Validation of the Odesa Criteria 2026 for Autoimmune Pancreatitis
- Sponsor
- Military Medical Clinical Center of the Southern Region, Ukraine
- Study ID
- NCT07536841
- Status
- Recruiting
Conditions
- Autoimmune Pancreatitis
- Chronic Pancreatitis
- IgG4-Related Diseases
- Pancreatic Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- No intervention (observational study) — OTHERParticipants receive no assigned intervention. Diagnostic evaluation follows routine clinical practice.
Study Details
This ambispective observational study aims to validate the Odesa Criteria 2026 (OC26), a flexible domain-based point scoring system for diagnosing autoimmune pancreatitis. The study evaluates diagnostic accuracy and reproducibility of OC26 across clinical, serological, morphological, and histological domains.
Key Dates
- Start date
- May 1, 2026
- Status verified
- Apr 2026
- Primary completion
- May 1, 2026
- Completion
- Dec 1, 2026
Study Design
- Enrollment
- 82 participants (estimated)
Arms
- Arm: AIP Suspected CohortPatients evaluated for suspected autoimmune pancreatitis. Participants undergo standard clinical, serological, imaging, and histological assessment according to the Odesa Criteria 2026 (OC26). No interventions are assigned as this is an observational study.
Primary Outcome Measure
Diagnostic accuracy of the Odesa Criteria 2026 (OC26) as a domain-based scoring system for autoimmune pancreatitis [ Time Frame: At completion of baseline diagnostic assessment ]
Central Contacts
- Oleg Dovbenko, MD, PhD+380682539685
- Oleg Dovbenko, MD, PhD+380682539685
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