Clinical trial NCT02107560: Results of Bile and Blood Culture in Patients With Acute Cholangitis
Official title: A Comparison of Results With Bile and Blood Culture in Patients With Acute Cholangitis According to Severity
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cholangitis
Keywords: Cholangitis
Bacteremia
Endotoxemia
Blood
Bile
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2014-04-08
Enrollment: 3
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients who visited to tertiary medical center(Seoul National University Bundang Hospital) because of moderate or severe obstructive cholangitis

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Postive culture rates of blood and bile juice
timeFrame: 1 week after culture test
Secondary outcomes:
measure: Identification of bacterial species in blood and bile cultures
timeFrame: 1 week after culture test
measure: Identification of antibiotics sensitive and resistant bacterial species
timeFrame: 1 week after culture test
measure: Identification of colonized bacterial species
timeFrame: 1 week after culture test
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Jaihwan Kim, M.D.
role: STUDY_CHAIR
References: