An interventional study of Short duration of antibiotic and Standard treatment of antibiotic in Acute Cholangitis and Common Bile Duct Calculi, sponsored by Prince of Songkla University. Completed at 1 site in Thailand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-04.
Sponsored by Prince of Songkla University · Not applicable, Interventional, and Treatment
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.
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.
354 studies on the registry are indexed under Gallstones; 47 are open to participants now.
This study's enrollment of 36 is below the median of 94 across 237 interventional studies indexed under Gallstones.
Browse Gallstones studies →Prince of Songkla University is the lead sponsor of 116 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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 until the body temperature is less than 37.8 c fir 72, then antibiotic is discontinued.
Also known as: G1
Patient will received intravenous antibiotic for 7 days, followed by oral antibiotic for 7 days, regardless of the body temperature.
Also known as: G2
The recurrence rate of cholangitis
The number of patients who has recurrence of fever after complete treatment without other sources identified
Time frame: 8 weeks
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.
Time frame: 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.
Time frame: 4 weeks
Mortality rate
The number of patient with death
Time frame: 4 weeks
Plan to share: No — 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
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Prince of Songkla University →