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; EXALT Single-use Duodenoscope Study Group

doi:10.1055/a-2131-7180

Endoscopy, Inhaltsverzeichnis

CC BY 4.0 · Endoscopy 2023; 55(12): 1103-1114
DOI: 10.1055/a-2131-7180

Original article

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

Marco J. Bruno

¹Department of Gastroenterology and Hepatology, Erasmus Medical Center, University Medical Center, Rotterdam, The Netherlands

,

Torsten Beyna

²Department of Internal Medicine, Evangelisches Krankenhaus Düsseldorf, Düsseldorf, Germany

,

David Carr-Locke

³Division of Gastroenterology & Hepatology, New York Presbyterian Hospital, Weill Cornell Medicine, New York, New York, USA

,

Prabhleen Chahal

⁴Gastroenterology and Hepatology, Digestive Disease and Surgery Institute, Cleveland Clinic, Cleveland, Ohio, USA

,

Guido Costamagna

⁵Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Università Cattolica del Sacro Cuore), Rome, Italy

,

Benedict Devereaux

⁶Department of Gastroenterology, University of Queensland, Royal Brisbane and Women’s Hospital, Brisbane, Australia

,

Marc Giovannini

⁷Endoscopy Unit, Institut Paoli-Calmettes, Marseille, France

,

Mahesh K. Goenka

⁸Department of Gastroenterology, Apollo Multispecialty Hospitals, Kolkata, India

,

Christopher Khor

⁹Department of Gastroenterology and Hepatology, Singapore General Hospital, Singapore

,

James Lau

¹⁰Prince of Wales Hospital, Hong Kong, China

,

Gary May

¹¹The Centre for Therapeutic Endoscopy and Endoscopic Oncology, Division of Gastroenterology, St. Michael’s Hospital, Alberta, Canada

,

V. Raman Muthusamy

¹²Vatche and Tamar Manoukian Division of Digestive Diseases, David Geffen School of Medicine at UCLA, University of California, Los Angeles, California, USA

,

Sandeep Patel

¹³Division of Gastroenterology, UT Health San Antonio, San Antonio, Texas, USA

,

Bret T. Petersen

¹⁴Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA

,

Douglas K. Pleskow

¹⁵Center for Advanced Endoscopy, Division of Gastroenterology, Beth Israel Deaconess Medical Center, and Harvard Medical School, Boston, Massachusetts, USA

,

Isaac Raijman

¹⁶Texas International Endoscopy Center, Houston, Texas, USA

,

D. Nageshwar Reddy

¹⁷Asian Institute of Gastroenterology, Hyderabad, India

,

Alessandro Repici

¹⁸Endoscopy Unit, Humanitas Clinical and Research Center IRCCS, Rozzano, Milan, Italy

¹⁹Department of Biomedical Sciences, Humanitas University, Rozzano, Milan, Italy

,

Andrew S. Ross

²⁰Department of Gastroenterology, Digestive Disease Institute, Virginia Mason Medical Center, Seattle, Washington

,

Divyesh V. Sejpal

²¹Digestive Disease Institute, Dignity/CommonSpirit Health, Creighton School of Medicine, Phoenix, Arizona, USA

,

Stuart Sherman^*

²²Division of Gastroenterology and Hepatology, Department of Medicine, Indiana University, Indianapolis, Indiana, USA

,

Uzma D. Siddiqui

²³Center for Endoscopic Research and Therapeutics (CERT), University of Chicago, Chicago, Illinois, USA

,

Christopher Ziady

²⁴Dr. George Mukhari Academic Medical Center, Pretoria, South Africa

,

Joyce A. Peetermans

²⁵Endoscopy Division, Boston Scientific Corporation, Marlborough, Massachusetts, USA

,

Matthew J. Rousseau

²⁵Endoscopy Division, Boston Scientific Corporation, Marlborough, Massachusetts, USA

,

Adam Slivka

²⁶Department of Gastroenterology, Hepatology, and Nutrition, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA

,

EXALT Single-use Duodenoscope Study Group

› Institutsangaben

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.

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Referenzen

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