Microbial Analysis in Patients With Cholangitis

NCT ID: NCT04216745

Last Updated: 2021-01-13

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2021-05-30

Brief Summary

• To identify the microbial profile in bile and blood for patients with cholangitis.
• To explore risk factors of cholangitis and outcomes in those patients

Detailed Description

Under physiological conditions, bile is sterile. Major factors maintaining sterility of bile are a competent sphincter of Oddi and antegrade flow of bile. Other factors are bile salts in the bile duct, Kupffer cells and tight junctions between the hepatocytes that guard against bacteria getting in from the portal circulation. Any break in these physiological barriers leads to infection of the bile. The main source of infection in most cases is the duodenum. Hematogenous spread through the portal venous flow is another route. In addition, bile duct obstruction e.g., stone, is associated with bacterial colonization within the stagnant bile and with increasing biliary pressure, bacteria may translocate into the circulation causing a systemic infection .

In patients without stone disease, previous biliary intervention is associated with high rates of infection. Bacteremia as a complication of biliary intervention tends to occur in patients with obstructed bile flow, especially those who have previously undergone orthotopic liver transplantation (OLT), surgery to the biliary tree, sphincterotomy, or placement of a biliary stent. The risk of systemic infection is high when adequate biliary drainage has not been achieved after intervention, which typically involves endoscopic retrograde cholangiopancreatography (ERCP) or percutaneous transhepatic cholangiography (PTC).

Acute cholangitis is acute inflammation and infection in the bile duct. It is diagnosed in 6-9% of patients with gallstone disease and 1-3% after ERCP. It can progress from a local biliary infection to advanced systemic disease with sepsis and multiple organ dysfunctions with significant mortality rates (10%).

Microbial infection causing acute cholangitis is mainly bacteria and fungi. Despite blood cultures provide an opportunity to detect the causative organism, they remain negative in more than half of the cases with cholangitis. The growth is often mono-microbial organism, predominantly Gram-negative organisms. However, bile cultures often have a poly-microbial growth especially in patients with an indwelling biliary stent where, Gram-negative bacteria, in particular Escherichia coli, are the most common pathogens isolated from infected bile.

The fungal infection of the biliary tract increase in the last years and can lead to biliary obstruction. The most common fungal infection in biliary tract is candidiasis.

Because of the rapid development of multi-drug resistant organisms, the choice of appropriate empiric antimicrobial therapy has become more complicated. Thus, knowledge of the common etiologic agents and their local susceptibility profile is essential to ensure the appropriate choice and timely administration of empiric antimicrobial therapy.

Conditions

Cholangitis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

bile culture

Bile samples will be collected for microbial cultures and antimicrobial susceptibility testing using COMPACT-15 automated system (Bio Merieux, Marcy I'Etoile, France) for bacteria and saboroud's agar for fungal culture.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Patients with extrahepatic cholestasis undergoing biliary procedure (ERCP or PTD) will be included.

Exclusion Criteria

• patients less than 18 years old.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Nourhan Mostafa Salama

Assistant Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Abeer Sharaf, AP

Role: STUDY_DIRECTOR

Assiut University

Locations

Assiut

Asyut, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Nourhan Mostafa

Role: CONTACT

nourhanmostafa314@gmail.com

01001668484

Elham Ahmed, AP

Role: CONTACT

mam_elham75@yahoo.com

01002963415

Facility Contacts

Nourhan M Mostafa, Resident

Role: primary

nourhanmostafa314@gmail.com

+201064999848 ext. 088

Other Identifiers

Microbial profile in bile

Identifier Type: -

Identifier Source: org_study_id