Performance of single-use duodenoscopes for ERCP: a systematic review and meta-analysis

Transmission of exogenous pathogens during ERCP because of contaminated duodenoscopes has been an emerging problem worldwide. Single-use duodenoscopes (SUDs) have been proposed as a viable alternative to mitigate this risk. We performed a systematic review and meta-analysis evaluating the performance characteristics, safety profile, and overall endoscopist satisfaction with the use of SUDs for ERCP.

Electronic databases from 2014 through September 2022 were searched for publications addressing performance characteristics, safety profile, and overall endoscopist impression of SUDs for ERCPs. Pooled proportions were calculated using both fixed- and random-effects models.

Five studies comprising 420 patients were included. In these patients, 43.00% (95% confidence interval [CI], 38.32-47.75) had previous biliary or pancreatic sphincterotomy. In the pooled analysis, the ERCP completion rate with SUDs was 92.32% (95% CI, 89.60-94.67). The pooled crossover rate from SUDs to reusable duodenoscopes was 7.45% (95% CI, 5.15-10.15). After crossover, 61.85% (95% CI, 44.78-77.53) of the failed ERCPs were completed using a conventional duodenoscope. The pooled overall completion rate was 96.25% (95% CI, 93.61-98.21). The pooled estimate of endoscopist satisfaction score with SUDs was 8.32 (95% CI, 7.46-9.18) on a Likert scale of 1 to 10. Individual ERCP maneuvers were also rated on a Likert scale of 1 to 5. Overall, 29.88% of procedures (95% CI, 25.62-34.33) were grade 3 and 9.37% (95% CI, 6.78-12.34) were grade 4 according to the American Society for Gastrointestinal Endoscopy grade for complexity. Adverse event rates were calculated.

Our analysis showed that SUDs deliver consistent performance across a wide range of ERCP procedures with an excellent safety profile. Although SUDs are an exciting alternative to reduce the risk of exogenous duodenoscope-related infections, further robust research is needed to clarify the most appropriate indications for their use.