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Global prospective case series of ERCPs using a single-use duodenoscope
Background The first commercialized single-use duodenoscope was cleared by the US Food and Drug Administration in December 2019. Data regarding endoscopic retrograde cholangiopancreatography (ERCP) using a single-use duodenoscope are needed on a broader range of cases conducted by endoscopists with...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Georg Thieme Verlag KG
2023
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10684334/ https://www.ncbi.nlm.nih.gov/pubmed/37463599 http://dx.doi.org/10.1055/a-2131-7180 |
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author | Bruno, Marco J. Beyna, Torsten Carr-Locke, David Chahal, Prabhleen Costamagna, Guido Devereaux, Benedict Giovannini, Marc Goenka, Mahesh K. Khor, Christopher Lau, James May, Gary Muthusamy, V. Raman Patel, Sandeep Petersen, Bret T. Pleskow, Douglas K. Raijman, Isaac Reddy, D. Nageshwar Repici, Alessandro Ross, Andrew S. Sejpal, Divyesh V. Sherman, Stuart Siddiqui, Uzma D. Ziady, Christopher Peetermans, Joyce A. Rousseau, Matthew J. Slivka, Adam |
author_facet | Bruno, Marco J. Beyna, Torsten Carr-Locke, David Chahal, Prabhleen Costamagna, Guido Devereaux, Benedict Giovannini, Marc Goenka, Mahesh K. Khor, Christopher Lau, James May, Gary Muthusamy, V. Raman Patel, Sandeep Petersen, Bret T. Pleskow, Douglas K. Raijman, Isaac Reddy, D. Nageshwar Repici, Alessandro Ross, Andrew S. Sejpal, Divyesh V. Sherman, Stuart Siddiqui, Uzma D. Ziady, Christopher Peetermans, Joyce A. Rousseau, Matthew J. Slivka, Adam |
author_sort | Bruno, Marco J. |
collection | PubMed |
description | Background The first commercialized single-use duodenoscope was cleared by the US Food and Drug Administration in December 2019. Data regarding endoscopic retrograde cholangiopancreatography (ERCP) using a single-use duodenoscope are needed on a broader range of cases conducted by endoscopists with varying levels of experience in a wide range of geographic areas. Methods 61 endoscopists at 22 academic centers in 11 countries performed ERCP procedures in adult patients aged ≥ 18. Outcomes included ERCP completion for the intended indication, rate of crossover to a reusable endoscope, device performance ratings, and serious adverse events (SAEs). Results Among 551 patients, 236 (42.8 %) were aged > 65, 281 (51.0 %) were men, and 256 (46.5 %) had their procedure as an inpatient. ERCPs included 196 (35.6 %) with American Society for Gastrointestinal Endoscopy complexity of grades 3–4. A total of 529 ERCPs (96.0 %) were completed: 503 (91.3 %) using only the single-use duodenoscope, and 26 (4.7 %) with crossover to a reusable endoscope. There were 22 ERCPs (4.0 %) that were not completed, of which 11 (2.0 %) included a crossover and 11 (2.0 %) were aborted cases (no crossover). Median ERCP completion time was 24.0 minutes. Median overall satisfaction with the single-use duodenoscope was 8.0 (scale of 1 to 10 [best]). SAEs were reported in 43 patients (7.8 %), including 17 (3.1 %) who developed post-ERCP pancreatitis. Conclusions In academic medical centers over a wide geographic distribution, endoscopists with varying levels of experience using the first marketed single-use duodenoscope had good ERCP procedural success and reported high performance ratings for this device. |
format | Online Article Text |
id | pubmed-10684334 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Georg Thieme Verlag KG |
record_format | MEDLINE/PubMed |
spelling | pubmed-106843342023-11-30 Global prospective case series of ERCPs using a single-use duodenoscope Bruno, Marco J. Beyna, Torsten Carr-Locke, David Chahal, Prabhleen Costamagna, Guido Devereaux, Benedict Giovannini, Marc Goenka, Mahesh K. Khor, Christopher Lau, James May, Gary Muthusamy, V. Raman Patel, Sandeep Petersen, Bret T. Pleskow, Douglas K. Raijman, Isaac Reddy, D. Nageshwar Repici, Alessandro Ross, Andrew S. Sejpal, Divyesh V. Sherman, Stuart Siddiqui, Uzma D. Ziady, Christopher Peetermans, Joyce A. Rousseau, Matthew J. Slivka, Adam Endoscopy Background The first commercialized single-use duodenoscope was cleared by the US Food and Drug Administration in December 2019. Data regarding endoscopic retrograde cholangiopancreatography (ERCP) using a single-use duodenoscope are needed on a broader range of cases conducted by endoscopists with varying levels of experience in a wide range of geographic areas. Methods 61 endoscopists at 22 academic centers in 11 countries performed ERCP procedures in adult patients aged ≥ 18. Outcomes included ERCP completion for the intended indication, rate of crossover to a reusable endoscope, device performance ratings, and serious adverse events (SAEs). Results Among 551 patients, 236 (42.8 %) were aged > 65, 281 (51.0 %) were men, and 256 (46.5 %) had their procedure as an inpatient. ERCPs included 196 (35.6 %) with American Society for Gastrointestinal Endoscopy complexity of grades 3–4. A total of 529 ERCPs (96.0 %) were completed: 503 (91.3 %) using only the single-use duodenoscope, and 26 (4.7 %) with crossover to a reusable endoscope. There were 22 ERCPs (4.0 %) that were not completed, of which 11 (2.0 %) included a crossover and 11 (2.0 %) were aborted cases (no crossover). Median ERCP completion time was 24.0 minutes. Median overall satisfaction with the single-use duodenoscope was 8.0 (scale of 1 to 10 [best]). SAEs were reported in 43 patients (7.8 %), including 17 (3.1 %) who developed post-ERCP pancreatitis. Conclusions In academic medical centers over a wide geographic distribution, endoscopists with varying levels of experience using the first marketed single-use duodenoscope had good ERCP procedural success and reported high performance ratings for this device. Georg Thieme Verlag KG 2023-09-20 /pmc/articles/PMC10684334/ /pubmed/37463599 http://dx.doi.org/10.1055/a-2131-7180 Text en The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution License, permitting unrestricted use, distribution, and reproduction so long as the original work is properly cited. (https://creativecommons.org/licenses/by/4.0/) https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Bruno, Marco J. Beyna, Torsten Carr-Locke, David Chahal, Prabhleen Costamagna, Guido Devereaux, Benedict Giovannini, Marc Goenka, Mahesh K. Khor, Christopher Lau, James May, Gary Muthusamy, V. Raman Patel, Sandeep Petersen, Bret T. Pleskow, Douglas K. Raijman, Isaac Reddy, D. Nageshwar Repici, Alessandro Ross, Andrew S. Sejpal, Divyesh V. Sherman, Stuart Siddiqui, Uzma D. Ziady, Christopher Peetermans, Joyce A. Rousseau, Matthew J. Slivka, Adam Global prospective case series of ERCPs using a single-use duodenoscope |
title | Global prospective case series of ERCPs using a single-use duodenoscope |
title_full | Global prospective case series of ERCPs using a single-use duodenoscope |
title_fullStr | Global prospective case series of ERCPs using a single-use duodenoscope |
title_full_unstemmed | Global prospective case series of ERCPs using a single-use duodenoscope |
title_short | Global prospective case series of ERCPs using a single-use duodenoscope |
title_sort | global prospective case series of ercps using a single-use duodenoscope |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10684334/ https://www.ncbi.nlm.nih.gov/pubmed/37463599 http://dx.doi.org/10.1055/a-2131-7180 |
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