Short Duration Versus Fourteen Days Antibiotic in Common Bile Duct Cholangitis

N/ACompletedNCT03422042

Prince of Songkla University36 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute Cholangitis Common Bile Duct Calculi

Interventions

Short duration of antibioticOTHER

Patient will received intravenous antibiotic until the body temperature is less than 37.8 c fir 72, then antibiotic is discontinued.

Standard treatment of antibioticOTHER

Patient will received intravenous antibiotic for 7 days, followed by oral antibiotic for 7 days, regardless of the body temperature.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

NKC Institue of Gastroenterology and Hepatology, Prince of Songkla University

Hat Yai, Changwat Songkhla, Thailand

Outcomes

Primary Outcomes

The recurrence rate of cholangitis

The number of patients who has recurrence of fever after complete treatment without other sources identified

Time frame: 8 weeks

Secondary Outcomes

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.

Time frame: 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.

Time frame: 4 weeks

Mortality rate

The number of patient with death

Time frame: 4 weeks

Data from ClinicalTrials.gov

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