Single-use duodenoscope for ERCP performed by endoscopists with a range of experience in procedures of variable complexity.


Journal

Gastrointestinal endoscopy
ISSN: 1097-6779
Titre abrégé: Gastrointest Endosc
Pays: United States
ID NLM: 0010505

Informations de publication

Date de publication:
12 2021
Historique:
received: 12 03 2021
accepted: 18 06 2021
pubmed: 30 6 2021
medline: 4 1 2022
entrez: 29 6 2021
Statut: ppublish

Résumé

Expert endoscopists previously reported ERCP outcomes for the first commercialized single-use duodenoscope. We aimed to document usability of this device by endoscopists with different levels of ERCP experience. Fourteen "expert" (>2000 lifetime ERCPs) and 5 "less-expert" endoscopists performed consecutive ERCPs in patients without altered pancreaticobiliary anatomy. Outcomes included ERCP completion for the intended indication, rate of crossover to another endoscope, device performance ratings, and serious adverse events. Two hundred ERCPs including 81 (40.5%) with high complexity (American Society for Gastrointestinal Endoscopy grades 3-4) were performed. Crossover rate (11.3% vs 2.5%, P = .131), ERCP completion rate (regardless of crossovers) (96.3% vs 97.5%, P = .999), median ERCP completion time (25.0 vs 28.5 minutes, P = .130), mean cannulation attempts (2.8 vs 2.8, P = .954), and median overall satisfaction with the single-use duodenoscope (8.0 vs 8.0 [range, 1.0-10.0], P = .840) were similar for expert versus less-expert endoscopists, respectively. The same metrics were similar by procedural complexity except for shorter median completion time for grades 1 to 2 versus grades 3 to 4 (P < .001). Serious adverse events were reported in 13 patients (6.5%). In consecutive ERCPs including high complexity procedures, endoscopists with varying ERCP experience had good procedural success and reported high device performance ratings. (Clinical trial registration number: NCT04223830.).

Sections du résumé

BACKGROUND AND AIMS
Expert endoscopists previously reported ERCP outcomes for the first commercialized single-use duodenoscope. We aimed to document usability of this device by endoscopists with different levels of ERCP experience.
METHODS
Fourteen "expert" (>2000 lifetime ERCPs) and 5 "less-expert" endoscopists performed consecutive ERCPs in patients without altered pancreaticobiliary anatomy. Outcomes included ERCP completion for the intended indication, rate of crossover to another endoscope, device performance ratings, and serious adverse events.
RESULTS
Two hundred ERCPs including 81 (40.5%) with high complexity (American Society for Gastrointestinal Endoscopy grades 3-4) were performed. Crossover rate (11.3% vs 2.5%, P = .131), ERCP completion rate (regardless of crossovers) (96.3% vs 97.5%, P = .999), median ERCP completion time (25.0 vs 28.5 minutes, P = .130), mean cannulation attempts (2.8 vs 2.8, P = .954), and median overall satisfaction with the single-use duodenoscope (8.0 vs 8.0 [range, 1.0-10.0], P = .840) were similar for expert versus less-expert endoscopists, respectively. The same metrics were similar by procedural complexity except for shorter median completion time for grades 1 to 2 versus grades 3 to 4 (P < .001). Serious adverse events were reported in 13 patients (6.5%).
CONCLUSIONS
In consecutive ERCPs including high complexity procedures, endoscopists with varying ERCP experience had good procedural success and reported high device performance ratings. (Clinical trial registration number: NCT04223830.).

Identifiants

pubmed: 34186052
pii: S0016-5107(21)01464-4
doi: 10.1016/j.gie.2021.06.017
pii:
doi:

Banques de données

ClinicalTrials.gov
['NCT04223830']

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

1046-1055

Investigateurs

Adam Slivka (A)
Jennifer S Chennat (JS)
Asif Khalid (A)
Rohit Das (R)
Harkirat Singh (H)
Kishore Vipperla (K)
Divyesh V Sejpal (DV)
Calvin Lee (C)
Andrew Antony (A)
Richard A Kozarek (RA)
Andrew S Ross (AS)
Jun-Ho Choi (JH)
Michael Larsen (M)
Joanna Law (J)
Rajesh Krishnamoorthi (R)
Jagpal Klair (J)
V Raman Muthusamy (VR)
Adarsh Thaker (A)
Bret T Petersen (BT)
John A Martin (JA)
Barham Abu Dayyeh (B)
Vinay Chandrasekhara (V)
Michael Levy (M)
Ryan Law (R)
Douglas K Pleskow (DK)
Jonah M Cohen (JM)
Marco J Bruno (MJ)
Jan-Werner Poley (JW)
Joyce A Peetermans (JA)
Matthew J Rousseau (MJ)
Gregory P Tirrell (GP)
Jeff Insull (J)

Commentaires et corrections

Type : CommentIn

Informations de copyright

Copyright © 2021 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.

Auteurs

Adam Slivka (A)

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

Andrew S Ross (AS)

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

Divyesh V Sejpal (DV)

Division of Gastroenterology, Zucker School of Medicine at Hofstra/Northwell, North Shore University Hospital, Manhasset, New York, USA.

Bret T Petersen (BT)

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

Marco J Bruno (MJ)

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

Douglas K Pleskow (DK)

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

V Raman Muthusamy (VR)

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

Jennifer S Chennat (JS)

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

Rajesh Krishnamoorthi (R)

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

Calvin Lee (C)

Division of Gastroenterology, Zucker School of Medicine at Hofstra/Northwell, North Shore University Hospital, Manhasset, New York, USA.

John A Martin (JA)

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

Jan-Werner Poley (JW)

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

Jonah M Cohen (JM)

Division of Gastroenterology, Massachusetts General Hospital, and Harvard Medical School, Boston, Massachusetts, USA.

Adarsh M Thaker (AM)

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

Joyce A Peetermans (JA)

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

Matthew J Rousseau (MJ)

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

Gregory P Tirrell (GP)

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

Richard A Kozarek (RA)

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

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