NCT05303662

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,244 (actual)
• Sponsor: Marco J. Bruno · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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

Type	Name	Description
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

Timeline

• Start date: 2022-01-31
• Primary completion: 2024-12-30
• Completion: 2024-12-30
• First posted: 2022-03-31
• Last updated: 2025-08-08

Locations

4 sites across 4 countries: United States, India, Italy, Netherlands