| Source: |
Bruno, MJ, Beyna, T, EXALT Single-use Duodenoscope Study Group, Carr-Locke, D, Chahal, P, Costamagna, G, Devereaux, B, Giovannini, M, Goenka, MK, Khor, C, Lau, J, May, G, Muthusamy, VR, Patel, S, Petersen, BT, Pleskow, DK, Raijman, I, Reddy, DN, Repici, A, Ross, AS, Sejpal, DV, Sherman, S, Siddiqui, UD, Ziady, C, Peetermans, JA, Rousseau, MJ & Slivka, A 2023, 'Global prospective case series of ERCPs using a single-use duodenoscope', Endoscopy, vol. 55, no. 12, pp. 1103-1114. https://doi.org/10.1055/a-2131-7180 |
| 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. |