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Short Duration Versus Fourteen Days Antibiotic in Common Bile Duct Cholangitis

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ClinicalTrials.gov Identifier: NCT03422042
Recruitment Status : Recruiting
First Posted : February 5, 2018
Last Update Posted : February 7, 2018
Sponsor:
Information provided by (Responsible Party):
Nisa Netinatsunton, 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.

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 92 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 : February 13, 2013
Estimated Primary Completion Date : February 20, 2019
Estimated Study Completion Date : November 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

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




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



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03422042


Contacts
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Contact: Nisa Netinatsunton, MD. 6674451965 ext 9 nisasan@yahoo.com
Contact: Bancha Ovartlarnporn, MD. 6674451965 ext 9 obancha@live.com

Locations
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Thailand
NKC Institue of Gastroenterology and Hepatology, Prince of Songkla University Recruiting
Hatyai, Songkla, Thailand, 90110
Contact: Dr. Nisa Netinatsunton, MD    8874451965 ext 9    nisasan@yahoo.com   
Contact: Dr.Bancha Ovartalaporn, MD    8874451965 ext 9    mrovartji-net@hotmail.com   
Principal Investigator: Nisa Netinatsunton, MD         
Sponsors and Collaborators
Prince of Songkla University
Investigators
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Principal Investigator: Nisa Netinatsunton, MD. NKC Institute of Gastroenterology and Hepatology, Faculty of Medicine, Prince of Songkla University, Hatyai, Songkhla, Thailand, 90110.

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Responsible Party: Nisa Netinatsunton, Principal Investigator, Prince of Songkla University
ClinicalTrials.gov Identifier: NCT03422042     History of Changes
Other Study ID Numbers: REC 56-124-21-1-2
First Posted: February 5, 2018    Key Record Dates
Last Update Posted: February 7, 2018
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

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

Additional relevant MeSH terms:
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Cholangitis
Calculi
Gallstones
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