CholangitisNCT02107560
Results of Bile and Blood Culture in Patients With Acute Cholangitis
An observational study of Cholangitis, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cholangitis
- How many people
- 3 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2014to Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The patients who visited to tertiary medical center(Seoul National University Bundang Hospital) because of moderate or severe obstructive cholangitis
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
About this study
Official title: 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.
- Conditions
- Cholangitis
- Keywords
- Cholangitis, Bacteremia, Endotoxemia, Blood, Bile
- Medical subject headings
- Cholangitis, Bacteremia, Endotoxemia
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 week after culture test
Secondary outcomes (3)
Identification of bacterial species in blood and bile cultures
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.
Measured: 1 week after culture test
Identification of antibiotics sensitive and resistant bacterial species
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.
Measured: 1 week after culture test
Identification of colonized bacterial species
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.
Measured: 1 week after culture test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionMar 2016
- Study completionMar 2016
Why it stopped: Because of small number of enrolled patients, we terminated this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholangitisStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jaihwan Kim, M.D., Study chair, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02107560
- Sponsor's protocol ID
- SNUBH-IMGPB-2014-01
- Status last verified
- Apr 2014
- First submitted
- 3 Apr 2014
- Last updated
- 25 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Results With Bile and Blood Culture in Patients With Acute Cholangitis According to Severity
- ClinicalTrials.gov ID
- NCT02107560
- Acronym / sponsor ID
- SNUBH-IMGPB-2014-01
- Conditions
- Cholangitis
- Keywords
- Cholangitis, Bacteremia, Endotoxemia, Blood, Bile
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Because of small number of enrolled patients, we terminated this study.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 8 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The patients who visited to tertiary medical center(Seoul National University Bundang Hospital) because of moderate or severe obstructive cholangitis
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postive culture rates of blood and bile juice
Time frame: 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.
3 secondary outcomes
Identification of bacterial species in blood and bile cultures
Time frame: 1 week after culture test
Identification of antibiotics sensitive and resistant bacterial species
Time frame: 1 week after culture test
Identification of colonized bacterial species
Time frame: 1 week after culture test
Results and safety
The study was stopped early (reason given: Because of small number of enrolled patients, we terminated this study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2016.
Related trials for Cholangitis
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FIREFLY Trial: Fenofibrate Intervention---Randomized Evaluation in First-Line PBC Therapy
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Not yet recruitingPhase 4
Rifaximin for Prevention of Recurrent Mild-to-moderate Ascending Cholangitis After Biliary-enteric Anastomosis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaihwan Kim, M.D. study chair
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cholangitis, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Because of small number of enrolled patients, we terminated this study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postive culture rates of blood and bile juice (time frame: 1 week after culture test). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2016.