Rousseau, Matthew

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.

INTRODUCTION: Exogenous transmission of infection via duodenoscope cross-contamination after failed disinfection is a preventable risk. Inadequate reprocessing of reusable duodenoscopes can occur. Given this possibility, a new single-use duodenoscope was recently developed. It had comparable performance to reusable duodenoscopes when tested by expert endoscopists in a comparative bench model for endoscopic retrograde cholangiopancreatography (ERCP). We subsequently aimed to assess the performance of this disposable duodenoscope in a series of human cases. METHODS: Six academic medical centers enrolled consecutive adults 18 years or older without altered pancreaticobiliary anatomy scheduled for an ERCP. Seven ERCP experts rated the new EXALT single-use Model D duodenoscope (Boston Scientific, Marlborough, MA; ClinicalTrials.gov NCT03701958) in ERCP procedures for Overall Satisfaction on a scale of 1 (unsatisfied) to 10 (very satisfied), “Not preferred/Neutral/Preferred” compared to reusable duodenoscopes on 23 ERCP maneuvers, and Qualitative Comparison of 17 performance characteristics on a scale of 1 (not preferred) to 5 (comparable to reusable duodenoscopes). RESULTS: Sixty consecutive patients had an ERCP using the first-generation single-use duodenoscope in April and May 2019. Thirty-seven (61.7%) were male, mean age was 64.4 years, and 44 (73.3%) had a prior ERCP at baseline. All 60 ERCP procedures were successfully performed, 58 (96.7%) with the single-use duodenoscope alone and 2 (3.3%) with crossover to a reusable duodenoscope. Median overall satisfaction with the single-use duodenoscope was rated 9.0 (range 1-10). The overall satisfaction rating was ≥ 7 in 56 (93.3%) ERCPs. All three ratings were at or above midpoint (Overall satisfaction ≥ 5, Comparative ERCP maneuver “Neutral/Preferred,” Qualitative Comparative rating of performance characteristic 3-5) in 47 (78.3%) cases. Four ERCPs had low (≤4) overall satisfaction ratings attributed to inadequate pushability of instruments due to suboptimal positioning of the duodenoscope in front of the papilla; these ERCPs were a subset in which biliary or pancreatic duct strictures were dilated and/or stented. CONCLUSION: Expert endoscopists reported good overall performance of a new single-use duodenoscope in a broad array of cases. Low ratings occurred rarely and were associated with particular ERCP maneuvers. Detailed design improvements to the single-use duodenoscope are underway.