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

Marco J. Bruno, Torsten Beyna, David Carr-Locke, Prabhleen Chahal, Guido Costamagna, Benedict Devereaux, Marc Giovannini, Mahesh K. Goenka, Christopher Khor, James Lau, Gary May, V. Raman Muthusamy, Sandeep Patel, Brett Petersen, Douglas K. Pleskow, Isaac Raijman, D. Nageshwar Reddy, Alessandro Repici18'19, Andrews Ross, Divyesh V. SejpalStuart Sherman, Uzma D. Siddiqui, Christopher Ziady, Joyce A. Peetermans, Matthew J. Rousseau, Adam Slivka

Research output: Contribution to journalArticlepeer-review

5 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)1103-1114
Number of pages12
JournalEndoscopy
Volume55
Issue number12
DOIs
StatePublished - Mar 13 2023

ASJC Scopus subject areas

  • Gastroenterology

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