Single-use duodenoscopes for the prevention of endoscopic retrograde cholangiopancreatography -related cross-infection - from bench studies to clinical evidence.

Abstract

Background: Several strategies have been implemented to reduce or abolish the life-threatening risk of endoscopic retrograde cholangiopancreatography (ERCP)-related multidrug-resistant infections due to duodenoscopes contaminations; among those strategies, serial microbiologic tests, thorough reprocessing schedules, and use of removable scope cap have been adopted, but the potential cross-infection risk was not eliminated.

Aim: To review available evidence in the field of single-use duodenoscopes (SUD) use for ERCP.

Methods: An overview on ongoing clinical studies was also performed to delineate which data will become available in the next future.

Results: One bench comparative study and four clinical trials performed with EXALT model-D (Boston Scientific Corp., United States) have been identified. Of them, one is a randomized controlled trial, while the other three studies are prospective single-arm, cross-over studies. Pooled technical success rate (4 studies, 368 patients) was 92.9% [95% confidence interval (CI): 89.9-95.5; I ²: 11.8%]. Pooled serious adverse event (4 studies, 381 patients) rate was 5.9% [3.7%-8.5%; I ²: 0.0%].

Conclusion: Although few clinical trials are available, evidence is concordant in identifying an absolute feasibility and safety and feasibility for SUD use for ERCP. The expertise and quality of evidence in this field are going to be improved by further large clinical trials;data on cost-effectiveness and environmental impact will be needed for a worldwide spread of SUD use for ERCP.