Article Text
Abstract
Background Traditional reusable duodenoscopes (RD) used in endoscopic retrograde cholangiopancreatography (ERCP) procedures pose a significant risk of infection transmission. Single-use duodenoscopes (SUD) have emerged as a potential alternative to mitigate this risk. This systematic review and meta-analysis aim to compare the technical success and safety of SUD with RD.
Methods A comprehensive search was conducted in PubMed, CINAHL, and Embase databases to identify relevant studies on ERCP performed using SUD. English full-text journal articles published within the last 10 years were included. The PRISMA guidelines were followed. The primary outcome assessed was the successful cannulation rate using SUD, while the secondary outcome measured the adverse events rate within 30 days post-ERCP using SUD. The risk of bias for both non-randomised and randomised studies was assessed using the ROBINS-I and ROB-2 tools, respectively. Meta-analysis was performed using the overall proportion from all included studies, and heterogeneity among the studies was assessed using τ2 and ι2 statistics. Statistical analysis was conducted using RStudio 2023.12.1. This systematic review has been registered in PROSPERO.
Results 117 studies were identified from various online databases and 9 of them were eligible for inclusion. Overall, 1,273 patients were included in the meta-analysis. The primary outcome, successful cannulation rate, revealed a pooled yield of up to 92.00% (95% CI: 90.00–93.00) for SUD. The secondary outcome, adverse events rate within 30 days post-ERCP, was found to be 9% (95% CI: 6–12, p<0.01) with SUD. These outcomes were found to be comparable to those reported in the literature for RD.
Conclusions This systematic review and meta-analysis provide evidence supporting the effectiveness and safety of SUD as an alternative to RD in ERCP procedures. The results indicate that SUD achieves comparable technical success and safety profiles. Further randomised controlled trials are recommended to provide a higher level of evidence to demonstrate the non-inferiority of SUD compared to RD in terms of technical success and safety profiles in ERCP procedures.