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.