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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exalt Model D | Experimental | Exalt Model D single use duodenoscope will be used for ERCP |
|
| Standard Reusable | Active Comparator | Standard reusable model of duodenoscope will be used for ERCP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exalt Model D | Device | Exalt Model D single-use duodenoscope will be used in ERCP |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number 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. | From the time of the ERCP to 7 days post-ERCP per standard of care |
| Measure | Description | Time Frame |
|---|---|---|
| Crossover single to reusable | The incidence of crossovers from single-use duodenoscope to reusable duodenoscope | From the start of the ERCP to the end of procedure |
| Use of advanced cannulation techniques |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Neal A Mehta, MD | Contact | 3129428651 | Neal_A_Mehta@rush.edu | |
| Amanda F Lin | Contact | 3125633907 | amanda_f_lin@rush.edu |
| Name | Affiliation | Role |
|---|---|---|
| Neal A Mehta, MD | Rush University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University Medical Center | Recruiting | Chicago | Illinois | 60607 | United States |
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| ID | Term |
|---|---|
| D005705 | Gallbladder Diseases |
| ID | Term |
|---|---|
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
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| Reusable | Device | Standard reusable duodenoscope will be used in ERCP |
|
The utilization of advanced cannulation techniques in ERCP procedure
| 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]) | 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. | 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") | From the start of the ERCP to the end of procedure |