Results of Bile and Blood Culture in Patients With Acute Cholangitis

Cholangitis Clinical Trial

Official title:

A Comparison of Results With Bile and Blood Culture in Patients With Acute Cholangitis According to Severity

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02107560
• Other study ID #: SNUBH-IMGPB-2014-01
• Status: Terminated
• Phase: N/A
• First received: April 3, 2014
• Last updated: May 23, 2016
• Start date: April 2014
• Est. completion date: March 2016

Study information

• Verified date: April 2014
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Cholangitis is a complication of biliary statsis. Bile juice is sterile when there is no obstruction, however, it can be infected with bacteria when there is a stasis or obstruction. After infection, cholangitis can be developed because of systematic endotoxemia or bacteremia. Though identification of bacteria is very important for selection of adequate antibiotics, treatment with empirical antibiotics is commonly performed when identification of bacteria is not possible.

Identification of bacteria is usually done with blood or bile culture. In the previous studies, the same results from blood and bile were common in patients with cholangitis. However, the data of these studies were based on the bile juice which was aspirated by surgery. Considering that bile duct obstruction is usually treated with endoscopy or radiological intervention without surgery, it is necessary to collect data with endoscopic or radiologic intervention. In addition, the concordant rate of these two tests has not been reported according to severity of cholangitis. As a result, the necessities of bile and blood culture are not agreed among experts in this fields.

Our hypothesis is that concordant rates of bile and blood culture are same in patients with each moderate or severe cholangitis. However, the concordant rates of bile and blood culture are different between patients with moderate and severe cholangitis. This study will assess the positive rates of blood and bile culture in patients with moderate or severe cholangitis, respectively and compare the results according to the different severity.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients with moderate or severe cholangitis which fullfilled the criteria by the Tokyo Guidelines (Tanaka A, Takada T, Kawarada Y, et al. Antimicrobial therapy for acute cholangitis: Tokyo Guidelines. J Hepatobiliary Pancreat Surg 2007;14:59-67.)

• Patients who are successfully treated with endoscopic or radiologic biliary drainage

• Patients who undergo both blood and bile culture tests

Exclusion Criteria:

• Patients with other infections except cholangitis or cholecystitis

• Patients who received surgical biliary drainage treatment

• Patients who are treated with endoscopic or radiologic biliary drainage more than 24 hours after using initial antibiotics

• Patients who does not agree with informed consent or who are vulnerable subjects

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cholangitis

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postive culture rates of blood and bile juice	Cultures results of blood and bile juice in patients with cholangitis are usually reported within 1 week after test in our hospital. After the completion of study, we will analyze the positive culture rates in each samples and compate those each other. In addition, we will compare the results according to the severity of cholangitis.	1 week after culture test	No
Secondary	Identification of bacterial species in blood and bile cultures	Cultures results of blood and bile juice in patients with cholangitis are usually reported within 1 week after test in our hospital. After the completion of study, we will analyze the bacterial species in each samples and compate those each other.	1 week after culture test	No
Secondary	Identification of antibiotics sensitive and resistant bacterial species	Cultures results of blood and bile juice in patients with cholangitis are usually reported within 1 week after test in our hospital. After the completion of study, we will analyze the antibiotics sensitive and resistant bacterial species in each samples and compate those each other.	1 week after culture test	No
Secondary	Identification of colonized bacterial species	Cultures results of blood and bile juice in patients with cholangitis are usually reported within 1 week after test in our hospital. After the completion of study, we will analyze the colonized bacterial species which is not true pathogens in each samples and compate those each other.	1 week after culture test	No