title: Prospective evaluation of the clinical utility of ERCP-guided cholangiopancreatoscopy with a new direct visualization system.
abstract: 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.
  
  
  METHODS
  Prospective cohort study.
  
  
  METHODS
  Tertiary care center.
  
  
  METHODS
  All patients undergoing cholangiopancreatoscopy at our institution.
  
  
  METHODS
  Cholangiopancreatoscopy with the SpyGlass system.
  
  
  METHODS
  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%).
  
  
  CONCLUSIONS
  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. (
  
  
  BACKGROUND
  NCT00861198.).
authors.affiliation: Department of Medicine, University of Florida College of Medicine, Gainesville, Florida 32610, USA.
authors.forename: Peter V
authors.initials: PV
authors.lastname: Draganov
authors.forename: Tong
authors.initials: T
authors.lastname: Lin
authors.forename: Shailendra
authors.initials: S
authors.lastname: Chauhan
authors.forename: Mihir S
authors.initials: MS
authors.lastname: Wagh
authors.forename: Wei
authors.initials: W
authors.lastname: Hou
authors.forename: Chris E
authors.initials: CE
authors.lastname: Forsmark
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001649:Bile Duct Diseases / Q000175:diagnosis*; D002760:Cholangiopancreatography, Endoscopic Retrograde / Q000295:instrumentation / Q000706:statistics & numerical data*; D019723:Endoscopes; D004867:Equipment Design; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D015203:Reproducibility of Results; D055815:Young Adult