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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • No intervention (observational study) — OTHER
    Participants 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 Cohort
    Patients 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

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