Short Duration Versus Fourteen Days Antibiotic in Common Bile Duct Cholangitis
Primary Purpose
Acute Cholangitis, Common Bile Duct Calculi
Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Short duration of antibiotic
Standard treatment of antibiotic
Sponsored by
About this trial
This is an interventional treatment trial for Acute Cholangitis
Eligibility Criteria
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
Sites / Locations
- NKC Institue of Gastroenterology and Hepatology, Prince of Songkla University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Short duration of antibiotic
Standard treatment of antibiotic
Arm Description
group A: will received intravenous antibiotic until the temperature is less than 37.8 c for 72 hours, then antibiotic is discontinued
group B: will received intravenous antibiotic for 7 days, and followed by oral antibiotic for 7 days, regardless of body temperature
Outcomes
Primary Outcome Measures
The recurrence rate of cholangitis
The number of patients who has recurrence of fever after complete treatment without other sources identified
Secondary Outcome Measures
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.
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.
Mortality rate
The number of patient with death
Full Information
NCT ID
NCT03422042
First Posted
January 30, 2018
Last Updated
March 2, 2020
Sponsor
Prince of Songkla University
1. Study Identification
Unique Protocol Identification Number
NCT03422042
Brief Title
Short Duration Versus Fourteen Days Antibiotic in Common Bile Duct Cholangitis
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
August 13, 2017 (Actual)
Primary Completion Date
February 20, 2019 (Actual)
Study Completion Date
August 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Prince of Songkla University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Cholangitis, Common Bile Duct Calculi
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Short duration of antibiotic
Arm Type
Active Comparator
Arm Description
group A: will received intravenous antibiotic until the temperature is less than 37.8 c for 72 hours, then antibiotic is discontinued
Arm Title
Standard treatment of antibiotic
Arm Type
Active Comparator
Arm Description
group B: will received intravenous antibiotic for 7 days, and followed by oral antibiotic for 7 days, regardless of body temperature
Intervention Type
Other
Intervention Name(s)
Short duration of antibiotic
Other Intervention Name(s)
G1
Intervention Description
Patient will received intravenous antibiotic until the body temperature is less than 37.8 c fir 72, then antibiotic is discontinued.
Intervention Type
Other
Intervention Name(s)
Standard treatment of antibiotic
Other Intervention Name(s)
G2
Intervention Description
Patient will received intravenous antibiotic for 7 days, followed by oral antibiotic for 7 days, regardless of the body temperature.
Primary Outcome Measure Information:
Title
The recurrence rate of cholangitis
Description
The number of patients who has recurrence of fever after complete treatment without other sources identified
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
The rate of adequacy of drainage
Description
The number of patient with cholangiography at the end of the procedure showed no fill defect in the bile duct.
Time Frame
24 hours
Title
Complication rate
Description
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
Title
Mortality rate
Description
The number of patient with death
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nisa Netinatsunton, MD.
Organizational Affiliation
NKC Institute of Gastroenterology and Hepatology.
Official's Role
Principal Investigator
Facility Information:
Facility Name
NKC Institue of Gastroenterology and Hepatology, Prince of Songkla University
City
Hatyai
State/Province
Songkla
ZIP/Postal Code
90110
Country
Thailand
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing 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
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Short Duration Versus Fourteen Days Antibiotic in Common Bile Duct Cholangitis
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