Autoimmune Pancreatitis, Chronic Pancreatitis, IgG4-Related Diseases, Pancreatic Cancer
Conditions
Keywords
AIP, IgG4, Autoimmune pancreatitis diagnosis, Pancreatic imaging, Endoscopic ultrasound, Serum protein fractions, IgG6/IgG8 ratio, Odesa Criteria 2026 (OC26), EUS Doppler
Brief summary
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.
Detailed description
The study uses an ambispective design, including both retrospective and prospective data collection. Autoimmune pancreatitis (AIP) remains a diagnostic challenge due to its heterogeneous clinical presentation and overlap with pancreatic cancer and other inflammatory conditions. The Odesa Criteria 2026 (OC26) were developed as a flexible, domain-based point scoring system integrating four diagnostic domains: morphology, serology, clinical features, and histology. Each domain contributes weighted points toward a total diagnostic score, enabling structured and reproducible assessment across diverse patient phenotypes. This ambispective observational study evaluates the diagnostic performance of OC26 in real-world clinical practice. The study assesses sensitivity, specificity, predictive values, likelihood ratios, and overall diagnostic accuracy using final clinical diagnosis as the reference standard. Additional analyses include interobserver agreement for domain scoring, diagnostic performance of individual domains, ROC curve analysis for the total OC26 score, and determination of the optimal diagnostic cut-off. The study aims to validate OC26 as a practical, scalable, and reproducible diagnostic tool for autoimmune pancreatitis, supporting its implementation in routine clinical workflows and future international guideline development.
Interventions
OTHERNo intervention (observational study)
Participants receive no assigned intervention. Diagnostic evaluation follows routine clinical practice.
Sponsors
Military Medical Clinical Center of the Southern Region, Ukraine
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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).
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic accuracy of the Odesa Criteria 2026 (OC26) as a domain-based scoring system for autoimmune pancreatitis | At completion of baseline diagnostic assessment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Interobserver agreement for OC26 domain scoring | At completion of baseline diagnostic workup | 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. |
| Diagnostic performance of individual OC26 domains | At completion of baseline diagnostic workup | 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. |
| ROC curve analysis for total OC26 score | At completion of baseline diagnostic workup | 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. |
| Optimal cut-off value for OC26 total score | At completion of baseline diagnostic workup | 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. |
Countries
Ukraine
Contacts
CONTACTOleg Dovbenko, MD, PhD
PRINCIPAL_INVESTIGATOROleg Dovbenko
Odesa Regional Clinical Medical Center
Outcome results
None listed