Clinical trial NCT05303662: Prevalence of Multidrug Resistant Micro-organism Carriage in Patients Undergoing an ERCP in Four Different Countries
Official title: Prevalence of Multidrug Resistant Micro-organism Carriage in Patients Undergoing an Endoscopic Retrograde Cholangiopancreatography in Four Different Countries
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Drug Resistance, Multiple, Bacterial
Cholangiopancreatography, Endoscopic Retrograde
Keywords: Cholangiopancreatography, Endoscopic Retrograde
Drug Resistance, Multiple, Bacterial
Equipment Contamination
Duodenoscope associated infection
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2022-03-31
Enrollment: 1372
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing ERCP procedures irrespective of the indication for that procedure

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.


Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of multidrug resistant micro-organism carriage in patients undergoing an ERCP in four different countries
timeFrame: 1 week
Secondary outcomes:
measure: Prevalence of multidrug resistant micro-organism carriage in the duodenum of patients undergoing ERCP compared to the rectum
timeFrame: 1 week
measure: Differences of rectal microbiome between ERCP patients carrying MDRO compared to patients without MDRO
timeFrame: 1 week
measure: Prevalence of duodenoscope-associated infections and colonizations
timeFrame: 6 months
measure: Differences of duodenal microbiome between ERCP patients carrying MDRO compared to patients without MDRO
timeFrame: 1 week
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC
state: Pennsylvania
city: Hyderabad
country: India
facility: AIG hospitals
state: Telangana
city: Milano
country: Italy
facility: Humanitas research hospital
state: Lombardy
city: Rotterdam
country: Netherlands
facility: Erasmus MC
state: Zuid-Holland
Study officials:
affiliation: Erasmus Medical Center
name: M. J. Bruno, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.