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<p>The Milan System for Reporting Salivary Gland Cytopathology (MSRSGC) was introduced to standardize cytological diagnosis and provide risk of malignancy (ROM) estimates. While validation studies from Western and Asian populations have confirmed its clinical value, data from the Middle East remain scarce. To validate the diagnostic accuracy of the Milan System in a Middle Eastern tertiary care population, calculate ROM values, assess demographic and clinical predictors of malignancy, and analyze recurrence and survival outcomes. We conducted a retrospective diagnostic accuracy study of 144 patients with salivary gland tumors who underwent fine-needle aspiration (FNA) followed by surgical excision (2014–2023). FNA results were classified using the Milan System and compared with final histopathology. Diagnostic performance metrics, including sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and overall accuracy with 95% confidence intervals (CIs), were calculated. Logistic regression was used to evaluate predictors of malignancy. Recurrence-free survival was analyzed with the Kaplan–Meier method. Of 144 patients, 138 had complete cytology and histopathology data. ROM values were 0% for category I, 11.8% for category II, 14.3% for AUS, 5.9% for SUMP, and 87.0% for malignant. Overall sensitivity was 71.4% (95% CI 52.9–84.7), specificity 97.3% (95% CI 92.4–99.1), PPV 87.0%, NPV 93.1%, and diagnostic accuracy 92.1% (95% CI 86.4–95.5). No demographic or clinical predictors were significantly associated with malignancy. Recurrence occurred in 12.9% of malignant versus 3.5% of benign cases. The Milan System demonstrated high diagnostic accuracy and reliable ROM estimates in this Middle Eastern population. Cytological categorization remained the most important predictor of malignancy, while recurrence analysis reinforced its prognostic significance. These findings support wider adoption of the Milan System in the region and highlight the need for prospective, multi-institutional validation.</p>

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Diagnostic Accuracy of the Milan Classification System for Salivary Gland Cytology: A Retrospective Validation in a Middle Eastern Tertiary Center

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  • 发表日期：

    2026年2月16日

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  • Mohammed Al-Essa

摘要

The Milan System for Reporting Salivary Gland Cytopathology (MSRSGC) was introduced to standardize cytological diagnosis and provide risk of malignancy (ROM) estimates. While validation studies from Western and Asian populations have confirmed its clinical value, data from the Middle East remain scarce. To validate the diagnostic accuracy of the Milan System in a Middle Eastern tertiary care population, calculate ROM values, assess demographic and clinical predictors of malignancy, and analyze recurrence and survival outcomes. We conducted a retrospective diagnostic accuracy study of 144 patients with salivary gland tumors who underwent fine-needle aspiration (FNA) followed by surgical excision (2014–2023). FNA results were classified using the Milan System and compared with final histopathology. Diagnostic performance metrics, including sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and overall accuracy with 95% confidence intervals (CIs), were calculated. Logistic regression was used to evaluate predictors of malignancy. Recurrence-free survival was analyzed with the Kaplan–Meier method. Of 144 patients, 138 had complete cytology and histopathology data. ROM values were 0% for category I, 11.8% for category II, 14.3% for AUS, 5.9% for SUMP, and 87.0% for malignant. Overall sensitivity was 71.4% (95% CI 52.9–84.7), specificity 97.3% (95% CI 92.4–99.1), PPV 87.0%, NPV 93.1%, and diagnostic accuracy 92.1% (95% CI 86.4–95.5). No demographic or clinical predictors were significantly associated with malignancy. Recurrence occurred in 12.9% of malignant versus 3.5% of benign cases. The Milan System demonstrated high diagnostic accuracy and reliable ROM estimates in this Middle Eastern population. Cytological categorization remained the most important predictor of malignancy, while recurrence analysis reinforced its prognostic significance. These findings support wider adoption of the Milan System in the region and highlight the need for prospective, multi-institutional validation.