Prospective evaluation of the clinical utility of ERCP-guided cholangiopancreatoscopy with a new direct visualization system

Background: Older systems for cholangiopancreatoscopy have demonstrated improved diagnostic and therapeutic abilities over standard FRCP but have shown limited feasibility. The Spy Glass Direct Visualization System addresses many of the shortcomings of the older platforms, but its potential advantages have not been rigorously evaluated. Objective: To prospectively evaluate the feasibility, clinical efficacy, and safety of the Spy Glass system. Design: Prospective cohort study. Setting: Tertiary care center. Patients: All patients undergoing cholangiopancreatoscopy at our institution. Interventions: Cholangiopancreatoscopy with the Spy Glass system. Main Outcome Measurements: Procedure success, defined as complete stone clearance for stone cases. For nonstone-related lesions, success was defined when all 3 of the following were met: (1) advancement of the Spy Scope to the desired target, (2) adequate visualization, and (3) successful applications of all necessary diagnostic and/or therapeutic maneuvers. Results: Overall, Spy Glass was successful in 70 of 75 patients (93.3%). In patients with biliary stones, complete stone clearance was achieved in 24 of 26 patients (92.3%). Cholangioscopy for nonstone-related indications was successful in 43 of 44 patients (97.7%). Pancreatoscopy was attempted in 5 patients and was successful in 3(60%). The mean total procedure time (standard FRCP plus Spy Glass) was 64.3 minutes, the total Spy Glass time was 27.5 minutes, the mean Spy Glass visualization time was 14.2 minutes, the mean Spy Bite sampling time was 12.1 minutes, the mean Spy therapy time was 8.4 minutes, and the mean set-up time was 5 minutes. There were 4 adverse events (4.8%). Limitations: Single-center experience, no comparison group, potential for selection bias. Conclusions: ERCP-guided cholangiopancreatoscopy with the Spy Glass system is technically feasible and can be successfully and safely performed in the vast majority of patients. (Clinical trial registration number: NCT00861198.) (Gastrointest Enclose 2011;73:971-9.)