An observational study in Biliary Disease, sponsored by Hospital Universitario Dr. Jose E. Gonzalez. Status unknown at 1 site in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-21.
Sponsored by Hospital Universitario Dr. Jose E. Gonzalez · Observational
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.
The sample of biliary aspirate will be assessed as follows.
92 studies on the registry are indexed under Gallbladder Diseases; 19 are open to participants now.
This study's planned enrollment of 70 is below the median of 220 across 29 observational studies indexed under Gallbladder Diseases.
Browse Gallbladder Diseases studies →Hospital Universitario Dr. Jose E. Gonzalez is the lead sponsor of 83 studies on the registry; 12 are open to participants now.
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Patients admitted to the Emergency Department with a diagnosis of obstructive biliary disease of any cause, according to clinical, laboratory, and imaging data, who have indicated an Endoscopic Retrograde Cholangiopancreatography as part of their management.
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Exclusion Criteria:
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
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.
Also known as: MALDI-TOF MS mass spectrometry for bacteria identification, Antibiotic susceptibility for identified bacteria
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.
Time frame: 1 year
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
Time frame: 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
Time frame: 1 year
Bacteria and etiology of obstructive biliary disease
Association between isolated bacteria and the etiology of obstructive biliary disease
Time frame: 1 year
Plan to share: No — No data sharing plan
This study is status unknown, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Hospital Universitario Dr. Jose E. Gonzalez