TY - JOUR
T1 - Comparing the Safety and Efficacy of Two Commercially Available Single-Use Duodenoscopes
T2 - A Multicenter Study
AU - Shahid, Haroon M.
AU - Bareket, Romy
AU - Tyberg, Amy
AU - Sarkar, Avik
AU - Simon, Alexa
AU - Gurram, Krishna
AU - Gress, Frank G.
AU - Bhenswala, Prashant
AU - Chalikonda, Divya
AU - Loren, David E.
AU - Kowalski, Thomas E.
AU - Kumar, Anand
AU - Vareedayah, Ashley A.
AU - Abhyankar, Priya R.
AU - Parker, Kasey
AU - Gabr, Moamen M.
AU - Nieto, Jose
AU - De Latour, Rabia
AU - Zolotarevsky, Mitchelle
AU - Barber, Jeremy
AU - Zolotarevsky, Eugene
AU - Vazquez-Sequeiros, Enrique
AU - Gaidhane, Monica
AU - Andalib, Iman
AU - Kahaleh, Michel
N1 - Publisher Copyright:
© 2022 Wolters Kluwer Health, Inc. All rights reserved.
PY - 2023/9/24
Y1 - 2023/9/24
N2 - Introduction: Single-use disposable duodenoscopes (SDD) have been developed to mitigate infectious risks related to reusable duodenoscopes. The aim of this study is to compare the safety and efficacy of the two available SDDs in the United States. Methods: We conducted a comparative study of 2 SDD in consecutive ERCP procedures performed by expert endoscopists from 9 academic centers. Performance ratings, procedure details, and adverse events were collected. Results: A total of 201 patients were included: 129 patients underwent ERCP with Exalt (mean age 63, Males- 66 (51%), 72 with aScope Duodeno (mean age 65, males=30 (42%). A majority of endoscopists had performed >2000 ERCPs in both groups (71% Exalt, 93% aScope Duodeno). Technical success was 92% in both groups (n=119 Exalt-group, n=66 aScope-Duodeno-group). The procedural complexity for the ERCP cases performed were: Grade 1: 35 cases (18%), Grade 2: 83 cases (41%), Grade 3: 65 cases (32%), and Grade 4: 18 cases (9%). Thirteen patients (10%) from the Exalt group and 16 patients (22%) from the aScope Duodeno group required conversion to a reusable duodenoscope. On a scale of 1 to 5, Exalt and aScope Duodeno, respectively, were rated: 2.31 versus 2.60 for location and visualization quality, 1.38 versus 1.57 for maneuverability based on papillary orientation, 1.48 versus 1.15 for suction/air control, and 2.31 versus 2.34 for elevator efficiency. None of the adverse events were related to the SDDs. Conclusions: The 2 SDDs were comparable. Further ongoing enhancements to these devices will improve maneuverability and clinical effectiveness.
AB - Introduction: Single-use disposable duodenoscopes (SDD) have been developed to mitigate infectious risks related to reusable duodenoscopes. The aim of this study is to compare the safety and efficacy of the two available SDDs in the United States. Methods: We conducted a comparative study of 2 SDD in consecutive ERCP procedures performed by expert endoscopists from 9 academic centers. Performance ratings, procedure details, and adverse events were collected. Results: A total of 201 patients were included: 129 patients underwent ERCP with Exalt (mean age 63, Males- 66 (51%), 72 with aScope Duodeno (mean age 65, males=30 (42%). A majority of endoscopists had performed >2000 ERCPs in both groups (71% Exalt, 93% aScope Duodeno). Technical success was 92% in both groups (n=119 Exalt-group, n=66 aScope-Duodeno-group). The procedural complexity for the ERCP cases performed were: Grade 1: 35 cases (18%), Grade 2: 83 cases (41%), Grade 3: 65 cases (32%), and Grade 4: 18 cases (9%). Thirteen patients (10%) from the Exalt group and 16 patients (22%) from the aScope Duodeno group required conversion to a reusable duodenoscope. On a scale of 1 to 5, Exalt and aScope Duodeno, respectively, were rated: 2.31 versus 2.60 for location and visualization quality, 1.38 versus 1.57 for maneuverability based on papillary orientation, 1.48 versus 1.15 for suction/air control, and 2.31 versus 2.34 for elevator efficiency. None of the adverse events were related to the SDDs. Conclusions: The 2 SDDs were comparable. Further ongoing enhancements to these devices will improve maneuverability and clinical effectiveness.
KW - ASGE
KW - ERCP
KW - Single-use disposable
KW - duodenoscope
KW - infection
KW - reusable duodenoscope
KW - Humans
KW - Middle Aged
KW - Male
KW - Cholangiopancreatography, Endoscopic Retrograde/adverse effects
KW - Aged
KW - Duodenoscopes/adverse effects
UR - http://www.scopus.com/inward/record.url?scp=85151247250&partnerID=8YFLogxK
UR - https://www.webofscience.com/api/gateway?GWVersion=2&SrcApp=purepublist2023&SrcAuth=WosAPI&KeyUT=WOS:001049302200008&DestLinkType=FullRecord&DestApp=WOS
U2 - 10.1097/MCG.0000000000001752
DO - 10.1097/MCG.0000000000001752
M3 - Article
C2 - 35997700
SN - 0192-0790
VL - 57
SP - 798
EP - 803
JO - Journal of Clinical Gastroenterology
JF - Journal of Clinical Gastroenterology
IS - 8
ER -