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

Background: Currently available techniques to diagnose indeterminate biliary lesions have many limitations.

Objective: To 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.

Design: Prospective, single-arm, single-center study.

Setting: Tertiary referral center.

Patients: Thirty-six patients with indeterminate biliary strictures and filling defects who had inconclusive results on previous biliary ductal tissue sampling.

Interventions: SpyGlass cholangioscopy with cholangioscopically guided intraductal biopsies.

Main Outcome Measurements: Accuracy of SpyGlass visual impression and SpyBite biopsies for differentiating malignant from benign ductal lesions.

Results: Thirty-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.

Limitations: No randomized comparison with alternative diagnostic modalities for the nature of biliary strictures.

Conclusions: SpyGlass cholangioscopy with SpyBite biopsies has a high accuracy with regard to confirming or excluding malignancy in patients with indeterminate biliary lesions.