Duodenoscope Disinfect Study

NCT ID: NCT02611648

Last Updated: 2017-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 541 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30

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.

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.

Conditions

Endoscopic Retrograde Cholangiopancreatogram (ERCP)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

standard HLD

Standard high-level disinfectant (metricide ortho-phthalaldehyde) currently performed at BIDMC (standard HLD)

Group Type: NO_INTERVENTION

No interventions assigned to this group

double HLD

Double the exposure time of the standard high level disinfectant (metricide ortho-phthalaldehyde)

Group Type: EXPERIMENTAL

Double HLD

Intervention Type: OTHER

Standard high level disinfectant (metricide ortho-phthalaldehyde) with an additional exposure time to disinfect

HLD/ETO

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

Group Type: EXPERIMENTAL

HLD/ETO

Intervention Type: OTHER

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

Interventions

Double HLD

Standard high level disinfectant (metricide ortho-phthalaldehyde) with an additional exposure time to disinfect

Intervention Type: OTHER

HLD/ETO

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Mandeep Sawhney

Mandeep Sawhney, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

Snyder GM, Wright SB, Smithey A, Mizrahi M, Sheppard M, Hirsch EB, Chuttani R, Heroux R, Yassa DS, Olafsdottir LB, Davis RB, Anastasiou J, Bapat V, Bidari K, Pleskow DK, Leffler D, Lane B, Chen A, Gold HS, Bartley A, King AD, Sawhney MS. Randomized Comparison of 3 High-Level Disinfection and Sterilization Procedures for Duodenoscopes. Gastroenterology. 2017 Oct;153(4):1018-1025. doi: 10.1053/j.gastro.2017.06.052. Epub 2017 Jul 13.

Reference Type: DERIVED

PMID: 28711629 (View on PubMed)

Other Identifiers

2015P000263

Identifier Type: -

Identifier Source: org_study_id