Assessment of the Role of Incisura Biopsy in the Staging of Chronic Gastritis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Incisura biopsy analysis.
- Who it may be relevant to
- Registry conditions: Chronic; Gastritis, Atrophic. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Portugal, Romania
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Assessment of the Role of INCisura Biopsy in incrEASing the Stage of Chronic Gastritis
Overview
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.
Interventions
- Other Incisura biopsy analysis
a pathologist blinded to the other biopsies analyzes the biopsy from the incisura
Primary outcome measures
- prevalence of OLGA III-IV [Time frame: at time of enrollment]
Secondary outcome measures (1)
- prevalence of OLGIM III-IV [Time frame: at time of enrollment]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Portugal · 1 center
- IPO Porto — Porto
Romania · 1 center
- Colentina Clinical Hospital — Bucharest
Identifiers
NCT: NCT05744596 · INCREASE