S0905 Prospective Multicenter International Trial Evaluating Performance of Disposable Elevator Cap Duodenoscope During Endoscopic Retrograde Cholangiopancreatography (deCAP Trial)

Abstract

INTRODUCTION: Persistent contamination of elevator mechanism despite reprocessing has resulted in outbreaks of infection with multidrug-resistant organisms following Endoscopic Retrograde Cholangiopancreatography (ERCP). Novel duodenoscope with disposable elevator cap (DEC) might reduce these infections. We tested performance of DEC-duodenoscope in patients undergoing ERCP. METHODS: We conducted a prospective case-series study of outcomes of ERCP using DEC duodenoscope at two academic medical centers. Six endoscopists (experience 1 to 10+ years) and nurse/technicians participated in the study. Outcomes analyzed included evaluation of pre-procedure set up, post procedure reprocessing by nurse/technicians. ERCP outcomes included successful completion of ERCP, endoscopist rating on ERCP performance characteristics as well as ERCP maneuvers, and adverse events. RESULTS: This is an interim analysis of 108 consecutive ERCPs (Female 66%, 71/108) performed during the study period of May and June 2020. Most common indication was choledocholithiasis (60%, 65/108) and a majority of patients had native papilla (65%, 70/108). 32% of procedures were performed by fellows, while 68% of procedures were performed by attending physicians. Majority of ERCPs were of ASGE ERCP complexity Grade 2 (73%, 79/108). The mean cannulation time was 5.85 mins (SD: ± 7.97 mins) while the mean time to complete the procedure was 26 mins (SD: ± 17.66 mins). All ERCPs were performed under propofol guided deep sedation or general endotracheal anesthesia. All ERCPs were successfully completed without need to change scope . In one case, given inability to pass the instrument via the elevator channel, ERCP scope was removed, same cap was reattached, and then procedure could be successfully completed. Overall performance rating for DEC duodenoscope was 99%-100% in 17 ERCP performance characteristics and 100% in 10 ERCP maneuvers (Table 1). When evaluated by nurse or technician, overall performance rating of DEC duodenoscope was 97%-99% in various pre-procedure, intraprocedural and post-procedure tasks (Table 2). CONCLUSION: We conclude that most endoscopists with varying level of experience, could easily complete various complex ERCP tasks with DEC duodenoscope. This innovative design has the potential to reduce ERCP related infectious outbreak.Table 1.: Rating on ERCP Performance Characteristics and ERCP ManeuversTable 2.: Rating by nurse of technician for pre-procedure set up, intraprocedural performance and post-procedure reprocessing steps