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The Necessity of Bile Cultures in Patients With Acute Cholangitis

NCT02601417 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 440

Last updated 2024-05-30

No results posted yet for this study

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, 2018 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.

Conditions

  • Acute Cholangitis

Interventions

OTHER

Ignoring result of bile culture

the antibiotic therapy was modified based only on the blood culture findings, where the blood cultures revealed insensitive organisms with the resistance to empirical antibiotics. The bile specimens from these patients were also obtained and cultured, but their results were not considered in the decision-making for antibiotic selection in the experimental group

Sponsors & Collaborators

  • Seoul National University Hospital

    lead OTHER

Principal Investigators

  • Sang Hyub Lee, MD. PhD. · Department of internal medicine and liver research institute, Seoul national university hospital, Seoul, Korea

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-27
Primary Completion
2024-03-20
Completion
2024-07-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02601417 on ClinicalTrials.gov