Reusable Versus Disposable Duodenoscopes for ERCP

Randomized Trial Comparing Reusable and Disposable Duodenoscopes for ERCP

The aim of this randomized trial is to evaluate the technical aspects of disposable duodenoscopes and to compare the technical outcomes between the disposable (single-use) and reusable duodenoscopes.

Given the recent reports on infection outbreaks, including carbapenem-resistant Enterobacteriaceae (CRE), caused by contaminated duodenoscopes used at endoscopic retrograde cholangiopancreatography (ERCP), a disposable (single-use) duodenoscope (Exalt, Single-Use Duodenoscope, Boston Scientific Corporation, Natick, MA) has been developed to circumvent this issue. However, there are currently no data on the technical features and outcomes of disposable duodenoscopes, in comparison with reusable duodenoscopes.

The aim of this randomized trial is therefore to evaluate the technical aspects of disposable duodenoscopes and to compare the technical outcomes between the two duodenoscope types.

Inclusion Criteria:

1. Age ≥ 18 years old
2. Patients with native papilla
3. Requiring an ERCP procedure for biliary or pancreatic duct disorder, based on clinical symptoms and radiological findings at computed tomography or magnetic resonance cholangiopancreatography

Exclusion Criteria:

1. Age <18 years old
2. Unable to obtain informed consent
3. Pregnancy
4. Altered upper gastrointestinal surgical anatomy
5. Patients with percutaneous transhepatic biliary drainage catheters
6. Prior history of ERCP