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Prevalence of Multidrug Resistant Micro-organism Carriage in Patients Undergoing an Endoscopic Retrograde Cholangiopancreatography in Four Different Countries
The duodenoscopes currently used for Endoscopic Retrograde Cholangio - and Pancreaticography (ERCP) examinations are reusable and are therefore washed and disinfected after each use. Despite this, these endoscopes sometimes remain contaminated with bacteria. Several reports of outbreaks linked to contaminated duodenoscopes have been published worldwide. Recently, the Food and Drug Administration (FDA) advised manufacturers and health care professionals to transition away from fixed endcap duodenoscopes and instead focus more on the use of duodenoscopes with disposable components or fully disposable duodenoscopes. Single-use endoscopes have been developed, but they are not yet widely used, partly because of the extra costs that these endoscopes add to the examination. A possible interim solution, is to only use these disposable endoscopes in patients who carry multi-resistant bacteria in order to prevent the spread of these bacteria. For this, it is important to know how many people who undergo an ERCP carry multi-resistant bacteria. The primary objective of this study is to measure the prevalence of multi-resistant bacteria in patients undergoing ERCP in four different countries: India, the Netherlands, Italy and the United States. In the Netherlands, some secondary outcomes will be investigated with regard to the prevalence of duodenoscope contamination, the risk of bacterial transmission via a contaminated duodenoscope and the presence of multi-resistant bacteria in the duodenum.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
UPMC
Pittsburgh, Pennsylvania, United States
AIG hospitals
Hyderabad, Telangana, India
Humanitas research hospital
Milan, Lombardy, Italy
Erasmus MC
Rotterdam, South Holland, Netherlands
Start Date
January 31, 2022
Primary Completion Date
December 30, 2024
Completion Date
December 30, 2024
Last Updated
August 8, 2025
1,244
ACTUAL participants
Multidrug-Resistant Organisms (MDRO) testing through rectal and oral/nasal swabs
DIAGNOSTIC_TEST
MDRO-testing duodenal aspirate
DIAGNOSTIC_TEST
Microbiome through rectal swab
DIAGNOSTIC_TEST
Microbiome testing duodenal aspirate
DIAGNOSTIC_TEST
Lead Sponsor
Marco J. Bruno
Collaborators
NCT06738771
NCT04572711
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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