Validation of the Odesa Criteria 2026 for Autoimmune Pancreatitis (ОС26)

May 23, 2026 updated by: Oleg Dovbenko, MD, Military Medical Clinical Center of the Southern Region, Ukraine

Validation of the Odesa Criteria 2026 (OC26) for the Diagnosis of Autoimmune Pancreatitis

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

82

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Ukraine
      • Odesa, Ukraine
        • Recruiting
        • Military Medical Clinical Center of the Southern Region
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study 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).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: No intervention (observational study)
Participants receive no assigned intervention. Diagnostic evaluation follows routine clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
At completion of baseline diagnostic assessment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interobserver agreement for OC26 domain scoring
Time Frame: 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.
At completion of baseline diagnostic workup
Diagnostic performance of individual OC26 domains
Time Frame: 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.
At completion of baseline diagnostic workup
ROC curve analysis for total OC26 score
Time Frame: 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.
At completion of baseline diagnostic workup
Optimal cut-off value for OC26 total score
Time Frame: 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.
At completion of baseline diagnostic workup

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Military Medical Clinical Center of the Southern Region, Ukraine

Investigators

  • Principal Investigator: Oleg Dovbenko, Odesa Regional Clinical Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2026

Primary Completion (Actual)

May 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

April 11, 2026

First Submitted That Met QC Criteria

April 11, 2026

First Posted (Actual)

April 17, 2026

Study Record Updates

Last Update Posted (Actual)

May 28, 2026

Last Update Submitted That Met QC Criteria

May 23, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OC26-AIP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared because the study involves sensitive clinical information and the dataset is not intended for external distribution. Only aggregated, de-identified results will be available in publications.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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