Reusable Versus Disposable Duodenoscopes for ERCP

Not Applicable

Completed

• Conditions: Endoscopic Retrograde Cholangiopancreatography
• Interventions: Device: endoscopic retrograde cholangiopancreatography

• Registration Number: NCT04143698
• Lead Sponsor: AdventHealth

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.

Study Timeline

• Study First Submitted: 2019-06-05
• Study First Submitted QC: 2019-10-28
• Study First Posted: 2019-10-29
• Study Start: 2020-01-24
• Primary Completion: 2020-03-20
• Study Completion: 2020-05-06
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-22
• Last Update Posted: 2020-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reusable duodenoscope	endoscopic retrograde cholangiopancreatography	This group will be using the reusable duodenoscope during endoscopic retrograde cholangiopancreatography (ERCP).
Disposable (single-use) duodenoscope	endoscopic retrograde cholangiopancreatography	This group will be using the disposable (single-use) duodenoscope during endoscopic retrograde cholangiopancreatography (ERCP).

Primary Outcome Measures

Name	Time	Method
Cannulation	1 day	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.

Secondary Outcome Measures

Name	Time	Method
Total duration of the procedure	1 day	Total duration of the procedure
Rate of cross-over	1 day	Rate of cross-over to the alternate duodenoscope for completion of the procedure
Time taken for cannulation	1 day	Time taken for cannulation
Rate of adverse events	7 days and 30 days	Assessment of AEs and SAEs
Rate of use of advanced cannulation techniques	1 day	Need for use of advanced cannulation techniques
Ease of passage of duodenoscope and imaging and mechanical function of the duodenoscope	1 day	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.
Ease of completion of interventions	1 day	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.

Trial Locations

Locations (1)

AdventHealth Orlando; 🇺🇸 Orlando, Florida, United States