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.
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.
Authors: R J S Coelen; M J de Keijzer; R Weijer; V V Loukachov; J K Wiggers; F P J Mul; A C W A van Wijk; Y Fong; M Heger; T M van Gulik Journal: Cancer Gene Ther Date: 2017-04-14 Impact factor: 5.987
Authors: Wim Laleman; Kristof Verraes; Werner Van Steenbergen; David Cassiman; Frederik Nevens; Schalk Van der Merwe; Chris Verslype Journal: Surg Endosc Date: 2016-09-07 Impact factor: 4.584