Microbial Analysis in Patients With Cholangitis

Microbial Profile of Cholangitis in Patients Undergoing Biliary Intervention

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

Study Overview

• Status: Unknown
• Conditions: Cholangitis
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Nourhan Mostafa; Phone Number: 01001668484; Email: nourhanmostafa314@gmail.com
• Study Contact Backup: Name: Elham Ahmed, AP; Phone Number: 01002963415; Email: mam_elham75@yahoo.com

Study Locations

• Egypt
  • Assiut, Egypt, 71515
    • Recruiting
    • Assiut
    • Contact: Nourhan M Mostafa, Resident; Phone Number: 088 +201064999848; Email: nourhanmostafa314@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

- Patients with extrahepatic cholestasis undergoing biliary procedure (ERCP or PTD)

Description

Inclusion Criteria:

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

Exclusion Criteria:

• patients less than 18 years old.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the microbial profile of cholangitis	to evaluate the microbial profile of cholangitis regarding types of organisms	Up to 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of short-term mortality	follow up patients with cholangitis to evaluate short-term mortality rate (%)	Up to 24 weeks

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Director: Abeer Sharaf, AP, Assiut University

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2020
• Primary Completion (ANTICIPATED): March 30, 2021
• Study Completion (ANTICIPATED): May 30, 2021

Study Registration Dates

• First Submitted: December 27, 2019
• First Submitted That Met QC Criteria: December 30, 2019
• First Posted (ACTUAL): January 3, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 13, 2021
• Last Update Submitted That Met QC Criteria: January 12, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Biliary Tract Diseases; Bile Duct Diseases; Cholangitis
• Other Study ID Numbers: Microbial profile in bile

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No