- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo 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.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Gyeonggi-do
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Seongnam, Gyeonggi-do, Corea, república de, 463-707
- Seoul National University Bundang Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Postive culture rates of blood and bile juice
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Identification of bacterial species in blood and bile cultures
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
- Silla de estudio: Jaihwan Kim, M.D., Seoul National University Bundang Hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- SNUBH-IMGPB-2014-01
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