Clinical Evaluation of a Single-Use Duodenoscope for Endoscopic Retrograde Cholangiopancreatography

Abstract

Background & aims: Disposable, single-use duodenoscopes might reduce outbreaks of infections associated with endoscope reuse. We tested the feasibility, preliminary safety, and performance of a new single-use duodenoscope in patients undergoing endoscopic retrograde cholangiopancreatography (ERCP).

Methods: We conducted a case-series study of the outcomes of ERCP with a single-use duodenoscope from April through May 2019 at 6 academic medical centers. We screened consecutive patients (18 years and older) without alterations in pancreaticobiliary anatomy and enrolled 73 patients into the study. Seven expert endoscopists performed roll-in maneuvers (duodenoscope navigation and visualization of duodenal papilla only) in 13 patients and then ERCPs in the 60 other patients. Outcomes analyzed included completion of ERCP for the intended clinical indication, crossover from a 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 maneuver cases were completed using the single-use duodenoscope. ERCPs were of American Society for Gastrointestinal Endoscopy procedural complexity grade 1 (least complex; 7 patients [11.7%]), grade 2 (26 patients [43.3%]), grade 3 (26 patients [43.3%]), and grade 4 (most complex; 1 patient [1.7%]). Fifty-eight ERCPs (96.7%) were completed using the single-use duodenoscope only and 2 ERCPs (3.3%) were completed using the single-use duodenoscope followed by crossover to a reusable duodenoscope. Median overall satisfaction was 9 out of 10. Three patients developed post-ERCP pancreatitis, 1 patient had post-sphincterotomy bleeding, and 1 patient had worsening of a preexisting infection and required rehospitalization.

Conclusions: In a case-series study, we found that expert endoscopists can complete ERCPs of a wide range of complexity using a single-use duodenoscope for nearly all cases. This alternative might decrease ERCP-related risk of infection. Clinicaltrials.gov no: NCT03701958.

Keywords: Bacterial Drug Resistance; Contamination; Gastrointestinal Endoscopes; Reprocessing.