Short Duration Versus Fourteen Days Antibiotic in Common Bile Duct Cholangitis

Not Applicable

Completed

• Conditions: Acute Cholangitis; Common Bile Duct Calculi
• Interventions: Other: Standard treatment of antibiotic; Other: Short duration of antibiotic

• Registration Number: NCT03422042
• Lead Sponsor: Prince of Songkla University

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 Timeline

• Study Start: 2017-08-13
• Status Verified: 2017-11
• Study First Submitted: 2018-01-30
• Study First Submitted QC: 2018-01-30
• Study First Posted: 2018-02-05
• Primary Completion: 2019-02-20
• Study Completion: 2019-08-30
• Last Update Submitted: 2020-03-02
• Last Update Posted: 2020-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard treatment of antibiotic	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
Short duration of antibiotic	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

Primary Outcome Measures

Name	Time	Method
The recurrence rate of cholangitis	8 weeks	The number of patients who has recurrence of fever after complete treatment without other sources identified

Secondary Outcome Measures

Name	Time	Method
Mortality rate	4 weeks	The number of patient with death
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.

Trial Locations

Locations (1)

NKC Institue of Gastroenterology and Hepatology, Prince of Songkla University; 🇹🇭 Hatyai, Songkla, Thailand