Short Duration Versus Fourteen Days Antibiotic in Common Bile Duct Cholangitis

• ClinicalTrials.gov Identifier: NCT03422042
• Recruitment Status: Completed
• First Posted: February 5, 2018
• Last Update Posted: March 4, 2020
• Sponsor: Prince of Songkla University
• Information provided by (Responsible Party): Nisa Netinatsunton, Prince of Songkla University

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.

Condition or disease	Intervention/treatment	Phase
Acute Cholangitis; Common Bile Duct Calculi	Other: Short duration of antibiotic; Other: Standard treatment of antibiotic	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: August 13, 2017
• Actual Primary Completion Date: February 20, 2019
• Actual Study Completion Date: August 30, 2019

Arms and Interventions

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 Name: 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 Name: G2

Outcome Measures

Primary Outcome Measures :

1. The recurrence rate of cholangitis [ Time Frame: 8 weeks ]
   The number of patients who has recurrence of fever after complete treatment without other sources identified

Secondary Outcome Measures :

1. The rate of adequacy of drainage [ Time Frame: 24 hours ]
   The number of patient with cholangiography at the end of the procedure showed no fill defect in the bile duct.
2. Complication rate [ Time Frame: 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.
3. Mortality rate [ Time Frame: 4 weeks ]
   The number of patient with death

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Thailand

NKC Institue of Gastroenterology and Hepatology, Prince of Songkla University

Hatyai, Songkla, Thailand, 90110

Sponsors and Collaborators

Prince of Songkla University

Investigators

• Principal Investigator: Nisa Netinatsunton, MD.; NKC Institute of Gastroenterology and Hepatology.

More Information

• Responsible Party: Nisa Netinatsunton, Principal Investigator, Prince of Songkla University
• ClinicalTrials.gov Identifier: NCT03422042
• Other Study ID Numbers: REC 56-124-21-1-2
• First Posted: February 5, 2018
• Last Update Posted: March 4, 2020
• Last Verified: November 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• 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

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Cholangitis; Gallstones; Calculi; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Pathological Conditions, Anatomical; Cholelithiasis; Cholecystolithiasis; Gallbladder Diseases; Anti-Bacterial Agents; Antibiotics, Antitubercular; Anti-Infective Agents; Antitubercular Agents