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

ARTICLE HIGHLIGHTS

Research background

Single-use duodenoscope use has been proposed as an effective strategy to avoid the risk of duodenoscope-related cross-infections in patients undergoing endoscopic retrograde cholangiopancreatography (ERCP).

Research motivation

Recentaly, several manuscript have been published reporting the ouctomes of clinical studies on single-use duodenoscope use for ERCP.

Research objectives

To perform a systematic review of the literature and report qualitative and quantitative results in terms of technical success rate, clinical success, and safety.

Research methods

Systematic review and quantitative analysis.

Research results

Five original articles have been identified. 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; I²: 11.8%]. Pooled serious adverse event (4 studies, 381 patients) rate was 5.9% [3.7%-8.5%; I²: 0.0%].

Research conclusions

Although few clinical trials are available, evidence is concordant in identifying an absolute feasibility and safety and feasibility for single-use duodenoscopes (SUD) use for ERCP. Data on cost-effectiveness and environmental impact will be needed for a worldwide spread of SUD use for ERCP.

Research perspectives

Future perspective and study pipelines should assess the use of other models of single-use duodenoscope, cost-effectiveness of single-use duodenoscope use for ERCP and environmental sustainability.