The Necessity of Bile Cultures in Patients With Acute Cholangitis

NCT02601417 | Active Not Recruiting

• 1 other identifier: 2015-1452
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Cholangitis; Bile culture; percutaneous transhepatic biliary drainage

Outcome Measures

Primary Outcomes (1)

• Organ Failure

  Shock, AKI, altered mentality, Acute respiratory distress

  during hospitalization and empirical antibiotic administration. (From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months)

Secondary Outcomes (3)

• Hospital days

  through study completion, an average of 1 month

• Re-intervention for biliary drainage

  through study completion, an average of 1 month

• Mortality

  through study completion, an average of 1 month

Study Arms (2)

Antibiotics change is based on both blood and bile cultures

NO INTERVENTION

Empirical antibiotic therapy was initially conducted for patients. In the control group, the initial antibiotic regimen was maintained if both blood and bile cultures were negative or if all identified organisms were sensitive to empirical treatment. However, the empirical antibiotics were switched to appropriate antibiotics considering the results from blood and bile cultures if any organism demonstrated resistance. Following antibiotic modification in the experimental and control groups, additional biliary drainage procedures (ERCP or PTBD) were performed for considering ineffective drainage on the discretion of physicians.

Antibiotics change is based only on the blood culture

EXPERIMENTAL

Empirical antibiotic therapy was initially conducted for patients. In experimental group, 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. Following antibiotic modification in the experimental and control groups, additional biliary drainage procedures (ERCP or PTBD) were performed for considering ineffective drainage on the discretion of physicians.

Other: Ignoring result of bile culture

Interventions

Ignoring result of bile culture OTHER

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

Antibiotics change is based only on the blood culture

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (1) patients aged ≥20 years with suspected or confirmed acute cholangitis according to the 2013 and 2018 Tokyo guidelines

You may not qualify if:

• inability to provide informed consent
• no evidence of acute cholangitis diagnostics as per the guidelines
• development of organ failure before random allocation or organ failure by non-cholangitis causes
• undergoing bile culture tests after the onset of organ failure
• failure to have bile or blood culture tests
• patients who were already administered antibiotics for other conditions
• unsuccessful PTBD insertion
• failure to achieve complete bile drainage via PTBD

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Cholangitis

Condition Hierarchy (Ancestors)

Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases

Study Officials

• Sang Hyub Lee, MD. PhD.

  Department of internal medicine and liver research institute, Seoul national university hospital, Seoul, Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 27, 2015
• First Posted: November 10, 2015
• Study Start: August 27, 2015
• Primary Completion: March 20, 2024
• Study Completion: July 30, 2024
• Last Updated: May 30, 2024

Record last verified: 2024-05

Locations

KR (1)