Assessment of the Role of Incisura Biopsy in the Staging of Chronic Gastritis
ConditionChronic; Gastritis, Atrophic
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorClinical Hospital Colentina
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
indication to perform upper GI endoscopy for diagnosis or surveillance
Disqualifiers
lack of informed consent, previously diagnosed advanced gastric cancer, incomplete endoscopy, surgically altered stomach
Trial population
All patients over 18 years undergoing upper GI endoscopy are considered eligible for this study, regardless of gender, age or indication.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Incisura biopsy analysis
Other interventiona pathologist blinded to the other biopsies analyzes the biopsy from the incisura
Treatment groups
400 Participants
are divided into 2 treatment groupsGroup A: Incisura biopsy +1 intervention
Group B: Incisura biopsy -0 interventions
Trial outcomes
Primary outcomes
1
prevalence of OLGA III-IV
number of patients with confirmed OLGA III-IV
Time frame
at time of enrollmentSecondary outcomes
1
prevalence of OLGIM III-IV
number of patients with confirmed OLGIM III-IV
Time frame
at time of enrollmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Clinical Hospital Colentina
Lead sponsor
Instituto Portugues de Oncologia, Francisco Gentil, Porto
Collaborator
Source ClinicalTrials.gov