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

NCT05303662 | Completed

• 1 other identifier: NL79136.078
• Study Type: observational
• Target: 1,244
• Locations: 4 countries
• Sites: 4

Brief 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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

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

  1 week

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

  1 week

• Prevalence of duodenoscope-associated infections and colonizations

  6 months

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

  1 week

Study Arms (4)

ERCP-patients Netherlands

Patients undergoing ERCP in the study site in the Netherlands

Diagnostic Test: 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

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

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

ERCP-patients India

Patients undergoing ERCP in the study site in India

Diagnostic Test: Multidrug-Resistant Organisms (MDRO) testing through rectal and oral/nasal swabs; Diagnostic Test: MDRO-testing duodenal aspirate

Interventions

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

ERCP-patients India; ERCP-patients Italy; ERCP-patients Netherlands; ERCP-patients United States

MDRO-testing duodenal aspirate DIAGNOSTIC_TEST

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

ERCP-patients India; ERCP-patients Netherlands

Microbiome through rectal swab DIAGNOSTIC_TEST

An rectal swab is collected for microbiome purposes

ERCP-patients Netherlands

Microbiome testing duodenal aspirate DIAGNOSTIC_TEST

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

ERCP-patients Netherlands

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing ERCP procedures irrespective of the indication for that procedure

You may qualify if:

• 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

Sponsors & Collaborators

• Marco J. Bruno: lead
• Boston Scientific Corporation: collaborator

Study Sites (4)

UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

AIG hospitals

Hyderabad, Telangana, 500032, India

Location

Humanitas research hospital

Milan, Lombardy, 20089, Italy

Location

Erasmus MC

Rotterdam, South Holland, 3015GD, Netherlands

Location

Related Publications (2)

• 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.

  PMID: 29636382 BACKGROUND

• van der Ploeg K, Vos MC, Rughwani H, Severin JA, Post RAJ, Reddy DN, Veturi SY, Sasikala M, Memon SF, Repici A, Spadaccini M, Colombo M, Andreozzi M, Stevens BA, Das R, Slivka A, Mason-Slingerland BCGC, Bruno MJ. Preprocedural screening for multidrug-resistant organisms in endoscopic retrograde cholangiopancreatography: an international, multicentre, cross-sectional observational study. EClinicalMedicine. 2025 Nov 13;90:103627. doi: 10.1016/j.eclinm.2025.103627. eCollection 2025 Dec.

  PMID: 41324017 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Only in the Netherlands biospecimen retention will take place to study secondary objectives: feces, urine, wound tissue, blood, bile, rectal swabs, duodenal aspirate.

Study Officials

• M. J. Bruno, Professor

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Gastroenterology and Hepatology

Study Record Dates

• First Submitted: March 17, 2022
• First Posted: March 31, 2022
• Study Start: January 31, 2022
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: August 8, 2025

Record last verified: 2025-08

Locations

NL (1); IN (1); US (1); IT (1)