Adam Slivka1, Andrew S Ross2, Divyesh V Sejpal3, Bret T Petersen4, Marco J Bruno5, Douglas K Pleskow6, V Raman Muthusamy7, Jennifer S Chennat1, Rajesh Krishnamoorthi2, Calvin Lee3, John A Martin4, Jan-Werner Poley5, Jonah M Cohen8, Adarsh M Thaker7, Joyce A Peetermans9, Matthew J Rousseau9, Gregory P Tirrell9, Richard A Kozarek2. 1. Department of Gastroenterology, Hepatology, and Nutrition, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA. 2. Department of Gastroenterology, Digestive Disease Institute, Virginia Mason Medical Center, Seattle, Washington, USA. 3. Division of Gastroenterology, Zucker School of Medicine at Hofstra/Northwell, North Shore University Hospital, Manhasset, New York, USA. 4. Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA. 5. Department of Gastroenterology and Hepatology, Erasmus Medical Center, University Medical Center, Rotterdam, The Netherlands. 6. Center for Advanced Endoscopy, Division of Gastroenterology, Beth Israel Deaconess Medical Center, and Harvard Medical School, Boston, Massachusetts, USA. 7. Vatche and Tamar Manoukian Division of Digestive Diseases, University of California, Los Angeles and David Geffen School of Medicine at UCLA, Los Angeles, California, USA. 8. Division of Gastroenterology, Massachusetts General Hospital, and Harvard Medical School, Boston, Massachusetts, USA. 9. Endoscopy Division, Boston Scientific Corporation, Marlborough, Massachusetts, USA.
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.).
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.).
Authors: Diederik Persyn; Hannah Van Malenstein; Emma Vanderschueren; Annette Schuermans; Mira Dreesen; Wouter Meert; Kristof Buysschaert; Schalk Van Der Merwe; Wim Laleman Journal: Ann Gastroenterol Date: 2022-06-02