Clinical evaluation of a single-use duodenoscope for endoscopic retrograde cholangiopancreatography

ABSTRACT BACKGROUND & AIMS Single-use duodenoscopy is one strategy to decrease infectious outbreaks associated with endoscope reuse. The aim of this study was to test the feasibility, preliminary safety and performance of a new single-use duodenoscope in a clinical setting. METHODS We conducted a multicenter case series of ERCP using a single-use duodenoscope from April to May 2019. Patients aged 18 years and older without altered pancreaticobiliary anatomy were consecutively screened at 6 academic medical centers, and eligible patients were enrolled. Seven expert endoscopists performed 13 roll-in maneuvers (duodenoscope navigation and visualization of duodenal papilla only), then 60 ERCPs in separate patients. Outcomes were ERCP completion for the intended clinical indication, crossover from single-use duodenoscope to a reusable duodenoscope, endoscopist performance ratings of the device, and serious adverse events assessed at 72 hours and 7 days. RESULTS Thirteen (100%) roll-in maneuvers were completed using the single-use duodenoscope. ERCPs had American Society for Gastrointestinal Endoscopy procedural complexity Grade 1 (least complex)–7 (11·7%), Grade 2–26 (43·3%), Grade 3–26 (43·3%) and Grade 4 (most complex)–1 (1·7%). Fifty-eight (96.7%) ERCPs were completed using the single-use duodenoscope only and 2 (3.3%) using the single-use duodenoscope followed by crossover to a reusable duodenoscope. Median overall satisfaction was 9 out of 10. Three patients experienced post-ERCP pancreatitis, 1 had a post-sphincterotomy bleed, and 1 with preexisting infection worsened and required rehospitalization. CONCLUSIONS Expert endoscopists completed ERCPs with a wide range of complexity using a single-use duodenoscope in nearly all cases. This represents a new alternative to decrease ERCP-related infection transmission risk. Clinicaltrials.gov no: NCT03701958.