Assessment of the Role of Incisura Biopsy in the Staging of Chronic Gastritis

Last updated: April 2, 2024
Sponsor: Clinical Hospital Colentina
Overall Status: Active - Recruiting

Phase

N/A

Condition

Non-ulcer Dyspepsia (Nud)

Heartburn

Stomach Discomfort

Treatment

Incisura biopsy analysis

Clinical Study ID

NCT05744596
INCREASE
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • indication to perform upper GI endoscopy for diagnosis or surveillance

Exclusion

Exclusion Criteria:

  • lack of informed consent, previously diagnosed advanced gastric cancer, incompleteendoscopy, surgically altered stomach

Study Design

Total Participants: 400
Treatment Group(s): 1
Primary Treatment: Incisura biopsy analysis
Phase:
Study Start date:
March 23, 2023
Estimated Completion Date:
December 31, 2024

Connect with a study center

  • Colentina Clinical Hospital

    Bucharest, 021025
    Romania

    Active - Recruiting

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