NCT05464693

Microbiology in Obstructive BIliary Disease

Clinical-Microbiological Evaluation of the Obstructive Biliary Disease

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 70 (estimated)
• Sponsor: Hospital Universitario Dr. Jose E. Gonzalez · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Biliary Disease

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	ERCP 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.

Timeline

• Start date: 2021-08-24
• Primary completion: 2022-08-30
• Completion: 2022-08-30
• First posted: 2022-07-19
• Last updated: 2022-07-21

Locations

1 site across 1 country: Mexico