Short Duration Versus Fourteen Days Antibiotic in Common Bile Duct Cholangitis

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

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.

Study Overview

• Status: Completed
• Conditions: Common Bile Duct Calculi; Acute Cholangitis
• Intervention / Treatment: Other: Short duration of antibiotic; Other: Standard treatment of antibiotic

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 Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Songkla
    • Hatyai, Songkla, Thailand, 90110
      • NKC Institue of Gastroenterology and Hepatology, Prince of Songkla University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	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.; Other Names: G1
Active Comparator: 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	Other: Standard treatment of antibiotic; Patient will received intravenous antibiotic for 7 days, followed by oral antibiotic for 7 days, regardless of the body temperature.; Other Names: G2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The recurrence rate of cholangitis	The number of patients who has recurrence of fever after complete treatment without other sources identified	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Mortality rate	The number of patient with death	4 weeks

Collaborators and Investigators

• Sponsor: Prince of Songkla University
• Investigators: Principal Investigator: Nisa Netinatsunton, MD., NKC Institute of Gastroenterology and Hepatology.

Study record dates

Study Major Dates

• Study Start (Actual): August 13, 2017
• Primary Completion (Actual): February 20, 2019
• Study Completion (Actual): August 30, 2019

Study Registration Dates

• First Submitted: January 30, 2018
• First Submitted That Met QC Criteria: January 30, 2018
• First Posted (Actual): February 5, 2018

Study Record Updates

• Last Update Posted (Actual): March 4, 2020
• Last Update Submitted That Met QC Criteria: March 2, 2020
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathological Conditions, Anatomical; Gallbladder Diseases; Biliary Tract Diseases; Bile Duct Diseases; Cholelithiasis; Cholecystolithiasis; Calculi; Cholangitis; Gallstones; Anti-Infective Agents; Antitubercular Agents; Anti-Bacterial Agents; Antibiotics, Antitubercular
• Other Study ID Numbers: REC 56-124-21-1-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: The individual data of patients participating in the study are not available for public sharing since the investigators did not obtain the consent to share the data of patient

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No