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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Prince of Songkla University
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- The recurrence rate of cholangitis
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Short duration of antibiotic
group A: will received intravenous antibiotic until the temperature is less than 37.8 c for 72 hours, then antibiotic is discontinued
Intervention: Short duration of antibiotic (Other)
Standard treatment of antibiotic
group B: will received intravenous antibiotic for 7 days, and followed by oral antibiotic for 7 days, regardless of body temperature
Intervention: Standard treatment of antibiotic (Other)
Outcomes
Primary Outcomes
The recurrence rate of cholangitis
Time Frame: 8 weeks
The number of patients who has recurrence of fever after complete treatment without other sources identified
Secondary Outcomes
- Mortality rate(4 weeks)
- The rate of adequacy of drainage(24 hours)
- Complication rate(4 weeks)
Investigators
Nisa Netinatsunton
Principal Investigator
Prince of Songkla University