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Results of Bile and Blood Culture in Patients With Acute Cholangitis

This study has been terminated.
(Because of small number of enrolled patients, we terminated this study.)
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT02107560
First received: April 3, 2014
Last updated: November 18, 2014
Last verified: April 2014
  Purpose

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.


Condition
Cholangitis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Comparison of Results With Bile and Blood Culture in Patients With Acute Cholangitis According to Severity

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Postive culture rates of blood and bile juice [ Time Frame: 1 week after culture test ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Identification of bacterial species in blood and bile cultures [ Time Frame: 1 week after culture test ] [ Designated as safety issue: No ]
    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.

  • Identification of antibiotics sensitive and resistant bacterial species [ Time Frame: 1 week after culture test ] [ Designated as safety issue: No ]
    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.

  • Identification of colonized bacterial species [ Time Frame: 1 week after culture test ] [ Designated as safety issue: No ]
    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.


Enrollment: 3
Study Start Date: April 2014
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02107560

Locations
Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Gyeonggi-do, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Study Chair: Jaihwan Kim, M.D. Seoul National University Bundang Hospital
  More Information

No publications provided

Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02107560     History of Changes
Other Study ID Numbers: SNUBH-IMGPB-2014-01
Study First Received: April 3, 2014
Last Updated: November 18, 2014
Health Authority: Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:
Cholangitis
Bacteremia
Endotoxemia
Blood
Bile

Additional relevant MeSH terms:
Cholangitis
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on November 25, 2014