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

Completed

Conditions studied: Drug Resistance, Multiple, Bacterial, Cholangiopancreatography, Endoscopic Retrograde

In brief

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.

Key facts

Study ID

NCT05303662

Run by

Marco J. Bruno

People needed

1244

Starts

2022-01-31

Expected to finish

2024-12-30

Last updated by the study team

2025-08-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

You may not qualify if…

• In case the inclusion criteria were not met

Where it is running

• UPMC — Pittsburgh, Pennsylvania, United States
• AIG hospitals — Hyderabad, Telangana, India
• Humanitas research hospital — Milan, Lombardy, Italy
• Erasmus MC — Rotterdam, South Holland, Netherlands

Full record on ClinicalTrials.gov

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