Light at the End of the Tunnel: Comparative Effectiveness of Second-Generation Digital SpyGlass With First-Generation SpyGlass® Cholangioscopy Presidential Poster

Abstract

Introduction: Cholangioscopy and pancreatoscopy permit direct visualization of bile and pancreatic ducts. While the 1st generation SpyGlass cholangioscopy system has demonstrated efficacy in the diagnosis and management of pancreaticobiliary diseases. The 2nd generation Spyglass system DS provides higher resolution digital imaging, and design changes, but the efficacy of this new system has not been evaluated. To evaluate diagnostic and therapeutic performance as well as adverse event rates in patients undergoing cholangioscopy with the 1st and 2nd generation SpyGlass systems. Methods: We performed a retrospective analysis of a prospective cohort of patients undergoing ERCP with 1st and 2nd generation SpyGlass cholangioscopy systems between 2013 and 2015 at a tertiary-care academic medical center. Data regarding procedure indication, diagnostic yield, procedure time, therapeutic intervention, radiation dose, and rate of complications was collected. Results: 96 patients underwent ERCP with SpyGlass cholangioscopy during the study period. 1st generation and 2nd generation SpyGlass systems were utilized in 60 and 36 patients respectively. Male patients comprised 53% of the study population and mean age was 64±16 years (range 21-93 years). Indications for cholangioscopy included stone, and stricture. Pathologic findings were identified in the common bile duct (n = 60), pancreatic duct (n = 2) and right/left hepatic ducts (n = 34). Cholangioscopy-guided biopsy (‘Spybite') was performed in 37 patients while therapeutic intervention with electrohydraulic lithotripsy for stone disease was indicated in 19 patients. Mean procedure time for completion of ERCP with cholangioscopy was shorter with 2nd generation compared with 1st generation Spyglass for both diagnostic [58±13 vs. 49±15 min, P= 0.03] and therapeutic indications [66±14 vs. 52±16 min, P= 0.02]. Radiation doses were found to be lower during use of the 2nd generation cholangioscopy system compared to the 1st generation system (447±451 vs. 271±341mGy, P= 0.04). Diagnostic yield was found to be higher at 89% (17/19) with 2nd generation compared to 76% (13/17) in 1st generation Spyglass (P= 0.05). Complications were rare and no differences were found between either group. Conclusion: 2nd generation digital SpyGlass appears to safely provide enhanced diagnostic capabilities, shorter procedure times and less radiation exposure compared to 1st generation cholangioscopy.