patient groups

Incisura biopsy +

Description:

this arm has the incisura biopsy scored and added in the OLGA final stage

Treatment:

Other: Incisura biopsy analysis

Incisura biopsy -

Description:

this arm only has corpus and antrum biopsies scored for OLGA staging