Acute Cholangitis, Common Bile Duct Calculi
Conditions
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.
Interventions
OTHERShort duration of antibiotic
Patient will received intravenous antibiotic until the body temperature is less than 37.8 c fir 72, then antibiotic is discontinued.
OTHERStandard treatment of antibiotic
Patient will received intravenous antibiotic for 7 days, followed by oral antibiotic for 7 days, regardless of the body temperature.
Sponsors
Prince of Songkla University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The recurrence rate of cholangitis | 8 weeks | The number of patients who has recurrence of fever after complete treatment without other sources identified |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The rate of adequacy of drainage | 24 hours | The number of patient with cholangiography at the end of the procedure showed no fill defect in the bile duct. |
| Complication rate | 4 weeks | 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. |
| Mortality rate | 4 weeks | The number of patient with death |
Countries
Thailand
Outcome results
None listed