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

NCT05303662 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1244

Last updated 2025-08-08

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DIAGNOSTIC_TEST

Multidrug-Resistant Organisms (MDRO) testing through rectal and oral/nasal swabs

Pooled throat/nose sample and a rectal sample is taken prior to the ERCP

DIAGNOSTIC_TEST

MDRO-testing duodenal aspirate

Duodenal aspirate is collected from the duodenum, diluted and undiluted. Then cultured for presence of MDRO's

DIAGNOSTIC_TEST

Microbiome through rectal swab

An rectal swab is collected for microbiome purposes

DIAGNOSTIC_TEST

Microbiome testing duodenal aspirate

Duodenal aspirate is collected from the duodenum, diluted and undiluted for microbiome analysis

Sponsors & Collaborators

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • Marco J. Bruno

    lead OTHER

Principal Investigators

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

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-31
Primary Completion
2024-12-30
Completion
2024-12-30

Countries

  • United States
  • India
  • Italy
  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05303662 on ClinicalTrials.gov