The Necessity of Bile Cultures in Patients With Acute Cholangitis

Acute Cholangitis Clinical Trial

Official title: The Necessity of Bile Cultures in Patients With Acute Cholangitis

Status Active, not recruiting

Clinical Trial Summary

Acute cholangitis with obstructive jaundice is a condition which needs biliary drainage and appropriate antibiotics. Bile culture is an optional laboratory test according to 2013 Tokyo guideline, but the clinical significance is yet unproven. And its results might indicate less information of the true pathogen regarding normal flora. Previous study conducted at our institute found drug-resistant pathogens identified in bile culture had no impact on the outcome. So the investigators are conducting a multicenter randomized controlled trial comparing groups which considers both blood and bile culture as control and which considers only blood culture as trial group in order to prove bile culture provides no additional helpful clinical information.

Clinical Trial Description

This study includes patients who are diagnosed acute cholangitis and had percutaneous transhepatic biliary drainage (PTBD) as the modality of biliary drainage. All patients will start empirical antibiotics as soon as they are diagnosed acute cholangitis. Randomization will be done after the blood sample and bile sample for culture are obtained. This study was conducted as a single-blinded randomized clinical trial. Participants were randomly allocated to either the experimental or control group, with the allocation process concealed from the participants. Despite efforts to maintain rigor in the study design, it was not feasible to blind the physicians involved in the trial to the group assignments. This was due to inherent limitations in the research design, necessitating that they make clinical decisions for the selection of antibiotics based on the results of blood and/or bile culture studies. Patients in control group considers both blood and bile culture for the choice of antibiotics, and patients in trial group considers only blood culture for the choice of antibiotics. Organ failure rate is the primary outcomes. Data will be analyzed as intention-to-treat (ITT) and per-protocol (PP). The rate of organ failure and mortality will be analyzed by Pearson chi-square & Fisher exact test. ;

Related Conditions & MeSH terms

• Acute Cholangitis
• Cholangitis

• NCT number: NCT02601417
• Study type: Interventional
• Source: Seoul National University Hospital
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 27, 2015
• Completion date: February 14, 2024