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Reusable Versus Disposable Duodenoscopes for ERCP

Sponsor
AdventHealth (Other)
Overall Status
Completed
CT.gov ID
NCT04143698
Collaborator
(none)
98
Enrollment
1
Location
2
Arms
3.4
Actual Duration (Months)
29
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: endoscopic retrograde cholangiopancreatography
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
98 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Randomized Trial Comparing Reusable and Disposable Duodenoscopes for ERCP
Actual Study Start Date :
Jan 24, 2020
Actual Primary Completion Date :
Mar 20, 2020
Actual Study Completion Date :
May 6, 2020

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    2. 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.

    3. Rate of use of advanced cannulation techniques [1 day]

      Need for use of advanced cannulation techniques

    4. Rate of cross-over [1 day]

      Rate of cross-over to the alternate duodenoscope for completion of the procedure

    5. Time taken for cannulation [1 day]

      Time taken for cannulation

    6. Total duration of the procedure [1 day]

      Total duration of the procedure

    7. Rate of adverse events [7 days and 30 days]

      Assessment of AEs and SAEs

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 AdventHealth Orlando Orlando Florida United States 32803

    Sponsors and Collaborators

    • AdventHealth

    Investigators

    • Principal Investigator: Shyam Varadarajulu, MD, AdventHealth Orlando

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    AdventHealth
    ClinicalTrials.gov Identifier:
    NCT04143698
    Other Study ID Numbers:
    • 1388902
    First Posted:
    Oct 29, 2019
    Last Update Posted:
    Jun 23, 2020
    Last Verified:
    Jun 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by AdventHealth
    duodenoscopes; ERCP

    Study Results

    No Results Posted as of Jun 23, 2020