Randomized Trial Supports the Use of Disposable Elevator Caps During ERCP To Reduce Persistent Microbial Infection Rates

There has been significant concern, including from the U.S. Food and Drug Administration, regarding the increased rate of infectious outbreaks related to duodenoscopes. Novel device classes, including single-use duodenoscopes with disposable caps (with a traditional elevator still part of the scope) and disposable elevator caps (DECs), have been developed to address this issue.

This randomized controlled trial evaluated DEC duodenoscopes compared to standard duodenoscopes (with removable nondisposable caps) in terms of persistent microbial contamination and technical performance. The study included 518 adults (49.8% female) undergoing endoscopic retrograde cholangiopancreatography (ERCP) for any indication. The patients had a mean age of 60.7 years and a mean Charlson Comorbidity Index of 3.0. Most of the ERCP procedures (92.1%) were of ASGE Grade II or III difficulty.

The ERCP procedures performed with DECs resulted in persistent microbial contamination (defined as ≥10 colony-forming units of any organism or any growth of gram-negative bacteria) following 2 cycles of high-level disinfection in 3.8% of cases versus 11.2% with standard duodenoscopes (P=.004). This corresponded to a number needed to treat of 13.6 (95% confidence interval, 8.1-42.7) to avoid an occurrence of persistent contamination. Interestingly, the most common site of persistent contamination was the instrument channel, not the elevator. Technical success, defined using dual-blinded outcome assessors according to a priori criteria, was noninferior with DECs compared with standard duodenoscopes (94.6% vs 90.7%; P=.13). Safety outcomes and adverse events were similar between groups.