Reusable Versus Disposable Duodenoscopes for ERCP

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Randomized Trial Comparing Reusable and Disposable Duodenoscopes for ERCP

Conditions
-----------------
Endoscopic Retrograde Cholangiopancreatography

Intervention / Treatment
-----------------
* Device: endoscopic retrograde cholangiopancreatography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years old Patients with native papilla 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: Age <18 years old Unable to obtain informed consent Pregnancy Altered upper gastrointestinal surgical anatomy Patients with percutaneous transhepatic biliary drainage catheters Prior history of ERCP

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Disposable (single-use) duodenoscope<br>This group will be using the disposable (single-use) duodenoscope during endoscopic retrograde cholangiopancreatography (ERCP). | Device: endoscopic retrograde cholangiopancreatography<br>* The duodenoscope will be passed to the duodenum in the standard fashion. Once the papilla has been identified in the duodenum, cannulation of the desired duct will be performed in the standard fashion, with the type of accessories used left to the discretion of the individual endoscopist performing the procedure. If cannulation is considered difficult, advanced cannulation techniques can be used per standard of care at the discretion of the individual endoscopist. The types of accessories used will be left to the discretion of the individual endoscopist and will be dependent on procedure indication and personal preference. Cross-over to the alternate duodenoscope type can be performed at any time if the desired technical maneuver cannot be performed with the designated duodenoscope.<br>* Other names: ERCP;|
| Active Comparator: Reusable duodenoscope<br>This group will be using the reusable duodenoscope during endoscopic retrograde cholangiopancreatography (ERCP). | Device: endoscopic retrograde cholangiopancreatography<br>* The duodenoscope will be passed to the duodenum in the standard fashion. Once the papilla has been identified in the duodenum, cannulation of the desired duct will be performed in the standard fashion, with the type of accessories used left to the discretion of the individual endoscopist performing the procedure. If cannulation is considered difficult, advanced cannulation techniques can be used per standard of care at the discretion of the individual endoscopist. The types of accessories used will be left to the discretion of the individual endoscopist and will be dependent on procedure indication and personal preference. Cross-over to the alternate duodenoscope type can be performed at any time if the desired technical maneuver cannot be performed with the designated duodenoscope.<br>* Other names: ERCP;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cannulation | The ease of cannulation of the desired duct (biliary or pancreatic), as measured by the total number of cannulation attempts to achieve successful cannulation of the desired duct. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ease of passage of duodenoscope and imaging and mechanical function of the duodenoscope | Ease of maneuverability of the duodenoscope to reach the major papilla, the imaging and mechanical function of the duodenoscope, measured on a five point scale with 1 being the easiest and 5 being the most difficult. | 1 day | 
| Ease of completion of interventions | Ease of completion of each step of the ERCP procedure, measured on a 5 point scale with 1 being the easiest and 5 being the most difficult. | 1 day | 
| Rate of use of advanced cannulation techniques | Need for use of advanced cannulation techniques | 1 day | 
| Rate of cross-over | Rate of cross-over to the alternate duodenoscope for completion of the procedure | 1 day | 
| Time taken for cannulation | Time taken for cannulation | 1 day | 
| Total duration of the procedure | Total duration of the procedure | 1 day | 
| Rate of adverse events | Assessment of AEs and SAEs | 7 days and 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
duodenoscopes; ERCP