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NCT Number: NCT03422042

Short Duration Versus Fourteen Days Antibiotic in Common Bile Duct Cholangitis

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.

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Key information

Conditions

Acute Cholangitis Biliary Tract Diseases Calculi Cholecystolithiasis Cholelithiasis Common Bile Duct Calculi Digestive System Diseases Gallbladder Diseases Gallstones Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NKC Institue of Gastroenterology and Hepatology, Prince of Songkla University

Hat Yai, Changwat Songkhla, 90110, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Short duration of antibiotic

Other

Patient will received intravenous antibiotic until the body temperature is less than 37.8 c fir 72, then antibiotic is discontinued.

Other names: G1

Standard treatment of antibiotic

Other

Patient will received intravenous antibiotic for 7 days, followed by oral antibiotic for 7 days, regardless of the body temperature.

Other names: G2

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Prince of Songkla University

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Feb 5, 2018
Registry last updated
Mar 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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