Short Duration Versus Fourteen Days Antibiotic in Common Bile Duct Cholangitis

Common Bile Duct Calculi Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03422042
• Other study ID #: REC 56-124-21-1-2
• Status: Completed
• Phase: N/A
• Start date: August 13, 2017
• Est. completion date: August 30, 2019

Study information

• Verified date: November 2017
• Source: Prince of Songkla University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: August 30, 2019
• Est. primary completion date: February 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Cholangitis
• Calculi
• Cholangitis
• Common Bile Duct Calculi
• Gallstones

Intervention

Other:
• Short duration of antibiotic
Patient will received intravenous antibiotic until the body temperature is less than 37.8 c fir 72, then antibiotic is discontinued.
• Standard treatment of antibiotic
Patient will received intravenous antibiotic for 7 days, followed by oral antibiotic for 7 days, regardless of the body temperature.

Locations

Country	Name	City	State
Thailand	NKC Institue of Gastroenterology and Hepatology, Prince of Songkla University	Hatyai	Songkla

Sponsors (1)

Lead Sponsor	Collaborator
Prince of Songkla University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The recurrence rate of cholangitis	The number of patients who has recurrence of fever after complete treatment without other sources identified	8 weeks
Secondary	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.	24 hours
Secondary	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.	4 weeks
Secondary	Mortality rate	The number of patient with death	4 weeks