Validation of the Odesa Criteria 2026 (OC26) for the Diagnosis of Autoimmune Pancreatitis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy of the Odesa Criteria 2026 (OC26) for autoimmune pancreatitis
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: No intervention (observational study) (Other)
结局指标
主要结局
Diagnostic accuracy of the Odesa Criteria 2026 (OC26) for autoimmune pancreatitis
时间窗: At completion of baseline diagnostic workup
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.
Diagnostic accuracy of the Odesa Criteria 2026 (OC26) as a domain-based scoring system for autoimmune pancreatitis
时间窗: 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.
次要结局
- 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)
研究者
Oleg Dovbenko, MD
Head of Endoscopic Surgery Department
Military Medical Clinical Center of the Southern Region, Ukraine