Validation of the Odesa Criteria 2026 for Autoimmune Pancreatitis

NCT07536841 | Recruiting

• 1 other identifier: OC26-AIP
• Study Type: observational
• Target: 82
• Locations: 1 country
• Sites: 2

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.

Conditions

Autoimmune Pancreatitis; IgG4-Related Diseases; Pancreatic Cancer; Chronic Pancreatitis

Keywords

AIP; IgG4; Autoimmune pancreatitis diagnosis; Pancreatic imaging; Endoscopic ultrasound; Serum protein fractions; IgG6/IgG8 ratio; Odesa Criteria 2026 (OC26); EUS Doppler

Outcome Measures

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.

  At completion of baseline diagnostic assessment

Secondary Outcomes (4)

• Interobserver agreement for OC26 domain scoring

  At completion of baseline diagnostic workup

• Diagnostic performance of individual OC26 domains

  At completion of baseline diagnostic workup

• ROC curve analysis for total OC26 score

  At completion of baseline diagnostic workup

• Optimal cut-off value for OC26 total score

  At completion of baseline diagnostic workup

Study Arms (1)

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)

Interventions

No intervention (observational study) OTHER

Participants receive no assigned intervention. Diagnostic evaluation follows routine clinical practice.

AIP Suspected Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Military Medical Clinical Center of the Southern Region, Ukraine: lead

Study Sites (2)

Military Medical Clinical Center of the Southern Region

Odesa, Ukraine

RECRUITING

Military Medical Clinical Center of the Southern Region

Odesa, Ukraine

RECRUITING

Related Publications (2)

• Hohenstein B, Colin M, Foellmer C, Amann KU, Brekken RA, Daniel C, Hugo CP. Autocrine VEGF-VEGF-R loop on podocytes during glomerulonephritis in humans. Nephrol Dial Transplant. 2010 Oct;25(10):3170-80. doi: 10.1093/ndt/gfq200. Epub 2010 Apr 15.

  PMID: 20395257 BACKGROUND

• Jones CJ, Larive CK. Could smaller really be better? Current and future trends in high-resolution microcoil NMR spectroscopy. Anal Bioanal Chem. 2012 Jan;402(1):61-8. doi: 10.1007/s00216-011-5330-7. Epub 2011 Aug 31.

  PMID: 21879299 BACKGROUND

MeSH Terms

Conditions

Autoimmune Pancreatitis; Immunoglobulin G4-Related Disease; Pancreatic Neoplasms; Pancreatitis, Chronic

Interventions

Observation

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Oleg Dovbenko

  Odesa Regional Clinical Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oleg Dovbenko, MD, PhD

CONTACT

+380682539685; dovbenko2015@hotmail.com

Oleg Dovbenko, MD, PhD

CONTACT

+380682539685; dovbenko73@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Endoscopic Surgery Department

Study Record Dates

• First Submitted: April 11, 2026
• First Posted: April 17, 2026
• Study Start: May 1, 2026
• Primary Completion: May 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

UA (2)