Evaluating the benefit of incisura biopsy for chronic gastritis staging
Assessment of the Role of INCisura Biopsy in incrEASing the Stage of Chronic Gastritis
This study is testing if adding a specific type of biopsy can help doctors better diagnose and stage high-risk chronic gastritis in patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Clinical Hospital Colentina Academic / other |
| Locations | 2 sites (Porto and 1 other locations) |
| Trial ID | NCT05744596 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the effectiveness of incorporating an incisura biopsy in the staging of patients with high-risk chronic gastritis, specifically those at OLGA stages III-IV. It is a prospective multicenter study that compares the outcomes of a biopsy protocol that includes an incisura biopsy against one that does not, using a non-inferiority design. The goal is to determine if the additional biopsy improves the accuracy of diagnosis and staging in these patients.
Who should consider this trial
Good fit: Ideal candidates are individuals scheduled for upper GI endoscopy due to indications for diagnosis or surveillance of chronic gastritis.
Not a fit: Patients who have previously been diagnosed with advanced gastric cancer or those with surgically altered stomachs may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the diagnostic accuracy and treatment planning for patients with high-risk chronic gastritis.
How similar studies have performed: While this approach is being evaluated in this study, similar methodologies have shown promise in enhancing diagnostic accuracy in other gastrointestinal conditions.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Porto and 1 other locations
- IPO Porto — Porto, Portugal (Recruiting)
- Colentina Clinical Hospital — Bucharest, Bucharest, Romania (Recruiting)
Study contacts
- Study coordinator: Andrei Voiosu
- Email: andreivoiosu@gmail.com
- Phone: +40213173245
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.