Single-use duodenoscopes achieved 100% cannulation success in 28 pediatric ERCP cases with a 14% complication rate.
This retrospective cohort study examined the initial experience of using EXALT Model D single-use duodenoscopes for endoscopic retrograde cholangiopancreatography (ERCP) in a pediatric population. The study included 28 patients undergoing the procedure at a single quaternary care center. The primary focus was on technical success and safety, with no comparator group included to assess relative performance against reusable devices.
Technical outcomes were favorable across the cohort. Biliary cannulation was successful in all 28 cases. Procedure complexity, assessed by ASGE grade, was grade 1 or 2 in the majority of patients. Stone extraction was performed in 27 cases, stent removal in 25 cases, and new stent placement in 3 cases.
Safety analysis identified adverse events in 4 patients, including abdominal pain (n=2), post-ERCP pancreatitis (n=1), and cholangitis (n=1). No serious adverse events were reported, and no procedures required conversion to reusable duodenoscopes. However, the study did not report long-term follow-up data or cost-benefit analysis.
Key limitations include the single-center retrospective design, small sample size, and lack of a control group. Data were limited for younger/smaller patients and higher ASGE grades (3 and 4). As an observational study, these results describe associations rather than causation. While single-use duodenoscopes may offer a promising alternative for reducing infection risk and simplifying maintenance, superiority cannot be established, and generalizability to complex procedures remains uncertain.
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