Citations 2
Global prospective case series of ERCPs using a single-use duodenoscope
Bruno, Marco J. , Beyna, Torsten , Carr‐Locke, David L. , Chahal, Prabhleen , Costamagna, Guido , Devereaux, Benedict , Giovannini, Marc, Khor, Christopher , Lau, James Y., May, Gary R. , Muthusamy, V. Raman , Petersen, Bret T. , Raijman, Isaac , Reddy, D. Nageshwar , Ross, Andrew S., Sejpal, Divyesh V., Sherman, Stuart , Siddiqui, Uzma D. , Ziady, Christopher, Peetermans, Joyce , Rousseau, Matthew , Slivka, Adam, Group, EXALT Single-use Duodenoscope Study, Fichera, Alessandro , Pleskow, Douglas , Goenka, Mahesh Kumar , Patel, Sandeep , Petersen, Bret T. , Pleskow, Douglas K. , Repici, Alessandro , Group, EXALT Single-use Duodenoscope Study
Endoscopy | July 18, 2023 | Volume: 55 | Issue: 12 | Pages: 1103-1114
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.
International consensus statements for endoscopic management of distal biliary stricture
Nakai, Yousuke , Rerknimitr, Rungsun , Khor, Christopher , Yasuda, Ichiro , Lau, James Y. , Lakhtakia, Sundeep , Ratanachu‐ek, Thawee , Lee, Dong Ki , Makmun, Dadang , Dy, Frederick, Draganov, Peter V. , Almadi, Majid A. , Ryozawa, Shomei , Wallace, Michael B. , Itoi, Takao , Devereaux, Benedict , Aniwan, Satimai , Makmun, Dadang , Rerknimitr, Rungsun , Yasuda, Ichiro , Lau, James , Lakhtakia, Sundeep , Kitano, Masayuki , Devereaux, Benedict , Wallace, Michael B , Isayama, Hiroyuki , Wang, Hsiu‐Po , Kogure, Hirofumi , Moon, Jong Ho , Seo, Dong Wan , Liao, Wei‐Chih , Irisawa, Atsushi , Katanuma, Akio , Fujisawa, Toshio
Journal of Gastroenterology and Hepatology | December 5, 2019 | Volume: 35 | Issue: 6 | Pages: 967-979
AbstractDistal biliary strictures (DBS) are common and may be caused by both malignant and benign pathologies. While endoscopic procedures play a major role in their management, a comprehensive review of the subject is still lacking. Our consensus statements were formulated by a group of expert Asian pancreatico‐biliary interventional endoscopists, following a proposal from the Digestive Endoscopy Society of Taiwan, the Thai Association for Gastrointestinal Endoscopy, and the Tokyo Conference of Asian Pancreato‐biliary Interventional Endoscopy. Based on a literature review utilizing Medline, Cochrane library, and Embase databases, a total of 19 consensus statements on DBS were made on diagnosis, endoscopic drainage, benign biliary stricture, malignant biliary stricture, and management of recurrent biliary obstruction and other complications. Our consensus statements provide comprehensive guidance for the endoscopic management of DBS.