Clinical impact of disposable elevator-cap duodenoscopes on post-ERCP cholangitis: a prospective cohort study.

BACKGROUND AND AIMS: Disposable elevator-cap (DEC) duodenoscopes were developed to reduce residual microbial contamination after reprocessing and potentially lower infection transmission. We compared clinical outcomes of DEC-equipped and conventional duodenoscopes in routine practice, focusing on post-endoscopic retrograde cholangiopancreatography (ERCP) cholangitis and multidrug-resistant (MDR) pathogen-associated cholangitis. METHODS: This prospective, single-center observational cohort study included consecutive adults undergoing ERCP with either DEC-equipped or conventional duodenoscopes. The primary outcome was MDR pathogen-associated post-ERCP cholangitis within 7 days. Secondary outcomes included overall post-ERCP cholangitis, ERCP-related adverse events, technical success, and procedure time. Baseline imbalances were adjusted using 1:1 propensity score matching. A prespecified analysis was performed after enrollment of approximately 1,000 patients to evaluate study progress. Results of routine post-high-level disinfection microbiologic surveillance cultures were descriptively reviewed. RESULTS: Among 1,039 patients (318 DEC-equipped, 721 conventional), MDR pathogen-associated post-ERCP cholangitis occurred in 8 (2.5%) and 18 (2.5%) patients in the DEC and conventional groups, respectively, with no significant difference between groups. After propensity score matching, the incidence remained identical, and duodenoscope type was not associated with the primary outcome. Technical success, overall adverse events, and procedure time were comparable between groups after matching. Surveillance cultures detected microbial contamination exclusively in conventional duodenoscopes, whereas no microbial growth was identified in DEC-equipped duodenoscopes. Based on a prespecified analysis suggesting a low likelihood of detecting a clinically meaningful difference, the study was not further extended. CONCLUSIONS: DEC-equipped duodenoscopes did not reduce MDR pathogen-associated or overall post-ERCP cholangitis compared with conventional duodenoscopes, although no microbial growth was detected in DEC-equipped duodenoscopes on surveillance cultures. Further studies are needed to determine whether this microbiologic difference translates into clinically meaningful benefits in selected high-risk populations.