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

BACKGROUND: Current 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.

OBJECTIVE: To 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.

DESIGN: Laboratory 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.

SETTING: Research laboratories.

MAIN OUTCOME MEASUREMENTS: Rate ratios (RR) and 95% confidence intervals (CI) for successful access to all quadrants and simulated biopsy.

RESULTS: Success 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.

LIMITATIONS: Study procedures were performed by a single nonblinded operator. All data were collected ex vivo or in animals, and clinical applicability remains to be determined.

CONCLUSIONS: The Spyglass system allows access and biopsy in all quadrants and merits clinical investigation.