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NCT Number: NCT05303662

Prevalence of Multidrug Resistant Micro-organism Carriage in Patients Undergoing an ERCP 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.

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Key information

Conditions

Drug Resistance, Multiple, Bacterial Cholangiopancreatography, Endoscopic Retrograde

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AIG hospitals, Hyderabad, Telangana, India

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Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The subject is planned to undergo an ERCP procedure, either through an outpatient department or an inpatient department
  • The subject is capable to understand the information required to give informed consent

Exclusion criteria

  • In case the inclusion criteria were not met

Treatment and study plan

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

Diagnostic Test

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

MDRO-testing duodenal aspirate

Diagnostic Test

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

Microbiome through rectal swab

Diagnostic Test

An rectal swab is collected for microbiome purposes

Microbiome testing duodenal aspirate

Diagnostic Test

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

Primary outcomes

  1. Prevalence of multidrug resistant micro-organism carriage in patients undergoing an ERCP in four different countries

    Time frame: 1 week

    Prevalence (as a percentage) of Methicillin-resistant Staphylococcus aureus (MRSA) in nasal or throat swabs, along with rectal carriage rates of Extended Spectrum Beta-Lactamase (ESBL), Vancomycin-resistant Enterococci (VRE), Carbapenem-resistant Enterobacterales (CRE), Carbapenemase-Producing Pseudomonas aeruginosa (CPP), and resistant Acinetobacter among ERCP patients in India, the Netherlands, Italy, and the United States.

Secondary outcomes

  1. Prevalence of multidrug resistant micro-organism carriage in the duodenum of patients undergoing ERCP compared to the rectum

    Time frame: 1 week

    Prevalence (as a percentage) of duodenal carriage of MRSA, ESBL, VRE, CRE, CPP, and resistant Acinetobacter among ERCP patients in both India and the Netherlands.

  2. Differences of rectal microbiome between ERCP patients carrying MDRO compared to patients without MDRO

    Time frame: 1 week

    Sequencing data analysis, such as 16S rRNA gene sequencing, will be used to assess the overall composition of the rectal microbiome. This will involve the identification of various bacterial taxa present in the samples and determining their relative proportions. The results will provide information on the broader microbial community composition.

    These results will be compared between ERCP patients carrying MDRO and those without MDRO to investigate differences in both specific bacterial species' abundance and overall microbiome composition.

  3. Prevalence of duodenoscope-associated infections and colonizations

    Time frame: 6 months

    Comparison of isolates form duodenoscope cultures with isolates from clinical cultures from patients treated with a contaminated duodenoscope in order to detect transmission.

  4. Differences of duodenal microbiome between ERCP patients carrying MDRO compared to patients without MDRO

    Time frame: 1 week

    Sequencing data analysis, such as 16S rRNA gene sequencing, will be used to assess the overall composition of the duodenal microbiome. This will involve the identification of various bacterial taxa present in the samples and determining their relative proportions. The results will provide information on the broader microbial community composition.

    These results will be compared between ERCP patients carrying MDRO and those without MDRO to investigate differences in both specific bacterial species' abundance and overall microbiome composition.

Sponsors and collaborators

Lead sponsor

Marco J. Bruno

Other

Collaborators

  • Boston Scientific Corporation

Registry information

Official study title

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

Acronym: PREVENT

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 31, 2022
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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