Exalt Single-use Duodenoscope Vs Reusable Scope, a Randomized Controlled Trial
Rush University Medical Center
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.
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 pa…
Eligibility
- Age range
- 19+ years
- Sex
- All
- 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
Interventions
- DeviceExalt Model D
Exalt Model D single-use duodenoscope will be used in ERCP
- DeviceReusable
Standard reusable duodenoscope will be used in ERCP
Location
- Rush University Medical CenterChicago, Illinois