Global prospective case series of ERCPs using a single-use duodenoscope

Abstract

Background The first commercialized single-use duode-noscope was cleared by the US Food and Drug Administration in December 2019. Data regarding endoscopic retrograde cholangiopancreatography (ERCP) using a single-use duodenoscope are needed on a broader range of cases conducted by endoscopists with varying levels of experience in a wide range of geographic areas. Methods 61 endoscopists at 22 academic centers in 11 countries performed ERCP procedures in adult patients aged > 18. Outcomes included ERCP completion for the intended indication, rate of crossover to a reusable endo-scope, device performance ratings, and serious adverse events (SAEs). Results Among 551 patients, 236 (42.8%) were aged >65, 281 (51.0%) were men, and 256 (46.5%) had their procedure as an inpatient. ERCPs included 196 (35.6%) with American Society for Gastrointestinal Endoscopy complexity of grades 3-4. A total of 529 ERCPs (96.0%) were completed: 503 (91.3%) using only the single-use duodenoscope, and 26 (4.7%) with crossover to a reusable endo-scope. There were 22 ERCPs (4.0%) that were not completed, of which 11 (2.0%) included a crossover and 11 (2.0%) were aborted cases (no crossover). Median ERCP completion time was 24.0 minutes. Median overall satisfaction with the single-use duodenoscope was 8.0 (scale of 1 to 10 [best]). SAEs were reported in 43 patients (7.8%), including 17 (3.1 %) who developed post-ERCP pancreatitis. Conclusions In academic medical centers over a wide geographic distribution, endoscopists with varying levels of experience using the first marketed single-use duodenoscope had good ERCP procedural success and reported high performance ratings for this device.