Preclinical characterization of the Spyglass peroral cholangiopancreatoscopy system for direct access, visualization, and biopsy

BackgroundCurrent cholangioscopes are restricted to 2 deflection angles and require more than 1 operator. The newly developed Spyglass peroral cholangiopancreatoscopy system provides 4-way deflected steering by a single operator.ObjectiveTo evaluate access and biopsy in all simulated biliary-duct quadrants with the Spyglass system, high-level disinfection of the reusable Spyglass optical probe, and feasibility of in vivo biopsy.DesignLaboratory simulations comparing biliary-duct access and biopsy with the Spyglass versus a conventional system, laboratory determination of high-level disinfection effectiveness, and observational investigation of biopsies in a porcine model.SettingResearch laboratories.Main Outcome MeasurementsRate ratios (RR) and 95% confidence intervals (CI) for successful access to all quadrants and simulated biopsy.ResultsSuccess rates for access in all quadrants were significantly higher with the Spyglass system than with the control system, both without (RR 1.71, 95% CI 1.39-2.29) and with (RR 2.00, 95% CI 1.56-2.78) biopsy forceps loaded. Higher success rates were also attained by using the Spyglass system to access biopsy targets (RR 2.09, 95% CI 1.60-2.91) and to perform simulated biopsies (RR 2.94, 95% CI 2.05-4.52). Microbial species log reductions of 6.0 to 7.0 were achieved by high-level disinfection of Spyglass optical probes. In 31 in vivo porcine biopsies yielding adequate gross specimens, the quality for histologic examination was excellent to adequate for 90% of specimens.LimitationsStudy procedures were performed by a single nonblinded operator. All data were collected ex vivo or in animals, and clinical applicability remains to be determined.ConclusionsThe Spyglass system allows access and biopsy in all quadrants and merits clinical investigation.