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Reusable Versus Disposable Duodenoscopes for ERCP

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ClinicalTrials.gov Identifier: NCT04143698
Recruitment Status : Completed
First Posted : October 29, 2019
Last Update Posted : June 23, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Endoscopic Retrograde Cholangiopancreatography Device: endoscopic retrograde cholangiopancreatography Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : January 24, 2020
Actual Primary Completion Date : March 20, 2020
Actual Study Completion Date : May 6, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

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 Name: 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 Name: ERCP




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Rate of use of advanced cannulation techniques [ Time Frame: 1 day ]
    Need for use of advanced cannulation techniques

  4. Rate of cross-over [ Time Frame: 1 day ]
    Rate of cross-over to the alternate duodenoscope for completion of the procedure

  5. Time taken for cannulation [ Time Frame: 1 day ]
    Time taken for cannulation

  6. Total duration of the procedure [ Time Frame: 1 day ]
    Total duration of the procedure

  7. Rate of adverse events [ Time Frame: 7 days and 30 days ]
    Assessment of AEs and SAEs



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04143698


Locations
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United States, Florida
AdventHealth Orlando
Orlando, Florida, United States, 32803
Sponsors and Collaborators
AdventHealth
Investigators
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Principal Investigator: Shyam Varadarajulu, MD AdventHealth Orlando
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: AdventHealth
ClinicalTrials.gov Identifier: NCT04143698    
Other Study ID Numbers: 1388902
First Posted: October 29, 2019    Key Record Dates
Last Update Posted: June 23, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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