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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic; Gastritis, Atrophic
• Intervention / Treatment: Other: Incisura biopsy analysis

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.

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Andrei Voiosu; Phone Number: +40213173245; Email: andreivoiosu@gmail.com

Study Locations

• Portugal
  • Porto, Portugal
    • Recruiting
    • IPO Porto
    • Contact: Mario Dinis-Ribeiro
• Romania
  • Bucharest
    • Bucharest, Bucharest, Romania, 021025
      • Recruiting
      • Colentina Clinical Hospital
      • Contact: Andrei Voiosu, PhD; Phone Number: +4 021 3173245
      • Principal Investigator: Andrei Voiosu, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

All patients over 18 years undergoing upper GI endoscopy are considered eligible for this study, regardless of gender, age or indication.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Incisura biopsy +; this arm has the incisura biopsy scored and added in the OLGA final stage	Other: Incisura biopsy analysis; a pathologist blinded to the other biopsies analyzes the biopsy from the incisura
Incisura biopsy -; this arm only has corpus and antrum biopsies scored for OLGA staging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
prevalence of OLGA III-IV	number of patients with confirmed OLGA III-IV	at time of enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
prevalence of OLGIM III-IV	number of patients with confirmed OLGIM III-IV	at time of enrollment

Collaborators and Investigators

• Sponsor: Clinical Hospital Colentina
• Collaborators: Instituto Portugues de Oncologia, Francisco Gentil, Porto

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: February 7, 2023
• First Submitted That Met QC Criteria: February 15, 2023
• First Posted (Actual): February 27, 2023

Study Record Updates

• Last Update Posted (Actual): March 9, 2026
• Last Update Submitted That Met QC Criteria: March 5, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Gastroenteritis; Gastritis; Gastritis, Atrophic
• Other Study ID Numbers: INCREASE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized data and images from endoscopy and pathology are shared between participating centers according to the protocol.
• IPD Sharing Time Frame: The data will be available during the study period, after enrollment of all participants. Possible usage of the anonymized database will be discussed by study investigators.
• IPD Sharing Access Criteria: reasonable request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No