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Reliability and accuracy of a novel classification system using peroral cholangioscopy for the diagnosis of bile duct lesions

Abstract:

Background The aim of this study was to propose a novel, comprehensive, macroscopic classification for bile duct lesions. Methods A two-stage protocol was designed. In Stage I, a retrospective study (September 2013 to September 2015) of patients with bile duct lesions detected by peroral cholangioscopy (POCS) was performed. A total of 315 images with at least 6 months of follow-up were recorded, analyzed, and correlated to histology, and were classified as non-neoplastic (one of three types, 1-3) or neoplastic (one of four types, 1-4) based on morphological and vascular patterns. In Stage II, a prospective, nonrandomized, double-blind study was performed from December 2015 to December 2016 to validate the proposed classification. Sensitivity, specificity, positive and negative pbkp_redictive values (PPV and NPV, respectively), and positive and negative likelihood ratios (LR+and LR-, respectively) were calculated (gold standard: 6-month follow-up). Inter- and intraobserver agreement (kappa value, κ) among experts and non-experts were calculated. Results 171 patients were included (65 retrospective; 106 prospective). In Stage I, 28/65 cases were neoplastic and 37/65 were non-neoplastic, according to the final diagnosis. In Stage II, 56/106 were neoplastic with a sensitivity, specificity, PPV, NPV, LR+, and LR-for neoplastic diagnosis of 96.3%, 92.3%, 92.9%, 96%, 12.52, and 0.04, respectively. The proposed classification presented high reproducibility among observers, for both neoplastic and subtypes categories. However, it was better for experts (κ>80%) than non-experts (κ 64.7%-81.9%). Conclusion The novel classification system could help physicians to distinguish non-neoplastic from neoplastic bile duct lesions.