This randomized controlled trial (RCT) is designed to evaluate the new generation Exalt Model disposable duodenoscope compared to the reusable scope in terms of feasibility, ease of use, adverse events, number of crossover events, and infection rates.
To ensure a safe and high-quality endoscopy, there are multiple disinfection protocols for endoscopes. Side-viewing duodenoscopes with an adjustable accessory device (elevator) contain potential blind spots for debris and bacteria that require specialized cleaning and disinfection methods beyond standard protocols for other endoscopes. It is thought that the duodenoscope's design, persistent postprocedural microbial contamination and biofilm formation make it more prone to cross-contamination5. Gromski et al, found there are documented pathogenic transmissions, which led to harm in multiple patients and centers3. Infection control was likely related to two major components, reusable duodenoscopes and procedural factors related to how the reusable duodenoscopes were reprocessed3. Multidrug-resistant organisms, such as carbapenem-resistant Enterobacteriaceae, that were associated with reusable duodenoscopes lead the FDA to mandate the transition to improved cleaning and disinfection methods or single-use platforms to eliminate infection transmission. One such single-use platform is the Exalt Model D (Boston Scientific, Marlboro, MA), which received FDA approval in 2020 for use of single-use duodenoscopes. Early iterations of the Exalt were used on a case-by-case basis per institution-specific protocols, mainly due to the learning curve involved with using the scope. A new version of Exalt has been released to market in 2023 with modifications that may make it more feasible to use in all settings requiring a duodenoscope. This randomized controlled trial (RCT) is designed to evaluate the new generation Exalt Model disposable duodenoscope compared to the reusable scope in terms of feasibility, ease of use, adverse events, number of crossover events, and infection rates.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
100
Exalt Model D single-use duodenoscope will be used in ERCP
Standard reusable duodenoscope will be used in ERCP
Rush University Medical Center
Chicago, Illinois, United States
RECRUITINGNumber of attempts required to achieve successful cannulation of the desired duct
Measure and compare the total number of attempts required to achieve successful cannulation of the desired duct.
Time frame: From the time of the ERCP to 7 days post-ERCP per standard of care
Crossover single to reusable
The incidence of crossovers from single-use duodenoscope to reusable duodenoscope
Time frame: From the start of the ERCP to the end of procedure
Use of advanced cannulation techniques
The utilization of advanced cannulation techniques in ERCP procedure
Time frame: From the start of the ERCP to the end of procedure
Performance on ERCP maneuvers
Subjective ratings on 14 ERCP maneuvers. ("not preferred/neutral/preferred" relative to the reusable duodenoscope endoscopist usually uses in clinical practice), 23 device performance characteristics. (Likert scale of 1 \[not preferred\] to 5 \[comparable with reusable duodenoscope\])
Time frame: From the start of the ERCP to the end of procedure
Adverse events
Post- ERCP pancreatitis, post-sphincterotomy bleed, and infection at 72 hours and 7 days post-ERCP procedure per Standard of Care.
Time frame: From the completion of the ERCP to 7 days post-ERCP per standard of care
Endoscopist-determined ease of use
Median overall satisfaction with the single-use duodenoscope during the procedure (Likert scale of 1 \[unsatisfied\] to 10 \[very satisfied\], followed by the option "If you answered ≤ 5, specify reason")
Time frame: From the start of the ERCP to the end of procedure
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