The Necessity of Bile Cultures in Patients With Acute Cholangitis

Study Overview
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Brief Summary
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Acute cholangitis with obstructive jaundice is a condition which needs biliary drainage and appropriate antibiotics. Bile culture is an optional laboratory test according to 2013 Tokyo guideline, but the clinical significance is yet unproven. And its results might indicate less information of the true pathogen regarding normal flora. Previous study conducted at our institute found drug-resistant pathogens identified in bile culture had no impact on the outcome. So the investigators are conducting a multicenter randomized controlled trial comparing groups which considers both blood and bile culture as control and which considers only blood culture as trial group in order to prove bile culture provides no additional helpful clinical information.

Detailed Description
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This study includes patients who are diagnosed acute cholangitis and had percutaneous transhepatic biliary drainage (PTBD) as the modality of biliary drainage. All patients will start empirical antibiotics as soon as they are diagnosed acute cholangitis. Randomization will be done after the blood sample and bile sample for culture are obtained. The patients will be allocated to one of the control or trial group. Patients in control group considers both blood and bile culture for the choice of antibiotics, and patients in trial group considers only blood culture for the choice of antibiotics. Organ failure and mortality rate are the primary outcomes. Data will be analyzed as intention-to-treat (ITT) and per-protocol (PP). The rate of organ failure and mortality will be analyzed by Pearson chi-square & Fisher exact test.

Official Title
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The Necessity of Bile Cultures in Patients With Acute Cholangitis

Conditions
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Acute Cholangitis

Intervention / Treatment
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* Other: Ignoring result of bile culture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed acute cholangitis (as 2013 Tokyo guideline) Percutaneous transhepatic biliary drainage Exclusion Criteria: Pre-existing organ failure Failure to obtain initial bile aspiration Failed PTBD Failure of full drainage via PTBD (all of the bile duct obstruction should be drained via PTBD) Organ failure from other causes

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Group which considers both blood culture and bile culture for antibiotics choice | |
| Experimental: Trial<br>Group which considers only blood culture and ignore bile culture for antibiotics choice. Patients in this arm would undergo bile culture but ignore the result when choosing antibiotics | Other: Ignoring result of bile culture<br>* Patients in the trial arm will do bile cultures which will not be considered when choosing antibiotics.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Organ Failure | Shock Systolic blood pressure under 90mmHg after adequate volume resuscitation Vassopressors or inotropics needed to maintain effective circulation Acute kidney injury (KDIGO 2012) Increase in SCr by >= 0.3mg/dl within 48 hours Increase in SCr to >= 1.5 times baseline, known or presumed within 7 days Urine volume < 0.5mg/kg/h for 6 hours Altered mentality Glasgow coma scale (GCS) < 12 or GCS score decrease > 3 Acute respiratory distress Pulse oxygen saturation < 90% Mechanical ventilation applied | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital days | The duration from random assignment to discharge is assessed in terms of days, and a 95% confidence interval is provided. The comparison of the length of stay between groups is conducted using the Student's t-test. | Expected average of 7 days | 
| Re-intervention for biliary drainage | Defined as the proportion of patients undergoing procedures for biliary drainage during the length of stay after random assignment and empirical antibiotic administration, along with a 95% confidence interval provided. The incidence of re-intervention frequency between each group is analyzed using Pearson χ2 with Fisher's exact test. | Expected average of 2 days | 
| Mortality | The English translation of the given Korean text is: To identify independent risk factors for mortality, a multivariate analysis using logistic regression is conducted, including all variables that are statistically significant in univariate analysis. All tests are two-sided, and a P-value less than 0.05 is considered statistically significant. | Participants will be followed for the duration of hospital stay, an expected average of 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cholangitis, Bile culture