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CLINICAL TRIAL
JOURNAL ARTICLE
Prospective evaluation of the clinical utility of ERCP-guided cholangiopancreatoscopy with a new direct visualization system.
Gastrointestinal Endoscopy 2011 May
BACKGROUND: Older systems for cholangiopancreatoscopy have demonstrated improved diagnostic and therapeutic abilities over standard ERCP but have shown limited feasibility. The SpyGlass 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 SpyGlass system.
DESIGN: Prospective cohort study.
SETTING: Tertiary care center.
PATIENTS: All patients undergoing cholangiopancreatoscopy at our institution.
INTERVENTIONS: Cholangiopancreatoscopy with the SpyGlass 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 SpyScope to the desired target, (2) adequate visualization, and (3) successful applications of all necessary diagnostic and/or therapeutic maneuvers.
RESULTS: Overall, SpyGlass 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 ERCP plus SpyGlass) was 64.3 minutes, the total SpyGlass time was 27.5 minutes, the mean SpyGlass visualization time was 14.2 minutes, the mean SpyBite 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 SpyGlass system is technically feasible and can be successfully and safely performed in the vast majority of patients. (
CLINICAL TRIAL REGISTRATION NUMBER: NCT00861198.).
OBJECTIVE: To prospectively evaluate the feasibility, clinical efficacy, and safety of the SpyGlass system.
DESIGN: Prospective cohort study.
SETTING: Tertiary care center.
PATIENTS: All patients undergoing cholangiopancreatoscopy at our institution.
INTERVENTIONS: Cholangiopancreatoscopy with the SpyGlass 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 SpyScope to the desired target, (2) adequate visualization, and (3) successful applications of all necessary diagnostic and/or therapeutic maneuvers.
RESULTS: Overall, SpyGlass 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 ERCP plus SpyGlass) was 64.3 minutes, the total SpyGlass time was 27.5 minutes, the mean SpyGlass visualization time was 14.2 minutes, the mean SpyBite 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 SpyGlass system is technically feasible and can be successfully and safely performed in the vast majority of patients. (
CLINICAL TRIAL REGISTRATION NUMBER: NCT00861198.).
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