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Microbial Analysis in Patients With Cholangitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04216745
Recruitment Status : Not yet recruiting
First Posted : January 3, 2020
Last Update Posted : January 7, 2020
Sponsor:
Information provided by (Responsible Party):
Nourhan Mostafa Salama, Assiut University

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

Condition or disease Intervention/treatment
Cholangitis Diagnostic Test: bile culture

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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Microbial Profile of Cholangitis in Patients Undergoing Biliary Intervention
Estimated Study Start Date : March 1, 2020
Estimated Primary Completion Date : March 30, 2021
Estimated Study Completion Date : May 30, 2021

Intervention Details:
  • Diagnostic Test: 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.


Primary Outcome Measures :
  1. Evaluation of the microbial profile of cholangitis [ Time Frame: Up to 24 weeks ]
    to evaluate the microbial profile of cholangitis regarding types of organisms


Secondary Outcome Measures :
  1. Evaluation of short-term mortality [ Time Frame: Up to 24 weeks ]
    follow up patients with cholangitis to evaluate short-term mortality rate (%)



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
- Patients with extrahepatic cholestasis undergoing biliary procedure (ERCP or PTD)
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • patients less than 18 years old.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04216745


Contacts
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Contact: Nourhan Mostafa 01001668484 nourhanmostafa314@gmail.com
Contact: Elham Ahmed, AP 01002963415 mam_elham75@yahoo.com

Sponsors and Collaborators
Assiut University
Investigators
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Study Director: Abeer Sharaf, AP Assiut University
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Responsible Party: Nourhan Mostafa Salama, Assistant Lecturer, Assiut University
ClinicalTrials.gov Identifier: NCT04216745    
Other Study ID Numbers: Microbial profile in bile
First Posted: January 3, 2020    Key Record Dates
Last Update Posted: January 7, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cholangitis
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases