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Results of Bile and Blood Culture in Patients With Acute Cholangitis

23. mai 2016 oppdatert av: Seoul National University Hospital

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.

Studieoversikt

Status

Avsluttet

Forhold

Kolangitt

Studietype

Observasjonsmessig

Registrering (Faktiske)

Kontakter og plasseringer

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Studiesteder

Korea, Republikken
- Gyeonggi-do
  - Seongnam, Gyeonggi-do, Korea, Republikken, 463-707
    - Seoul National University Bundang Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

Barn
Voksen
Eldre voksen

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

The patients who visited to tertiary medical center(Seoul National University Bundang Hospital) because of moderate or severe obstructive cholangitis

Beskrivelse

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

Studieplan

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Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Postive culture rates of blood and bile juice Tidsramme: 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.	1 week after culture test

Sekundære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Identification of bacterial species in blood and bile cultures Tidsramme: 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 bacterial species in each samples and compate those each other.	1 week after culture test
Identification of antibiotics sensitive and resistant bacterial species Tidsramme: 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 antibiotics sensitive and resistant bacterial species in each samples and compate those each other.	1 week after culture test
Identification of colonized bacterial species Tidsramme: 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 colonized bacterial species which is not true pathogens in each samples and compate those each other.	1 week after culture test

Samarbeidspartnere og etterforskere

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Sponsor

Seoul National University Hospital

Etterforskere

Studiestol: Jaihwan Kim, M.D., Seoul National University Bundang Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. april 2014

Primær fullføring (Faktiske)

1. mars 2016

Studiet fullført (Faktiske)