Prevalence of multidrug resistant micro-organism carriage in patients undergoing an ERCP in four different countries

Over the last two decades it has become clear that one of the risks of
endoscopic retrograde cholangiopancreatography (ERCP) is transmission of
microorganisms through contaminated re-usable duodenoscopes. This is especially
of concern when this involves multidrug resistant microorganisms (MDRO).
Transmission of MDRO by contaminated re-usable duodenoscopes to multiple
patients is now increasingly encountered. Since these re-usable instruments
cannot be sterilized, they require an extensive, and unfortunately error prone,
reprocessing technique. Despite several efforts to overcome this problem, new
outbreaks are still being reported and new reprocessing techniques are not
capable of producing a zero contamination rate. 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 duodenoscopes completely eliminate the risk of
becoming infected or colonized by microorganisms originating from other
patients. However, a complete transition towards disposable duodenoscopes
requires a huge investment. Whether this investment outweighs the risk of
contamination depends on the prevalence of MDRO and the risk of
duodenoscope-associated infections (DAI). However, there is no known prevalence
of MDRO in patients undergoing ERCP and the risk of DAI is not known.

The primary aim of the study is to assess the prevalence of MDRO carriage in
patients undergoing ERCPs. This will be performed in four different countries
with expected significantly different prevalence rates of MDRO carriage,
namely: India, United States, Italy and the Netherlands. The MDRO included in
this study are Carbapenemase-producing Enterobacterales (CPE),
Carbapenemase-producing Pseudomonas (CPP), Extended spectrum Beta
Lactamase-producing Enterobacterales (ESBL), Vancomycin-resistant Enterococci
(VRE) and Methicillin-resistant Staphylococcus aureus (MRSA).

Secondary questions include: Only for the cohort from the Netherlands
- To identify risk factors that predict MDRO carriage.
- Prevalence of contamination of duodenoscopes in a Dutch tertiary care setting.
- If the presence of MDRO's in the rectal and nasal/throat E-swabs predicts the
presence of MDRO's in the duodenum.
- What is the composition of the duodenal microbiome of patients undergoing an
ERCP.
- What is the composition of the rectal microbiome of patients undergoing an
ERCP.
- What is the incidence of duodenoscope-associated colonization and infection
in patients who have been treated with a colonized duodenoscope.

Prospective observational multi-center study

Patients will be asked to fill in a questionnaire about the risk factors of
MDRO-carriage, this is minimally burdensome. A throat/nose swab will be taken
prior to the ERCP. This is completely safe, and can be taken with minimal
discomfort. After the patient has been sedated, two rectal E-swabs will be
taken before the start of the ERCP. This is also negligibly risky and the
patient does not experience any discomfort because of the sedation.

In the Netherlands, a small amount of duodenal fluid will be aspirated through
a sterile catheter during the ERCP procedure. The collection of the fluid is
non-invasive and negligibly risky, prolonging the ERCP duration to a minimum.
The patient does not experience any discomfort from this action.

In the Netherlands, if patients have been treated with a duodenoscope colonized
with oral or gastrointestinal flora, they will be requested to collect some
feces at home and send/or bring this to the laboratory.

There are no benefits for patients from participating in this study.