Abstract
BACKGROUND: Single-use duodenoscopes (SDs) were introduced to eliminate exogenous infection risks post-endoscopic retrograde cholangiopancreatography (ERCP). AIM: To evaluate their efficacy and safety against reusable duodenoscopes (RDs). METHODS: This was a single-center case control study. All consecutive patients undergoing ERCP using SD between 2020 and 2023 were enrolled. A similar number of patients undergoing ERCP using RD were randomly selected and enrolled. In case of ERCP failure using SD, operators switched to a RD if judged appropriate. The primary outcome was successful ERCP completion rates. The secondary outcomes were rate of difficult biliary cannulation, incidence of crossover from SD to RD, procedure related adverse events, 30-day re-admission rate, and endoscopists' assessment of SD's performance. RESULTS: A total of 133 patients were enrolled (n = 53 for SD, n = 80 for RD). Baseline characteristics and American Society for Gastrointestinal Endoscopy ERCP complexity grades were comparable between both groups. Successful ERCP completion rates were 88.7% for SD and 95% for RD (P = 0.3). In cases of unsuccessful ERCP with SD, crossover to RD occurred in 3 out of 6 instances, with 2 subsequently succeeding with RD. Rates of adverse events and 30-day readmission were comparable: (1) 13.2% vs 11.2% (P = 0.19); and (2) 15.4% vs 8.9% (P = 0.25), respectively. Median overall endoscopists' satisfaction with SD was 8 out of 10. CONCLUSION: The novel SDs demonstrated no difference in efficacy and safety compared to conventional RDs when used to perform a wide range of ERCPs. Nevertheless, further development and study of SDs' financial and environmental effectiveness is warranted.