Reusable Versus Disposable Duodenoscopes for ERCP

June 22, 2020 updated by: AdventHealth

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

98

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Orlando, Florida, United States, 32803
        • AdventHealth Orlando

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Disposable (single-use) duodenoscope
This group will be using the disposable (single-use) duodenoscope during endoscopic retrograde cholangiopancreatography (ERCP).
Device: endoscopic retrograde cholangiopancreatography
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.
Other Names:
  • ERCP
Active Comparator: Reusable duodenoscope
This group will be using the reusable duodenoscope during endoscopic retrograde cholangiopancreatography (ERCP).
Device: endoscopic retrograde cholangiopancreatography
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.
Other Names:
  • ERCP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cannulation
Time Frame: 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.
1 day

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AdventHealth

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 24, 2020

Primary Completion (Actual)

March 20, 2020

Study Completion (Actual)

May 6, 2020

Study Registration Dates

First Submitted

June 5, 2019

First Submitted That Met QC Criteria

October 28, 2019

First Posted (Actual)

October 29, 2019

Study Record Updates

Last Update Posted (Actual)

June 23, 2020

Last Update Submitted That Met QC Criteria

June 22, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1388902

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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