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

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.

Study Overview

• Status: Completed
• Conditions: Cholangiopancreatography, Endoscopic Retrograde; Drug Resistance, Multiple, Bacterial
• Intervention / Treatment: Diagnostic test: MDRO-testing duodenal aspirate; Diagnostic test: Microbiome through rectal swab; Diagnostic test: Microbiome testing duodenal aspirate; Diagnostic test: Multidrug-Resistant Organisms (MDRO) testing through rectal and oral/nasal swabs

• Study Type: Observational
• Enrollment (Actual): 1244

Contacts and Locations

Study Locations

• India
  • Telangana
    • Hyderabad, Telangana, India, 500032
      • AIG Hospitals
• Italy
  • Lombardy
    • Milano, Lombardy, Italy, 20089
      • Humanitas Research Hospital
• Netherlands
  • Zuid-Holland
    • Rotterdam, Zuid-Holland, Netherlands, 3015GD
      • Erasmus MC
• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Patients undergoing ERCP procedures irrespective of the indication for that procedure

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ERCP-patients Netherlands; Patients undergoing ERCP in the study site in the Netherlands	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; 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
ERCP-patients Italy; Patients undergoing ERCP in the study site in Italy	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
ERCP-patients United States; Patients undergoing ERCP in the study site in the Netherlands	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
ERCP-patients India; Patients undergoing ERCP in the study site in India	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: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of multidrug resistant micro-organism carriage in patients undergoing an ERCP in four different countries	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.	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of multidrug resistant micro-organism carriage in the duodenum of patients undergoing ERCP compared to the rectum	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.	1 week
Differences of rectal microbiome between ERCP patients carrying MDRO compared to patients without MDRO	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.	1 week
Prevalence of duodenoscope-associated infections and colonizations	Comparison of isolates form duodenoscope cultures with isolates from clinical cultures from patients treated with a contaminated duodenoscope in order to detect transmission.	6 months
Differences of duodenal microbiome between ERCP patients carrying MDRO compared to patients without MDRO	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.	1 week

Collaborators and Investigators

• Sponsor: Marco J. Bruno
• Collaborators: Boston Scientific Corporation
• Investigators: Principal Investigator: M. J. Bruno, Professor, Erasmus Medical Center

Publications and helpful links

General Publications

• Rauwers AW, Voor In 't Holt AF, Buijs JG, de Groot W, Hansen BE, Bruno MJ, Vos MC. High prevalence rate of digestive tract bacteria in duodenoscopes: a nationwide study. Gut. 2018 Sep;67(9):1637-1645. doi: 10.1136/gutjnl-2017-315082. Epub 2018 Apr 10.

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2022
• Primary Completion (Actual): December 30, 2024
• Study Completion (Actual): December 30, 2024

Study Registration Dates

• First Submitted: March 17, 2022
• First Submitted That Met QC Criteria: March 28, 2022
• First Posted (Actual): March 31, 2022

Study Record Updates

• Last Update Posted (Actual): August 8, 2025
• Last Update Submitted That Met QC Criteria: August 6, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Cholangiopancreatography, Endoscopic Retrograde; Drug Resistance, Multiple, Bacterial; Equipment Contamination; Duodenoscope associated infection
• Other Study ID Numbers: NL79136.078

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No