Ambispective Validation of the Odesa Criteria 2026 (OC26): A Flexible Point-Based System for Diagnosis of Autoimmune Pancreatitis.

NCT07536841 | Not Yet Recruiting

• 1 other identifier: OC26-AIP
• Study Type: observational
• Target: 82
• Locations: 0 countries
• Sites: N/A

Brief Summary

Approval Number protocol 020237 Board Name Ethics Committee of the Military Medical Clinical Center of the Southern Region. Board Affiliation Military Medical Clinical Center of the Southern Region, Ukraine. Board Contact Information Phone: +380 (50) 316-10-54)

Conditions

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

Keywords

AIP; IgG4; Odesa Criteria 2026(ОС26); Autoimmune pancreatitis diagnosis; Pancreatic imaging; Endoscopic ultrasound; ЕUS Doppler; Serum protein fractions; IgG6/IgG8 ratio

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of the Odesa Criteria 2026 (OC26) for autoimmune pancreatitis

  Assessment of the diagnostic performance of the Odesa Criteria 2026 (OC26) in identifying autoimmune pancreatitis (AIP). The analysis includes calculation of sensitivity, specificity, positive predictive value, negative predictive value, and overall diagnostic accuracy using final clinical diagnosis as the reference standard.

  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.

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

MeSH Terms

Conditions

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

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

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 (Estimated): October 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share