Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1700 participants
OBSERVATIONAL
2024-01-08
2026-01-05
Brief Summary
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Detailed Description
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Microbial cultures from bile and blood samples will be established and characterized using appropriate methodologies. For patients with moderate and severe acute cholangitis (AC), blood cultures will be initiated upon admission, adhering to the Tokyo Guidelines for AC 2018 recommendations. Bile specimens will be obtained after cannulation through the sphincterotome before the therapeutic intervention. Initially, a minimum of 5 mL of the procured bile will be discarded, followed by the collection of an additional 5 mL in a sterile vessel containing a medium conducive to both anaerobic and aerobic bacterial cultures. The samples will undergo a minimum incubation period of seven days at 37 °C until microbial proliferation becomes evident. Antibiotic susceptibility assessments, specifically minimum inhibitory concentration (MIC), will be performed and interpreted according to established guidelines.The analysis of samples will occur within the laboratory of each respective center, with antibiograms conducted in accordance with established protocols.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients with acute cholangitis
Patients admitted to the hospital due to acute cholangitis and undergoing ERCP will be selected. Bile specimens will be obtained after cannulation through the sphincterotome before the therapeutic intervention.
ERCP
ERCP will serve as the exclusive therapeutic modality, aided by a therapeutic duodenoscope to access the common bile duct using a guidewire.
Interventions
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ERCP
ERCP will serve as the exclusive therapeutic modality, aided by a therapeutic duodenoscope to access the common bile duct using a guidewire.
Eligibility Criteria
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Inclusion Criteria
* Ability to provide an informed consent
* Age over 18 years
* Any gender
Exclusion Criteria
* Pregnancy
* Post-ERCP perforation
* The patient's decision to abstain from study enrollment
* Patients unable to express informed consent
* Patients from whom a bile sample could not be collected.
18 Years
ALL
No
Sponsors
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Carol Davila University of Medicine and Pharmacy
OTHER
Grigore T. Popa University of Medicine and Pharmacy
OTHER
Bucharest Emergency Hospital
OTHER
Emergency County Hospital Pius Brinzeu; Timisoara, Romania
NETWORK
Responsible Party
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Bogdan Miutescu, MD
MD,PhD
Principal Investigators
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Bogdan Miutescu, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Emergency County Hospital Pius Brinzeu; Timisoara, Romania
Locations
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Bogdan Miutescu
Timișoara, , Romania
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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407/29.09.2023
Identifier Type: -
Identifier Source: org_study_id
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