Microbiology in Obstructive BIliary Disease

• Conditions: Biliary Disease
• Interventions: Diagnostic Test: ERCP biliary culture

• Registration Number: NCT05464693
• Lead Sponsor: Hospital Universitario Dr. Jose E. Gonzalez

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.

Study Timeline

• Study Start: 2021-08-24
• Study First Submitted: 2022-06-15
• Status Verified: 2022-07
• Study First Submitted QC: 2022-07-15
• Study First Posted: 2022-07-19
• Last Update Submitted: 2022-07-19
• Last Update Posted: 2022-07-21
• Primary Completion: 2022-08-30
• Study Completion: 2022-08-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with obstructive biliary disease	ERCP biliary culture	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.

Primary Outcome Measures

Name	Time	Method
Prevalence of bacterial isolation in the obstructive biliary disease measured by percentage calculation	1 year	Determine the prevalence by percentage measurement of bacterial isolation in bile fluid in the obstructive biliary disease in patients undergoing ERCP.

Secondary Outcome Measures

Name	Time	Method
Bacteria in the obstructed bile duct	1 year	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
Antibiotic susceptibility of isolated bacteria in bile fluid	1 year	Determine 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 disease	1 year	Association between isolated bacteria and the etiology of obstructive biliary disease

Trial Locations

Locations (1)

Marusia González Villarreal; 🇲🇽 Monterrey, Nuevo León, Mexico