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

Adam Slivka; Andrew S. Ross; EXALT Single-use Duodenoscope Study Group; 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

doi:10.1016/j.gie.2021.06.017

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

Adam Slivka^*, Andrew S. Ross, EXALT Single-use Duodenoscope Study Group, 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

^*Corresponding author for this work

Gastroenterology & Hepatology

Research output: Contribution to journal › Article › Academic › peer-review

23 Citations (Scopus)

19 Downloads (Pure)

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.)

Original language	English
Pages (from-to)	1046-1055
Number of pages	10
Journal	Gastrointestinal Endoscopy
Volume	94
Issue number	6
DOIs	https://doi.org/10.1016/j.gie.2021.06.017
Publication status	Published - 26 Jun 2021

Bibliographical note

Funding Information:
DISCLOSURE: The following authors disclosed financial relationships: A. Slivka: Research funding from Boston Scientific Corporation and Olympus. A. S. Ross: Consultant for and research funding from Boston Scientific Corporation. D. V. Sejpal: Consultant for Boston Scientific Corporation and Olympus; research funding from Boston Scientific Corporation. B. T. Petersen: Investigator for Boston Scientific Corporation; consultant for Olympus America and Ambu. M. J. Bruno: Research funding from Boston Scientific Corporation, Cook Medical, 3M, Pentax Medical, Mylan, and InterScope; consultant for Boston Scientific Corporation, Cook Medical, and Pentax Medical. D. K. Pleskow: Consultant for and research funding from Boston Scientific Corporation; consultant for Olympus, Fuji, and Medtronic. V. R. Muthusamy: Consultant for Boston Scientific Corporation, Medtronic, Medivators, and Interpace; research funding from Boston Scientific Corporation and Medtronic; honoraria from Ethicon/Torax; stockholder in CapsoVision. J.-W. Poley: Consultant for Boston Scientific Corporation, Cook Medical, and Pentax Medical. J. M. Cohen, A. M. Thaker: Consultant for Boston Scientific Corporation. J. A. Peetermans, M. J. Rousseau, G. P. Tirrell: Full-time employees of Boston Scientific Corporation. R. A. Kozarek: Research funding from Boston Scientific Corporation. All other authors disclosed no financial relationships. Research support for this study was provided by Boston Scientific Corporation.

Funding Information:
DISCLOSURE: The following authors disclosed financial relationships: A. Slivka: Research funding from Boston Scientific Corporation and Olympus. A. S. Ross: Consultant for and research funding from Boston Scientific Corporation. D. V. Sejpal: Consultant for Boston Scientific Corporation and Olympus; research funding from Boston Scientific Corporation. B. T. Petersen: Investigator for Boston Scientific Corporation; consultant for Olympus America and Ambu. M. J. Bruno: Research funding from Boston Scientific Corporation, Cook Medical, 3M, Pentax Medical, Mylan, and InterScope; consultant for Boston Scientific Corporation, Cook Medical, and Pentax Medical. D. K. Pleskow: Consultant for and research funding from Boston Scientific Corporation; consultant for Olympus, Fuji, and Medtronic. V. R. Muthusamy: Consultant for Boston Scientific Corporation, Medtronic, Medivators, and Interpace; research funding from Boston Scientific Corporation and Medtronic; honoraria from Ethicon/Torax; stockholder in CapsoVision. J.-W. Poley: Consultant for Boston Scientific Corporation, Cook Medical, and Pentax Medical. J. M. Cohen, A. M. Thaker: Consultant for Boston Scientific Corporation. J. A. Peetermans, M. J. Rousseau, G. P. Tirrell: Full-time employees of Boston Scientific Corporation. R. A. Kozarek: Research funding from Boston Scientific Corporation. All other authors disclosed no financial relationships. Research support for this study was provided by Boston Scientific Corporation.

Publisher Copyright:
© 2021 American Society for Gastrointestinal Endoscopy

Access to Document

10.1016/j.gie.2021.06.017Licence: CC BY-NC-ND

PIIS0016510721014644Final published version, 918 KBLicence: CC BY-NC-ND

Cite this

Slivka, A., Ross, A. S., EXALT Single-use Duodenoscope Study Group, Sejpal, D. V., Petersen, B. T., Bruno, M. J., Pleskow, D. K., Muthusamy, V. R., Chennat, J. S., Krishnamoorthi, R., Lee, C., Martin, J. A., Poley, J. W., Cohen, J. M., Thaker, A. M., Peetermans, J. A., Rousseau, M. J., Tirrell, G. P., & Kozarek, R. A. (2021). Single-use duodenoscope for ERCP performed by endoscopists with a range of experience in procedures of variable complexity. Gastrointestinal Endoscopy, 94(6), 1046-1055. https://doi.org/10.1016/j.gie.2021.06.017

@article{d896ed068bdb4c53ad6ae7ea4b78ca00,

title = "Single-use duodenoscope for ERCP performed by endoscopists with a range of experience in procedures of variable complexity",

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.)",

author = "Adam Slivka and Ross, {Andrew S.} and {EXALT Single-use Duodenoscope Study Group} and Sejpal, {Divyesh V.} and Petersen, {Bret T.} and Bruno, {Marco J.} and Pleskow, {Douglas K.} and Muthusamy, {V. Raman} and Chennat, {Jennifer S.} and Rajesh Krishnamoorthi and Calvin Lee and Martin, {John A.} and Poley, {Jan Werner} and Cohen, {Jonah M.} and Thaker, {Adarsh M.} and Peetermans, {Joyce A.} and Rousseau, {Matthew J.} and Tirrell, {Gregory P.} and Kozarek, {Richard A.}",

note = "Funding Information: DISCLOSURE: The following authors disclosed financial relationships: A. Slivka: Research funding from Boston Scientific Corporation and Olympus. A. S. Ross: Consultant for and research funding from Boston Scientific Corporation. D. V. Sejpal: Consultant for Boston Scientific Corporation and Olympus; research funding from Boston Scientific Corporation. B. T. Petersen: Investigator for Boston Scientific Corporation; consultant for Olympus America and Ambu. M. J. Bruno: Research funding from Boston Scientific Corporation, Cook Medical, 3M, Pentax Medical, Mylan, and InterScope; consultant for Boston Scientific Corporation, Cook Medical, and Pentax Medical. D. K. Pleskow: Consultant for and research funding from Boston Scientific Corporation; consultant for Olympus, Fuji, and Medtronic. V. R. Muthusamy: Consultant for Boston Scientific Corporation, Medtronic, Medivators, and Interpace; research funding from Boston Scientific Corporation and Medtronic; honoraria from Ethicon/Torax; stockholder in CapsoVision. J.-W. Poley: Consultant for Boston Scientific Corporation, Cook Medical, and Pentax Medical. J. M. Cohen, A. M. Thaker: Consultant for Boston Scientific Corporation. J. A. Peetermans, M. J. Rousseau, G. P. Tirrell: Full-time employees of Boston Scientific Corporation. R. A. Kozarek: Research funding from Boston Scientific Corporation. All other authors disclosed no financial relationships. Research support for this study was provided by Boston Scientific Corporation. Funding Information: DISCLOSURE: The following authors disclosed financial relationships: A. Slivka: Research funding from Boston Scientific Corporation and Olympus. A. S. Ross: Consultant for and research funding from Boston Scientific Corporation. D. V. Sejpal: Consultant for Boston Scientific Corporation and Olympus; research funding from Boston Scientific Corporation. B. T. Petersen: Investigator for Boston Scientific Corporation; consultant for Olympus America and Ambu. M. J. Bruno: Research funding from Boston Scientific Corporation, Cook Medical, 3M, Pentax Medical, Mylan, and InterScope; consultant for Boston Scientific Corporation, Cook Medical, and Pentax Medical. D. K. Pleskow: Consultant for and research funding from Boston Scientific Corporation; consultant for Olympus, Fuji, and Medtronic. V. R. Muthusamy: Consultant for Boston Scientific Corporation, Medtronic, Medivators, and Interpace; research funding from Boston Scientific Corporation and Medtronic; honoraria from Ethicon/Torax; stockholder in CapsoVision. J.-W. Poley: Consultant for Boston Scientific Corporation, Cook Medical, and Pentax Medical. J. M. Cohen, A. M. Thaker: Consultant for Boston Scientific Corporation. J. A. Peetermans, M. J. Rousseau, G. P. Tirrell: Full-time employees of Boston Scientific Corporation. R. A. Kozarek: Research funding from Boston Scientific Corporation. All other authors disclosed no financial relationships. Research support for this study was provided by Boston Scientific Corporation. Publisher Copyright: {\textcopyright} 2021 American Society for Gastrointestinal Endoscopy",

year = "2021",

month = jun,

day = "26",

doi = "10.1016/j.gie.2021.06.017",

language = "English",

volume = "94",

pages = "1046--1055",

journal = "Gastrointestinal Endoscopy",

issn = "0016-5107",

publisher = "Elsevier Inc.",

number = "6",

}

Slivka, A, Ross, AS, EXALT Single-use Duodenoscope Study Group, Sejpal, DV, Petersen, BT, Bruno, MJ, Pleskow, DK, Muthusamy, VR, Chennat, JS, Krishnamoorthi, R, Lee, C, Martin, JA, Poley, JW, Cohen, JM, Thaker, AM, Peetermans, JA, Rousseau, MJ, Tirrell, GP & Kozarek, RA 2021, 'Single-use duodenoscope for ERCP performed by endoscopists with a range of experience in procedures of variable complexity', Gastrointestinal Endoscopy, vol. 94, no. 6, pp. 1046-1055. https://doi.org/10.1016/j.gie.2021.06.017

TY - JOUR

T1 - Single-use duodenoscope for ERCP performed by endoscopists with a range of experience in procedures of variable complexity

AU - Slivka, Adam

AU - Ross, Andrew S.

AU - EXALT Single-use Duodenoscope Study Group

AU - Sejpal, Divyesh V.

AU - Petersen, Bret T.

AU - Bruno, Marco J.

AU - Pleskow, Douglas K.

AU - Muthusamy, V. Raman

AU - Chennat, Jennifer S.

AU - Krishnamoorthi, Rajesh

AU - Lee, Calvin

AU - Martin, John A.

AU - Poley, Jan Werner

AU - Cohen, Jonah M.

AU - Thaker, Adarsh M.

AU - Peetermans, Joyce A.

AU - Rousseau, Matthew J.

AU - Tirrell, Gregory P.

AU - Kozarek, Richard A.

N1 - Funding Information: DISCLOSURE: The following authors disclosed financial relationships: A. Slivka: Research funding from Boston Scientific Corporation and Olympus. A. S. Ross: Consultant for and research funding from Boston Scientific Corporation. D. V. Sejpal: Consultant for Boston Scientific Corporation and Olympus; research funding from Boston Scientific Corporation. B. T. Petersen: Investigator for Boston Scientific Corporation; consultant for Olympus America and Ambu. M. J. Bruno: Research funding from Boston Scientific Corporation, Cook Medical, 3M, Pentax Medical, Mylan, and InterScope; consultant for Boston Scientific Corporation, Cook Medical, and Pentax Medical. D. K. Pleskow: Consultant for and research funding from Boston Scientific Corporation; consultant for Olympus, Fuji, and Medtronic. V. R. Muthusamy: Consultant for Boston Scientific Corporation, Medtronic, Medivators, and Interpace; research funding from Boston Scientific Corporation and Medtronic; honoraria from Ethicon/Torax; stockholder in CapsoVision. J.-W. Poley: Consultant for Boston Scientific Corporation, Cook Medical, and Pentax Medical. J. M. Cohen, A. M. Thaker: Consultant for Boston Scientific Corporation. J. A. Peetermans, M. J. Rousseau, G. P. Tirrell: Full-time employees of Boston Scientific Corporation. R. A. Kozarek: Research funding from Boston Scientific Corporation. All other authors disclosed no financial relationships. Research support for this study was provided by Boston Scientific Corporation. Funding Information: DISCLOSURE: The following authors disclosed financial relationships: A. Slivka: Research funding from Boston Scientific Corporation and Olympus. A. S. Ross: Consultant for and research funding from Boston Scientific Corporation. D. V. Sejpal: Consultant for Boston Scientific Corporation and Olympus; research funding from Boston Scientific Corporation. B. T. Petersen: Investigator for Boston Scientific Corporation; consultant for Olympus America and Ambu. M. J. Bruno: Research funding from Boston Scientific Corporation, Cook Medical, 3M, Pentax Medical, Mylan, and InterScope; consultant for Boston Scientific Corporation, Cook Medical, and Pentax Medical. D. K. Pleskow: Consultant for and research funding from Boston Scientific Corporation; consultant for Olympus, Fuji, and Medtronic. V. R. Muthusamy: Consultant for Boston Scientific Corporation, Medtronic, Medivators, and Interpace; research funding from Boston Scientific Corporation and Medtronic; honoraria from Ethicon/Torax; stockholder in CapsoVision. J.-W. Poley: Consultant for Boston Scientific Corporation, Cook Medical, and Pentax Medical. J. M. Cohen, A. M. Thaker: Consultant for Boston Scientific Corporation. J. A. Peetermans, M. J. Rousseau, G. P. Tirrell: Full-time employees of Boston Scientific Corporation. R. A. Kozarek: Research funding from Boston Scientific Corporation. All other authors disclosed no financial relationships. Research support for this study was provided by Boston Scientific Corporation. Publisher Copyright: © 2021 American Society for Gastrointestinal Endoscopy

PY - 2021/6/26

Y1 - 2021/6/26

N2 - 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.)

AB - 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.)

UR - http://www.scopus.com/inward/record.url?scp=85114988821&partnerID=8YFLogxK

U2 - 10.1016/j.gie.2021.06.017

DO - 10.1016/j.gie.2021.06.017

M3 - Article

C2 - 34186052

AN - SCOPUS:85114988821

SN - 0016-5107

VL - 94

SP - 1046

EP - 1055

JO - Gastrointestinal Endoscopy

JF - Gastrointestinal Endoscopy

IS - 6

ER -

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

Abstract

Bibliographical note

Access to Document

Other files and links

Fingerprint

Cite this