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Duodenoscope Disinfect Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02611648
Recruitment Status : Completed
First Posted : November 23, 2015
Last Update Posted : March 14, 2017
Information provided by (Responsible Party):
Mandeep Sawhney, Beth Israel Deaconess Medical Center

Brief Summary:

This study is investigating the most effective way to sterilize duodenoscopes ("scopes") used at Beth Israel Deaconess Medical Center (BIDMC). Right now, BIDMC uses the standard method of high level disinfection to sterilize scopes. Because infections have been passed by scopes at other institutions in the U.S., the investigators are exploring whether or not adding two different sterilization processes will reduce this risk of contamination.

Bacteria may be passed from a patient's intestines to the scope. Or, if the scope is contaminated, bacteria may be passed from the scope to the patient. In order to understand how bacteria are passed, the investigators will be taking samples of the patient's intestinal bacteria to compare to the bacteria, if any, found on the scope.

Condition or disease Intervention/treatment Phase
Endoscopic Retrograde Cholangiopancreatogram (ERCP) Other: Double HLD Other: HLD/ETO Not Applicable

Detailed Description:

Study Design

This study is designed to evaluate the effect of supplementing standard high-level disinfection with additional high level-disinfection or sterilization procedures on the frequency of duodenoscopes contamination. Duodenoscopes will be randomly assigned to one of three arms:

  • Standard high-level disinfection currently performed at BIDMC (standard HLD)
  • Standard high-level disinfection with an additional exposure time to disinfectant (double HLD)
  • Standard high-level disinfection followed by ethylene oxide (HLD/ETO)

The study will be conducted with the following elements:

  1. All duodenoscopes will be randomly assigned to a study arm before the duodenoscope is used for an Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedure included in the study, including duodenoscopes introduced during the study.
  2. All duodenoscopes used for ERCP will have the following cultures obtained in a sterile fashion
  3. Patient study consent for obtaining patient rectal surveillance and clinical cultures will be obtained at the time of ERCP procedure consent among all patients undergoing ERCP. Patients will be blinded to duodenoscope disinfection/sterilization assignment.
  4. The ERCP procedure will be performed according to standard clinical practice. Among patients consenting to specimen collection, a duodenal aspirate will be obtained during the procedure.
  5. Among consenting patients, a rectal surveillance swab will be collected post-procedurally by ERCP staff.
  6. After ERCP completion, current BIDMC-employed trained technicians will perform the assigned disinfection/sterilization procedure.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 541 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Prospective Randomized Double-blinded Trial Comparing Three Duodenoscope High- Level Disinfection and Sterilization Procedures
Study Start Date : November 2015
Actual Primary Completion Date : March 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: standard HLD
Standard high-level disinfectant (metricide ortho-phthalaldehyde) currently performed at BIDMC (standard HLD)
Experimental: double HLD
Double the exposure time of the standard high level disinfectant (metricide ortho-phthalaldehyde)
Other: Double HLD
Standard high level disinfectant (metricide ortho-phthalaldehyde) with an additional exposure time to disinfect

Experimental: HLD/ETO
Standard high level disinfectant (metricide ortho-phthalaldehyde) followed by ethylene oxide
Other: HLD/ETO
Standard high level disinfectant (metricide ortho-phthalaldehyde) followed by ethylene oxide

Primary Outcome Measures :
  1. Frequency of contaminated duodenoscopes after using three different types of disinfection processes [ Time Frame: 6 months ]
    Compare the frequency of duodenoscope contamination after reprocessing using 3 different methods: standard high-level disinfection procedure with ortho-phthalaldehyde (standard HLD), double cycle of standard high-level disinfection (double HLD), and standard high-level disinfection followed by ethylene oxide (ETO) gas sterilization (HLD/ETO)

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

Inclusion Criteria:

  1. A duodenoscope used for any intended ERCP procedure will be included in the study
  2. All adult patients (age ≥18 years) scheduled to undergo ERCP will be offered participation in patient specimen collection component of the study

Exclusion Criteria:

  1. Patients in whom ERCP or endoscopy with a duodenoscope is medically contra-indicated will not be included in the patient specimen collection portion of the study
  2. Patients with surgically altered anatomy in whom ERCP is performed using an enteroscope (and not a duodenoscope) will not be included in the study
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Mandeep Sawhney, Mandeep Sawhney, MD, Beth Israel Deaconess Medical Center Identifier: NCT02611648    
Other Study ID Numbers: 2015P000263
First Posted: November 23, 2015    Key Record Dates
Last Update Posted: March 14, 2017
Last Verified: March 2017