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

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)

Environmental footprint and material composition comparison of single-use and reusable duodenoscopes

“…The largest cohort studying ERCP-related adverse events with SDs showed an overall infection rate of 1.63% [25], which is similar to the classic analysis by Andriulli et al with 16,855 patients (1.44%) [26]. The comparable infection rate also shows that endogenous infection can still occur with the use of a SD, so the procedure-related infection rate is not guaranteed to be lower than the rate for reusable duodenoscopes [25].…”

Single‐use accessories and endoscopes in the era of sustainability and climate change—A balancing act

“…Multiple studies have confirmed that SUDs are associated with high cannulation rates, technical performance, and safety profile (Table 2). 26,28 20–25,27 A recent systematic review and meta‐analysis analyzed the technical performance and safety of ERCPs using SUDs 28 . The pooled rate of successful cannulation was 95% and sphincterotomy could be successfully performed in all cases.…”

Single-use duodenoscopes: is performance enough? Time to include sustainability as a prerequisite in clinical practice

“…In this issue of Endoscopy, Bruno et al [9] present the results of the largest multicentric international case series on the use of single-use duodenoscopes for endoscopic retrograde cholangiopancreatography (ERCP) procedures. The study was conducted between 2019 and 2022 and included a total of 551 procedures, performed by 61 endoscopists at 22 academic centers from 11 different countries.…”