Microbiology in Obstructive BIliary Disease

Study Overview
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Brief Summary
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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
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The sample of biliary aspirate will be assessed as follows. Its macroscopic appearance will be analyzed: yellow, black, or purulent. 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.

Official Title
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Clinical-Microbiological Evaluation of the Obstructive Biliary Disease

Conditions
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Biliary Disease

Intervention / Treatment
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* Diagnostic Test: ERCP biliary culture


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with obstructive biliary disease<br>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. | Diagnostic Test: ERCP biliary culture<br>* The sample of biliary aspirate will be assessed as follows. Its macroscopic appearance will be analyzed: yellow, black, or purulent. 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.<br>* Other names: Antibiotic susceptibility for identified bacteria;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of bacterial isolation in the obstructive biliary disease measured by percentage calculation | Determine the prevalence by percentage measurement of bacterial isolation in bile fluid in the obstructive biliary disease in patients undergoing ERCP. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bacteria in the obstructed bile duct | Isolate 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 | 1 year | 
| Antibiotic susceptibility of isolated bacteria in bile fluid | Determine antibiotic susceptibility of the isolated bacteria in bile fluid of patients with obstructed bile duct by means of the automated VITEK system | 1 year | 
| Bacteria and etiology of obstructive biliary disease | Association between isolated bacteria and the etiology of obstructive biliary disease | 1 year |