Infectious Complications and Safety Outcomes in Cholangioscopy: A Systematic Review and Meta-Analysis.

Background Single-operator cholangioscopy allows direct visualization and intervention for complex biliary disease but has been associated with higher infectious adverse events compared with standard endoscopic retrograde cholangiopancreatography. Evidence guiding antibiotic prophylaxis specific to cholangioscopy remains limited. We performed a systematic review and meta-analysis to quantify infectious complications following cholangioscopy. Methods PubMed, Embase, Scopus, Google Scholar, and the Cochrane Library were searched through March 2025. Studies reporting post-procedural bacteremia after cholangioscopy were included. Random-effects meta-analyses estimated pooled rates of bacteremia and secondary outcomes, including cholangitis, pancreatitis, technical success, clinical success, and adverse events. Sensitivity analyses and univariable meta-regression were conducted to assess heterogeneity. Publication bias was evaluated using funnel plots and Egger's test. Results Twelve studies comprising 4413 cholangioscopy procedures were included. The pooled bacteremia rate was 6.68% (95% confidence interval [CI], 1.96-20.44; I 2 = 95.5%). Pooled rates of cholangitis and pancreatitis were 4.59% (95% CI, 2.98-7.00; I 2 = 60.0%) and 3.54% (95% CI, 1.20-10.00; I 2 = 89.0%), respectively. Technical and clinical success rates were high at 97.21% and 87.13%. Sensitivity analyses demonstrated persistent heterogeneity across study design, indication, and procedure type. Meta-regression identified study design as a significant moderator, with prospective studies reporting higher bacteremia rates ( p = 0.018), explaining 43.8% of the between-study variance. Conclusions Cholangioscopy is highly effective with a low rate of severe complications. Infectious adverse events occur in 6.7% of cases. Use of routine antibiotic prophylaxis remains uncertain; targeted preprocedural prophylaxis may be considered in high-risk patients. Prospective studies are needed to standardize preventive strategies.