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Microbiology in Obstructive BIliary Disease

Clinical-Microbiological Evaluation of the Obstructive Biliary Disease

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05464693
Enrollment
70
Registered
2022-07-19
Start date
2021-08-24
Completion date
2022-08-30
Last updated
2022-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biliary Disease

Brief summary

Patients admitted to hospital due to obstructive biliary disease secondary to benign and malign etiologies, undergoing ERCP, will be selected. Bile sample will be taken in ERCP procedure with sterile technique. Its macroscopic appearance will be assessed and biliary culture will be performed.

Detailed description

The sample of biliary aspirate will be assessed as follows. 1. Its macroscopic appearance will be analyzed: yellow, black, or purulent. 2. Biliary culture will be performed; if bacterial growth is observed, its identification will be carried out by means of MALDI-TOF MS mass spectrometry and antibiotic susceptibility tests will be carried out, using the automated VITEK system.

Interventions

DIAGNOSTIC_TESTERCP biliary culture

The sample of biliary aspirate will be assessed as follows. 1. Its macroscopic appearance will be analyzed: yellow, black, or purulent. 2. Biliary culture will be performed; if bacterial growth is observed, its identification will be carried out by means of MALDI-TOF MS mass spectrometry and antibiotic susceptibility tests will be carried out, using the automated VITEK system.

Sponsors

Hospital Universitario Dr. Jose E. Gonzalez
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients with diagnosis or suspicion of biliary obstruction of any cause * Any gender * Over 18 years of age

Exclusion criteria

* Patients referred and previously treated at another hospital/clinic * Previous ERCP * Pregnancy * Patient refusal to enter the study

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of bacterial isolation in the obstructive biliary disease measured by percentage calculation1 yearDetermine the prevalence by percentage measurement of bacterial isolation in bile fluid in the obstructive biliary disease in patients undergoing ERCP.

Secondary

MeasureTime frameDescription
Bacteria in the obstructed bile duct1 yearIsolate and identify most common bacteria that colonize and infect the obstructed bile duct by means of biliary culture and MALDI-TOF MS mass spectrometry, respectively
Antibiotic susceptibility of isolated bacteria in bile fluid1 yearDetermine antibiotic susceptibility of the isolated bacteria in bile fluid of patients with obstructed bile duct by means of the automated VITEK system
Bacteria and etiology of obstructive biliary disease1 yearAssociation between isolated bacteria and the etiology of obstructive biliary disease

Countries

Mexico

Contacts

Primary ContactMarusia González Villarreal
marusia1990@hotmail.com8112525250
Backup ContactJoel Omar Jáquez Quintana
jomjaqui@hotmail.com8114183484

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026