COMPLETED

Prevalence of Multidrug Resistant Micro-organism Carriage in Patients Undergoing an ERCP in Four Different Countries

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Prevalence of Multidrug Resistant Micro-organism Carriage in Patients Undergoing an Endoscopic Retrograde Cholangiopancreatography in Four Different Countries

Quick Facts

Study Start:2022-01-31
Study Completion:2024-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05303662

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Not specified
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * The subject is planned to undergo an ERCP procedure, either through an outpatient department or an inpatient department
  2. * The subject is capable to understand the information required to give informed consent
  1. * In case the inclusion criteria were not met

Contacts and Locations

Principal Investigator

M. J. Bruno, Professor
PRINCIPAL_INVESTIGATOR
Erasmus Medical Center

Study Locations (Sites)

UPMC
Pittsburgh, Pennsylvania, 15213
United States

Collaborators and Investigators

Sponsor: Marco J. Bruno

  • M. J. Bruno, Professor, PRINCIPAL_INVESTIGATOR, Erasmus Medical Center

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 Registration Dates

Study Start Date2022-01-31
Study Completion Date2024-12-30

Study Record Updates

Study Start Date2022-01-31
Study Completion Date2024-12-30

Terms related to this study

Keywords Provided by Researchers

  • Cholangiopancreatography, Endoscopic Retrograde
  • Drug Resistance, Multiple, Bacterial
  • Equipment Contamination
  • Duodenoscope associated infection

Additional Relevant MeSH Terms

  • Drug Resistance, Multiple, Bacterial
  • Cholangiopancreatography, Endoscopic Retrograde