Duodenoscope Disinfect Study

March 11, 2017 updated by: Mandeep Sawhney, Beth Israel Deaconess Medical Center

Prospective Randomized Double-blinded Trial Comparing Three Duodenoscope High- Level Disinfection and Sterilization Procedures

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

541

Phase

  • Not Applicable

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. 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

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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)
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
Standard high level disinfectant (metricide ortho-phthalaldehyde) followed by ethylene oxide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
6 months

Collaborators and Investigators

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

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.

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

November 1, 2015

Primary Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

November 12, 2015

First Submitted That Met QC Criteria

November 19, 2015

First Posted (Estimate)

November 23, 2015

Study Record Updates

Last Update Posted (Actual)

March 14, 2017

Last Update Submitted That Met QC Criteria

March 11, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 2015P000263

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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