An observational study in Cholangitis, sponsored by Seoul National University Hospital. Terminated at 1 site in Korea, Republic of. Per ClinicalTrials.gov, last updated 2016-05-25.
Sponsored by Seoul National University Hospital · Observational
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.
228 studies on the registry are indexed under Cholangitis; 32 are open to participants now.
This study's enrollment of 3 is below the median of 140 across 65 observational studies indexed under Cholangitis.
Browse Cholangitis studies →Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
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The patients who visited to tertiary medical center(Seoul National University Bundang Hospital) because of moderate or severe obstructive cholangitis
Exclusion Criteria:
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.
Time frame: 1 week after culture test
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.
Time frame: 1 week after culture test
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.
Time frame: 1 week after culture test
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.
Time frame: 1 week after culture test
This study is terminated, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.
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Seoul National University Hospital