Published online May 20, 2022. doi: 10.5662/wjm.v12.i3.122
Peer-review started: November 28, 2021
First decision: January 12, 2022
Revised: January 16, 2022
Accepted: March 16, 2022
Article in press: March 16, 2022
Published online: May 20, 2022
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.
To review available evidence in the field of single-use duodenoscopes (SUD) use for ERCP.
An overview on ongoing clinical studies was also performed to delineate which data will become available in the next future.
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%].
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.
Core Tip: Endoscopic retrograde cholangiopancreatography (ERCP) has significantly changed the management and natural history of patients with biliary and pancreatic diseases. While in the past decades ERCP procedure were considered safe and bearing low-risk for exogenous pathogens transmission, the risk of duodenoscopes contaminations and related cross-infection was recently demonstrated and quantified. To overcome this issue, two different single-use duodenoscopes (SUD) have been developed and are commercially available. The sterile packaging and the disposable intent guarantee to avoid exogenous patient-to-patient cross-infections. A systematic review of all available clinical evidence on the use of SUD for ERCP was performed, demonstrating an overall pooled safety and efficacy. 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. Future large clinical trials are ongoing to increase the knowledge and quality of evidence in the field; data on cost-effectiveness and environmental impact will be needed for a worldwide spread of SUD use for ERCP.