Role of single-operator peroral cholangioscopy in the diagnosis of indeterminate biliary lesions: a single-center, prospective study

BackgroundCurrently available techniques to diagnose indeterminate biliary lesions have many limitations.ObjectiveTo assess the accuracy of single-operator peroral cholangioscopy by using the SpyGlass system to differentiate malignant from benign disease in patients with indeterminate biliary lesions.DesignProspective, single-arm, single-center study.SettingTertiary referral center.PatientsThirty-six patients with indeterminate biliary strictures and filling defects who had inconclusive results on previous biliary ductal tissue sampling.InterventionsSpyGlass cholangioscopy with cholangioscopically guided intraductal biopsies.Main Outcome MeasurementsAccuracy of SpyGlass visual impression and SpyBite biopsies for differentiating malignant from benign ductal lesions.ResultsThirty-six patients (22 men, mean age 48.3 years [range 27-68 years]) with indeterminate stricture and/or filling defects underwent SpyGlass cholangioscopy. Of the 22 patients with a final diagnosis of malignant lesion, cholangioscopic impression was malignant in 21 patients (95%) and benign in 1 patient (5%). Of the 14 patients with a final diagnosis of benign disease, including the 3 patients with common bile duct stones and no stricture, cholangioscopic impression was malignant in 3 patients (21%) and benign in 11 patients (79%). The overall accuracy of SpyGlass visual impression for differentiating malignant from benign ductal lesions was 89% (32/36). The accuracy of SpyBite biopsies for differentiating malignant from benign ductal lesions that were inconclusive on ERCP-guided brushing or biopsy was 82% (27/33) in an intent-to-treat analysis.LimitationsNo randomized comparison with alternative diagnostic modalities for the nature of biliary strictures.ConclusionsSpyGlass cholangioscopy with SpyBite biopsies has a high accuracy with regard to confirming or excluding malignancy in patients with indeterminate biliary lesions.