Comparison of Duodenoscope With Single-use Distal Cover and the Conventional Reusable Duodenoscope

Study Overview
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Brief Summary
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The purpose of the study is to compare the success rates of procedure success and complication rates in patients undergoing Endoscopic retrograde cholangiopancreatography (ERCP) using two types of currently available endoscopes. These are (1) duodenoscope with a Single-use distal cover or (2) a conventional reusable duodenoscope.

Detailed Description
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The risks associated with the ERCP procedure will be explained to patients who meets the eligibility criteria. Consenting patients will be randomized to undergo Endoscopic retrograde cholangiopancreatography (ERCP) using either (1) a duodenoscope with a Single-use distal cover or (2) a conventional reusable duodenoscope. Assessments will be made during, and immediately after the procedure, then patients will be called after 1 week, 1 month, and 3 months after the procedure to get information about adverse events.

Official Title
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Comparison of Outcomes in Patients Undergoing Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) Using Duodenoscope With Single-use Distal Cover and Conventional Reusable Duodenoscope: A Randomized Controlled Trial

Conditions
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Biliary Disease, Pancreatic Disease, Choledocholithiasis, Biliary Obstruction, Biliary Tract Neoplasms, Pancreatic Neoplasms

Intervention / Treatment
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* Device: Duodenoscope with single-use distal cover
* Device: Conventional duodenoscope


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing ERCP for biliary and pancreatic conditions Age > 18 years old Exclusion Criteria: Vulnerable patient groups including pregnant women Patients who are unable to consent Patients with known cholangitis Patients with known Carbapenem-Resistant Enterobacteriaceae (CRE) or any other multi-drug resistant organisms (MDRO) infection Surgically altered anatomy except for Billroth I

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Duodenoscope with single-use distal cover<br>Patients will undergo ERCP using a duodenoscope with a single-use distal cover | Device: Duodenoscope with single-use distal cover<br>* Newer duodenoscope with a single-use distal cover<br>|
| Active Comparator: Conventional Duodenoscope<br>Patients will undergo ERCP using a conventional duodenoscope | Device: Conventional duodenoscope<br>* Conventional duodenoscope with standard methods of reprocessing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with procedure-related adverse events | Patients undergoing Endoscopic retrograde cholangiopancreatography (ERCP) using either of the 2 duodenoscopes will be assessed for superficial mucosal injury, perforation of the stomach or intestine, mucosal bleeding, pancreatitis, infection, death or any other symptom reported by the patient. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duodenoscope maneuverability | Patients undergoing Endoscopic retrograde cholangiopancreatography (ERCP) using either of the 2 duodenoscopes will be assessed for its maneuverability during the procedure using a previously defined scoring system which uses a 5-point scale ranging from 1 to 5, with 1 being easy to perform, 2 minimal difficulty, 3 moderate difficulty, 4 severe difficulty and 5 unable to complete the requisite maneuver(1). | Maneuverability will be assessed only during the procedure (approximately 10 minutes) | 
| Duodenoscope mechanical characteristics profile | Patients undergoing Endoscopic retrograde cholangiopancreatography (ERCP) using either of the 2 duodenoscopes will be assessed for their mechanical characteristics (scope stiffness, air-water button functionality, elevator efficiency and hand strain). Each characteristic will be assessed using a published 5-point scoring system. | Mechanical and imaging characteristics will be assessed only during the procedure (approximately 15 minutes) | 
| Duodenoscope imaging characteristics profile | Patients undergoing Endoscopic retrograde cholangiopancreatography (ERCP) using either of the 2 duodenoscopes will be assessed for their imaging characteristics (image quality and stability). Each characteristic will be assessed using a published 5-point scoring system. | Mechanical and imaging characteristics will be assessed only during the procedure (approximately 15 minutes) | 
| Ability to perform interventions | Patients undergoing Endoscopic retrograde cholangiopancreatography (ERCP) using either of the 2 duodenoscopes will be assessed for their ability to perform endoscopic maneuvers like sphincterotomy, balloon sweep, use of basket/mechanical lithotriptor, stone clearance, stricture dilation using balloon/catheter, stent insertion, stent removal and use of single operator cholangioscopy/pancreatoscopy. Each patient's procedure will be assessed on a 5-point scale ranging from 1 to 5, with 1 being easy to perform, 2 minimal difficulty, 3 moderate difficulty, 4 severe difficulty and 5 unable to complete the requisite maneuver. | 30-60 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ERCP, Duodenoscope, Duodenoscope with single-use distal cover