Disposable elevator cap duodenoscopes outperform standard design in contamination rate
Disposable elevator cap duodenoscopes decreased the risk for persistent microbial contamination while maintaining technical performance in endoscopic retrograde cholangiopancreatography, according to data in JAMA Internal Medicine.
“Several novel duodenoscope designs have emerged, including entirely disposable duodenoscopes, whose high costs and suboptimal technical performance collectively limit widespread adoption in their current form,” Nauzer Forbes, MD, MSc, advanced and therapeutic endoscopy specialist at the University of Calgary, and colleagues wrote. “In contrast, duodenoscopes with disposable elevator caps have been developed and represent a promising potential solution.
“However, the potential for reduced contamination of these novel duodenoscopes remains unproven, and their clinical performance has only been assessed in an unblinded case series.”
In a parallel-arm, multicenter, randomized clinical trial, Forbes and colleagues compared contamination rates and technical performance of duodenoscopes with disposable elevator caps vs. standard designs.
They included 518 patients who underwent endoscopic retrograde cholangiopancreatography (ERCP), who were randomized to disposable elevator cap duodenoscope (n = 259) and standard duodenoscope (n = 259) groups between December 2019 and February 2022. For the microbiology analysis, researchers included 208 patients in the disposable group and 214 in the standard group and sampled their duodenoscopes after high-level disinfection.
Researchers detected persistent microbial contamination among 11.2% of duodenoscopes in the standard group and 3.8% in the disposable group, which corresponded to a relative risk of 0.34 (95% CI, 0.16-0.75). At 30-day follow-up, the number needed to treat was 13.6 (95% CI, 8.1-42.7) to avoid persistent contamination,
Researchers further reported similar technical success between the disposable group (94.6%) and standard group (90.7%) with no differences in adverse events.
Financial analysis also showed the disposable caps reduced persistent microbial contamination at an incremental cost of approximately $50 or 3% to 7% of overall procedure cost.
“In this randomized clinical trial, we demonstrated that disposable elevator cap duodenoscopes exhibited lower persistent microbial contamination rates following high-level disinfection compared with standard duodenoscopes while maintaining a noninferior technical performance of ERCP and similar safety outcomes,” Forbes and colleagues concluded.
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