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临床试验/NCT02107560
NCT02107560终止不适用

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

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2014年4月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
3
试验地点
1
主要终点
Postive culture rates of blood and bile juice

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Postive culture rates of blood and bile juice

时间窗: 1 week after culture test

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.

次要结局

  • Identification of bacterial species in blood and bile cultures(1 week after culture test)
  • Identification of antibiotics sensitive and resistant bacterial species(1 week after culture test)
  • Identification of colonized bacterial species(1 week after culture test)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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