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

BACKGROUND

 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

 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 endoscope, 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 endoscope. 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.

Informations de copyright

The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution License, permitting unrestricted use, distribution, and reproduction so long as the original work is properly cited. (https://creativecommons.org/licenses/by/4.0/).

Déclaration de conflit d'intérêts

M.J. Bruno has provided consultancy and had support for industry- and investigator-initiated studies for Boston Scientific, Cook Medical, and Pentax Medical, and support for investigator-initiated studies from Mylan, InterScope, and ChiRhoStim. T. Beyna has provided consultancy for Boston Scientific, Olympus, Medtronic, and Microtech Endoscopy. D. Carr-Locke receives royalties from Steris Corporation. P. Chahal has provided consultancy and is on the advisory council for Boston Scientific, and is on the advisory council for Medtronic. G. Costamagna has received grants from Cook Endoscopy, Olympus, and Boston Scientific and has been on advisory committees or review panels for Boston Scientific and Olympus. B. Devereaux has provided consultancy to Olympus, Boston Scientific, and Mylan. M. Giovannini has consultancy agreements with Pentax and Taewoong. C. Khor has provided consultancy for Boston Scientific, Erbe, and Fujifilm. J. Lau is a research consultant for Boston Scientific. G. May is a consultant for Olympus and is a speaker for/on the advisory board for Vantage Endoscopy, Fujifilm, Pentax, Medtronic, and Boston Scientific. V.R. Muthusamy is a consultant for and has received research support from Boston Scientific, is a consultant for Medtronic, and on the advisory board for Motus GI and Endogastric Solutions; he holds stock options in CapsoVision; he was previously a consultant to Medivators and Interpace Diagnostics. S. Patel is a consultant for Boston Scientific, Olympus, Conmed, and AbbVie. B.T. Petersen is an investigator for Boston Scientific and Ambu and has provided consultancy for Olympus and Pentax. D.K. Pleskow has provided consultancy to Boston Scientific, Fuji, and Olympus. I. Raijman is a speaker for/on the advisory board of Boston Scientific, Microtech, and Pentax, has provided consultancy to Olympus, Conmed, Endosound, and Cryo, and is co-owner of EndoRx. A. Repici has received consultancy and speaker's fees from Boston Scientific Corporation. A.S. Ross has provided consultancy to Boston Scientific. D.V. Sejpal has received consultancy fees and research funding frrom Boston Scientific and Olympus. S. Sherman has provided consultancy for Olympus, Boston Scientific, and Cook. U.D. Siddiqui has received research funding from Boston Scientific, consultancy and speaker's fees from Boston Scientific, Cook, Olympus, Medtronic, and ConMed, and speaker's fees from Pinnacle Biologics and Ovesco. J.A. Peetermans and M.J. Rousseau are full-time employees of Boston Scientific. A. Slivka has received research support for IRB-approved studies from Boston Scientific and Olympus. M. Goenka, N. Reddy, and C. Zaidy declare that they have no conflict of interest.