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Reusable Versus Disposable Duodenoscopes for ERCP | Clinical Trials | Clareo Health

COMPLETEDNA

Reusable Versus Disposable Duodenoscopes for ERCP

Randomized Trial Comparing Reusable and Disposable Duodenoscopes for ERCP

NCT04143698•AdventHealth

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (1)

AdventHealth Orlando

Orlando, Florida, United States

Key Dates

Start Date

January 24, 2020

Primary Completion Date

March 20, 2020

Completion Date

May 6, 2020

Last Updated

June 23, 2020

Enrollment

ACTUAL participants

Conditions

Endoscopic Retrograde Cholangiopancreatography

Interventions

endoscopic retrograde cholangiopancreatography

DEVICE

Does Pancreatic Stent Decrease the Risk of Pancreatitis After Pancreatic Sphincterotomy for Difficult Cannulation?

NCT04408482

Endoscopic Retrograde Cholangiopancreatography

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RECRUITINGNA

TEAS for Sedation During ERCP

NCT07440342

Endoscopic Retrograde CholangiopancreatographyConscious Sedation Adverse Event+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 23, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Reusable Versus Disposable Duodenoscopes for ERCP

Inclusion Criteria

Exclusion Criteria

Does Pancreatic Stent Decrease the Risk of Pancreatitis After Pancreatic Sphincterotomy for Difficult Cannulation?

TEAS for Sedation During ERCP

Effect of Deep Analgosedation vs. Endotracheal Intubation General Anesthesia on on Perioperative Sedation Related Adverse Events in Elderly ERCP Patients

Adjunct Sedatives in Endoscopic Ultrasound (EUS) and Endoscopic Retrograde Cholangiopancreatography (ERCP) Procedures

a Prediction of Post-Endoscopic Retrograde Cholangiopancreatography Complication

Propofol Patient-controlled Sedation for Endoscopic Retrograde Cholangiopancreatography