Validation of the Odesa Criteria 2026 for Autoimmune Pancreatitis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMilitary Medical Clinical Center of the Southern Region, Ukraine
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults (≥18 years) undergoing evaluation for suspected autoimmune pancreatitis.
Availability of clinical, serological, imaging, and/or histological data required for OC26 scoring.
Ability to provide informed consent (for prospective participants).
Disqualifiers
Confirmed alternative diagnosis explaining pancreatic findings (e.g., pancreatic cancer, acute pancreatitis of other etiology).
Incomplete diagnostic data preventing OC26 scoring.
Prior pancreatic surgery altering diagnostic interpretation.
Trial population
Patients undergoing diagnostic evaluation for suspected autoimmune pancreatitis at a tertiary referral center. The study includes both retrospective cases with complete diagnostic data and prospective participants evaluated according to the Odesa Criteria 2026 (OC26).
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
No intervention (observational study)
Other interventionParticipants receive no assigned intervention. Diagnostic evaluation follows routine clinical practice.
Treatment groups
82 Participants
are divided into 1 treatment groupGroup A: AIP Suspected Cohort1 intervention
Trial outcomes
Primary outcomes
1
Diagnostic accuracy of the Odesa Criteria 2026 (OC26) as a domain-based scoring system for autoimmune pancreatitis
Evaluation of the diagnostic performance of the Odesa Criteria 2026 (OC26), a domain-based point scoring system for autoimmune pancreatitis (AIP). The analysis includes calculation of sensitivity, specificity, positive predictive value, negative predictive value, likelihood ratios, and overall diagnostic accuracy using final clinical diagnosis as the reference standard.
Time frame
At completion of baseline diagnostic assessmentSecondary outcomes
1
Interobserver agreement for OC26 domain scoring
Assessment of interobserver agreement for each domain of the Odesa Criteria 2026 (OC26), including morphology, serology, clinical features, and histology. Agreement will be quantified using Cohen's kappa (κ) statistics for categorical items and intraclass correlation coefficients (ICC) for continuous or ordinal components. The analysis evaluates reproducibility of domain-level scoring among independent reviewers.
Time frame
At completion of baseline diagnostic workup2
Diagnostic performance of individual OC26 domains
Evaluation of the diagnostic performance of each OC26 domain (morphology, serology, clinical, histology) in identifying autoimmune pancreatitis. For each domain, sensitivity, specificity, positive predictive value, negative predictive value, and area under the ROC curve (AUC) will be calculated using final clinical diagnosis as the reference standard.
Time frame
At completion of baseline diagnostic workup3
ROC curve analysis for total OC26 score
Receiver operating characteristic (ROC) curve analysis of the total OC26 score to determine its discriminative ability for diagnosing autoimmune pancreatitis. The area under the curve (AUC) will be calculated, and performance will be compared across predefined subgroups.
Time frame
At completion of baseline diagnostic workup4
Optimal cut-off value for OC26 total score
Determination of the optimal diagnostic cut-off for the OC26 total score using Youden's index and other threshold-optimization methods. Sensitivity, specificity, and accuracy at the optimal cut-off will be reported.
Time frame
At completion of baseline diagnostic workupSponsors and contacts
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Source ClinicalTrials.gov