Single-use duodenoscope for ERCP performed by endoscopists with a range of experience in procedures of variable complexity
Adam Slivka, Andrew S Ross, Divyesh V Sejpal, Bret T Petersen, Marco J Bruno, Douglas K Pleskow, V Raman Muthusamy, Jennifer S Chennat, Rajesh Krishnamoorthi, Calvin Lee, John A Martin, Jan-Werner Poley, Jonah M Cohen, Adarsh M Thaker, Joyce A Peetermans, Matthew J Rousseau, Gregory P Tirrell, Richard A Kozarek, EXALT Single-use Duodenoscope Study Group, Adam Slivka, Jennifer S Chennat, Asif Khalid, Rohit Das, Harkirat Singh, Kishore Vipperla, Divyesh V Sejpal, Calvin Lee, Andrew Antony, Richard A Kozarek, Andrew S Ross, Jun-Ho Choi, Michael Larsen, Joanna Law, Rajesh Krishnamoorthi, Jagpal Klair, V Raman Muthusamy, Adarsh Thaker, Bret T Petersen, John A Martin, Barham Abu Dayyeh, Vinay Chandrasekhara, Michael Levy, Ryan Law, Douglas K Pleskow, Jonah M Cohen, Marco J Bruno, Jan-Werner Poley, Joyce A Peetermans, Matthew J Rousseau, Gregory P Tirrell, Jeff Insull, Adam Slivka, Andrew S Ross, Divyesh V Sejpal, Bret T Petersen, Marco J Bruno, Douglas K Pleskow, V Raman Muthusamy, Jennifer S Chennat, Rajesh Krishnamoorthi, Calvin Lee, John A Martin, Jan-Werner Poley, Jonah M Cohen, Adarsh M Thaker, Joyce A Peetermans, Matthew J Rousseau, Gregory P Tirrell, Richard A Kozarek, EXALT Single-use Duodenoscope Study Group, Adam Slivka, Jennifer S Chennat, Asif Khalid, Rohit Das, Harkirat Singh, Kishore Vipperla, Divyesh V Sejpal, Calvin Lee, Andrew Antony, Richard A Kozarek, Andrew S Ross, Jun-Ho Choi, Michael Larsen, Joanna Law, Rajesh Krishnamoorthi, Jagpal Klair, V Raman Muthusamy, Adarsh Thaker, Bret T Petersen, John A Martin, Barham Abu Dayyeh, Vinay Chandrasekhara, Michael Levy, Ryan Law, Douglas K Pleskow, Jonah M Cohen, Marco J Bruno, Jan-Werner Poley, Joyce A Peetermans, Matthew J Rousseau, Gregory P Tirrell, Jeff Insull
Abstract
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.).
Copyright © 2021 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.
Source: PubMed