Short Duration Versus Fourteen Days Antibiotic in Common Bile Duct Cholangitis

Study Overview
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Brief Summary
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Common bile duct stone cholangitis is a potentially fatal condition, characterized by an obstruction and bacterial infection of biliary system. The principles of management are appropriate biliary drainage and systemic antibiotics. There has been limited data about appropriate time of antibiotics in patient with successful endoscopic drainage.

Detailed Description
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The aim is comparing the efficacy and safety between short duration and standard fourteen days antibiotic treatment in patients with acute common bile duct stone (CBDS) cholangitis after successful endoscopic biliary drainage as regards recurrence rate of acute cholangitis, complete stone clearance rate, morbidity and mortality associated acute cholangitis, and complications related ERCP procedure. The study will be divided patients with acute CBDS cholangitis with complete stone clearance into 2 groups, group (A) will be received intravenous antibiotic until the temperature is less than 37.8 c for 72 hours and group (B) will be received intravenous antibiotic for 7 days, followed by oral antibiotic for 7 days, regardless of the body temperature.

Official Title
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An Open-labeled, Randomized Controlled Trial Comparing Between Short Duration And Standard Fourteen Days Antibiotic Treatments In Patients With Acute Common Bile Duct Stone Cholangitis After Successful Endoscopic Biliary Drainage

Conditions
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Acute Cholangitis, Common Bile Duct Calculi

Intervention / Treatment
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* Other: Short duration of antibiotic
* Other: Standard treatment of antibiotic


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age ≥ 18 years old diagnosis of acute mild to moderate severity of ascending common bile duct stone cholangitis endoscopic retrograde cholangiopancreatography (ERCP) with biliary drainage within 72 hours after admission Exclusion Criteria: pregnant woman the cause of obstruction other than common bile duct stone severe co-morbid diseases such as cardiovascular/pulmonary/kidney disease active concomitant infections of other organs history of allergy to cephalosporin group

Ages Eligible for Study
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Minimum Age: 18 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Short duration of antibiotic<br>group A: will received intravenous antibiotic until the temperature is less than 37.8 c for 72 hours, then antibiotic is discontinued | Other: Short duration of antibiotic<br>* Patient will received intravenous antibiotic until the body temperature is less than 37.8 c fir 72, then antibiotic is discontinued.<br>* Other names: G1;|
| Active Comparator: Standard treatment of antibiotic<br>group B: will received intravenous antibiotic for 7 days, and followed by oral antibiotic for 7 days, regardless of body temperature | Other: Standard treatment of antibiotic<br>* Patient will received intravenous antibiotic for 7 days, followed by oral antibiotic for 7 days, regardless of the body temperature.<br>* Other names: G2;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The recurrence rate of cholangitis | The number of patients who has recurrence of fever after complete treatment without other sources identified | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of adequacy of drainage | The number of patient with cholangiography at the end of the procedure showed no fill defect in the bile duct. | 24 hours | 
| Complication rate | The number of patients who developed complications related procedure included pancreatitis, bleeding, perforation, cholangitis as defined and graded according to the consensus guideline and sedation related complications. | 4 weeks | 
| Mortality rate | The number of patient with death | 4 weeks |