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, Bret T Petersen, Douglas K Pleskow, Isaac Raijman, D Nageshwar Reddy, Alessandro Repici, Andrew S Ross, Divyesh V Sejpal, Stuart Sherman, Uzma D Siddiqui, Christopher Ziady, Joyce A Peetermans, Matthew J Rousseau, Adam Slivka

Journal: Endoscopy 2023;55(12):1103-1114

PMID: 37463599

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Abstract

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.

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/).

Address: Department of Gastroenterology and Hepatology, Erasmus Medical Center, University Medical Center, Rotterdam, The Netherlands.; Department of Internal Medicine, Evangelisches Krankenhaus Düsseldorf, Düsseldorf, Germany.; Division of Gastroenterology & Hepatology, New York Presbyterian Hospital, Weill Cornell Medicine, New York, New York, USA.; Gastroenterology and Hepatology, Digestive Disease and Surgery Institute, Cleveland Clinic, Cleveland, Ohio, USA.; Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Università Cattolica del Sacro Cuore), Rome, Italy.; Department of Gastroenterology, University of Queensland, Royal Brisbane and Women's Hospital, Brisbane, Australia.; Endoscopy Unit, Institut Paoli-Calmettes, Marseille, France.; Department of Gastroenterology, Apollo Multispecialty Hospitals, Kolkata, India.; Department of Gastroenterology and Hepatology, Singapore General Hospital, Singapore.; Prince of Wales Hospital, Hong Kong, China.; The Centre for Therapeutic Endoscopy and Endoscopic Oncology, Division of Gastroenterology, St. Michael's Hospital, Alberta, Canada.; Vatche and Tamar Manoukian Division of Digestive Diseases, David Geffen School of Medicine at UCLA, University of California, Los Angeles, California, USA.; Division of Gastroenterology, UT Health San Antonio, San Antonio, Texas, USA.; Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA.; Center for Advanced Endoscopy, Division of Gastroenterology, Beth Israel Deaconess Medical Center, and Harvard Medical School, Boston, Massachusetts, USA.; Texas International Endoscopy Center, Houston, Texas, USA.; Asian Institute of Gastroenterology, Hyderabad, India.; Endoscopy Unit, Humanitas Clinical and Research Center IRCCS, Rozzano, Milan, Italy.; Department of Biomedical Sciences, Humanitas University, Rozzano, Milan, Italy.; Department of Gastroenterology, Digestive Disease Institute, Virginia Mason Medical Center, Seattle, Washington.; Digestive Disease Institute, Dignity/CommonSpirit Health, Creighton School of Medicine, Phoenix, Arizona, USA.; Division of Gastroenterology and Hepatology, Department of Medicine, Indiana University, Indianapolis, Indiana, USA.; Center for Endoscopic Research and Therapeutics (CERT), University of Chicago, Chicago, Illinois, USA.; Dr. George Mukhari Academic Medical Center, Pretoria, South Africa.; Endoscopy Division, Boston Scientific Corporation, Marlborough, Massachusetts, USA.; Department of Gastroenterology, Hepatology, and Nutrition, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA.

DOI: 10.1055/a-2131-7180

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MeSH Terms: Adult, Male, Humans, Female, Cholangiopancreatography, Endoscopic Retrograde, Duodenoscopes, Endoscopy, Gastrointestinal, Pancreatitis