Short Duration Versus Fourteen Days Antibiotic in Common Bile Duct Cholangitis

Prince of Songkla University

Status: Completed

Conditions: Acute Cholangitis; Common Bile Duct Calculi

Treatments: Other: Standard treatment of antibiotic; Other: Short duration of antibiotic

Study type: Interventional

Funder types: Other

Identifiers

NCT03422042

REC 56-124-21-1-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Short duration of antibiotic

Active Comparator group

Description:

group A: will received intravenous antibiotic until the temperature is less than 37.8 c for 72 hours, then antibiotic is discontinued

Treatment:

Other: Short duration of antibiotic

Standard treatment of antibiotic

Active Comparator group

Description:

group B: will received intravenous antibiotic for 7 days, and followed by oral antibiotic for 7 days, regardless of body temperature

Treatment:

Other: Standard treatment of antibiotic