- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02107560
Results of Bile and Blood Culture in Patients With Acute Cholangitis
A Comparison of Results With Bile and Blood Culture in Patients With Acute Cholangitis According to Severity
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.
Visão geral do estudo
Status
Condições
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Gyeonggi-do
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Seongnam, Gyeonggi-do, Republica da Coréia, 463-707
- Seoul National University Bundang Hospital
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Postive culture rates of blood and bile juice
Prazo: 1 week after culture test
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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.
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1 week after culture test
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Identification of bacterial species in blood and bile cultures
Prazo: 1 week after culture test
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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.
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1 week after culture test
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Identification of antibiotics sensitive and resistant bacterial species
Prazo: 1 week after culture test
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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.
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1 week after culture test
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Identification of colonized bacterial species
Prazo: 1 week after culture test
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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.
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1 week after culture test
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Cadeira de estudo: Jaihwan Kim, M.D., Seoul National University Bundang Hospital
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- SNUBH-IMGPB-2014-01
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