Biliary Diseases, Pancreatic Duct Disorder
Conditions
Keywords
endoscopic retrograde cholangiopancreatography (ERCP), duodenoscope, single-use, reusable, biliary disorder, pancreatic duct disorder
Brief summary
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.
Detailed description
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.
Interventions
DEVICEExalt Model D
Exalt Model D single-use duodenoscope will be used in ERCP
DEVICEReusable
Standard reusable duodenoscope will be used in ERCP
Sponsors
Rush University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients \> 18 years old who have biliary or pancreatic duct disorder, based on clinical symptoms and radiological findings at CT or magnetic resonance cholangiopancreatography * Native papilla
Exclusion criteria
* Patients with altered pancreaticobiliary anatomy * Pregnancy * Patients with percutaneous transhepatic biliary drainage * Prior history of ERCP * Inability to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 and compare the total number of attempts required to achieve successful cannulation of the desired duct. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Crossover single to reusable | From the start of the ERCP to the end of procedure | The incidence of crossovers from single-use duodenoscope to reusable duodenoscope |
| Use of advanced cannulation techniques | From the start of the ERCP to the end of procedure | The utilization of advanced cannulation techniques in ERCP procedure |
| Performance on ERCP maneuvers | From the start of the ERCP to the end of procedure | 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 \[comparable with reusable duodenoscope\]) |
| Adverse events | From the completion of the ERCP to 7 days post-ERCP per standard of care | Post- ERCP pancreatitis, post-sphincterotomy bleed, and infection at 72 hours and 7 days post-ERCP procedure per Standard of Care. |
| Endoscopist-determined ease of use | From the start of the ERCP to the end of procedure | 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) |
Countries
United States
Contacts
Primary ContactNeal A Mehta, MD
Backup ContactAmanda F Lin
Outcome results
None listed