Background: Accurate diagnosis of indeterminate biliary lesions is essential for treatment planning. The currently available techniques have some limitations in evaluating indeterminate biliary lesions. SpyGlass single-operator peroral cholangioscopy system has been developed to overcome these limitations.
Aim: The aim of this retrospective study was to evaluate the diagnostic accuracy of SpyGlass visual assessment and SpyBite biopsy in patients with indeterminate biliary lesions.
Methods: We conducted a retrospective analysis of data from 36 patients with indeterminate biliary strictures or filling defects who had inconclusive results on the cross-sectional imaging study from September 2010 to October 2013. Four patients were excluded because of the presence of a metastatic mass and an ampulla of Vater cancer.
Results: Thirty-two patients (19 men, mean age 63.7 years) with indeterminate biliary lesions underwent SpyGlass cholangioscopy. The cholangioscopy procedure with SpyGlass was technically successful in all of the cases except for one case because of the intraprocedural breakage of the SpyGlass optic probe (96.8%, 31/32). The biopsy specimens from nineteen patients were obtained using SpyBite forceps. The sensitivity, specificity, and overall accuracy of SpyGlass visual assessment and SpyBite biopsy for the diagnosis of malignancy were 100% (21/21) and 64.2% (9/14), 90% (9/10) and 100% (5/5), and 96.7% (30/31) and 73.6% (14/19), respectively. Procedure-related complications were noted in three cases; postsphincterotomy bleeding in one case and mild pancreatitis in two cases.
Conclusions: SpyGlass cholangioscopy with SpyBite biopsy is highly accurate and safe for differentiating malignant lesions from benign lesions in patients with indeterminate biliary lesions.
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