Global prospective case series of ERCP using a single-use duodenoscope.
Article
Overview
abstract
BACKGROUND & AIMS The first commercialized single-use duodenoscope 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 Sixty-one endoscopists at 22 academic centers in 11 countries performed ERCP procedures in adult patients aged 18 and older. Outcomes included ERCP completion for the intended indication, rate of crossover to a reusable endoscope, device performance ratings, and serious adverse events (SAEs). RESULTS Among 551 patients, 236 (42.8%) were over age 65, 281 (51.0%) were male, and 256 (46.5%) had their procedure as an inpatient. ERCPs included 196 (35.6%) with American Society for Gastrointestinal Endoscopy grades 3-4 complexity. Five hundred and twenty-nine (96.0%) ERCPs were completed-503 (91.3%) using only the single-use duodenoscope, and 26 (4.7%) with crossover to a reusable endoscope. Twenty-two (4.0%) ERCPs 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 (7.8%) patients, including 17 (3.1%) who developed post-ERCP pancreatitis. CONCLUSIONS In academic medical centers with 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. (Clinicaltrials.gov, Number:04103749).
