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CholangitisNCT04216745

Microbial Analysis in Patients With Cholangitis

An observational study of Cholangitis, run by Assiut University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Cholangitis
What is being tested?
bile culture
How many people
100 participants
Where
1 siteEgypt
Study dates
1 Mar 2020to 30 May 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • patients less than 18 years old.

Trial locations and contacts

1 site in 1 country.

Egypt1 site, 1 recruiting
  • Assiut

    Asyut, 71515

    Nourhan M Mostafa, Resident, +201064999848 ext. 088, nourhanmostafa314@gmail.com

    Recruiting

Other trials in Egypt

About this study

Official title: 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
Read the 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
Being tested
bile culture
Medical subject headings
Cholangitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bile cultureDiagnostic test

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluation of the microbial profile of cholangitis

    to evaluate the microbial profile of cholangitis regarding types of organisms

    Measured: Up to 24 weeks

Secondary outcomes (1)
  1. Evaluation of short-term mortality

    follow up patients with cholangitis to evaluate short-term mortality rate (%)

    Measured: Up to 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jan 2020
  2. Study start1 Mar 2020
  3. Primary completion30 Mar 2021 (estimated)
  4. Study completion30 May 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04216745
Sponsor's protocol ID
Microbial profile in bile
Status last verified
Jan 2021
First submitted
27 Dec 2019
Last updated
13 Jan 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Cholangitis, run by Assiut University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Nourhan Mostafa (01001668484, nourhanmostafa314@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of the microbial profile of cholangitis (time frame: Up to 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2021.

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