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
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
1046-1055Investigateurs
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.