Clinical trial NCT05735678: Single-USe Duodenoscopes PErformance Characteristics and Technical Outcomes: the SUSPECT Italian Prospective Study
Official title: Single-USe Duodenoscopes PErformance Characteristics and Technical Outcomes: the SUSPECT Italian Prospective Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Disease of Gastrointestinal Tract
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2023-02-21
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled for a clinically indicated ERCP or other duodenoscope-based procedure will be enrolled in the study

Brief summary: Flexible endoscopes are used globally for the diagnosis and treatment of diseases of the GI tract. Duodenoscopes used for Endoscopic Retrograde Cholangiopancreatography (ERCP), in order to treat different biliary and pancreatic disorders, have been recently linked to infections transmission following the procedures. Given their reusability and their complex design of the tip with a moving metallic component, named the "elevator", these instruments must be reprocessed through high level disinfection (HLD) in order to prevent the spread of nosocomial infections. Even strict adherence to all HLD procedures results in a residual level of potentially infectious microbes. In fact, the United States Food and Drug Administration (FDA) postmarket surveillance communication reported duodenoscope culture results demonstrating contamination rates of up to 3.6% for low and moderate-concern organisms and up to 5.4% for high-concern organisms in reprocessed conventional duodenoscopes. As a consequence, at least 20 outbreaks of duodenoscope-transmitted multidrug resistant organism (MDRO) infections occurred between 2012 and 2015, despite reported compliance with duodenoscope reprocessing guidelines. The increasing concern that currents practices of reprocessing reusable duodenoscopes is insufficient, has led the FDA to released recommendation suggesting to develope a newly designed duodenoscopes. On one hand, a way is to generate duodenoscope with disposable components, such as a one-use end cap, which can be removed and allow access to the components of the elevator and other areas of the duodenoscope for reprocessing. On the other hand, an alternative is to produce a fully disposable single-use duodenoscope. The evident advantage of a single use duodenoscope, over disposable components, is that it completely eliminates the need for reprocessing and more important the risk of transmitting microbial infection from patient to patient.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Willing and able to comply with the study procedures and provide written informed consent to participate in the study
* Schedule for a clinically indicated ERCP or other duodenoscope-based procedure

Exclusion Criteria:

* Potentially vulnerable subjects, including, but not limited to pregnant women
* Subjects for whom endoscopic techniques are contraindicated
* Subjects who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor

Primary outcomes:
measure: Technical performance
timeFrame: 24 months
measure: Procedural performance
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Department of Gastroenterology, Humanitas Research Hospital
state: Milano
Study officials:
References: