Results of Bile and Blood Culture in Patients With Acute Cholangitis

NCT02107560 | Terminated DMC

• 1 other identifier: SNUBH-IMGPB-2014-01
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cholangitis

Keywords

Cholangitis; Bacteremia; Endotoxemia; Blood; Bile

Outcome Measures

Primary Outcomes (1)

• Postive culture rates of blood and bile juice

  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

Secondary Outcomes (3)

• 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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

MeSH Terms

Conditions

Cholangitis; Bacteremia; Endotoxemia

Condition Hierarchy (Ancestors)

Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Toxemia

Study Officials

• Jaihwan Kim, M.D.

  Seoul National University Bundang Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2014
• First Posted: April 8, 2014
• Study Start: April 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: May 25, 2016

Record last verified: 2014-04

Locations

KR (1)