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The Necessity of Bile Cultures in Patients With Acute Cholangitis

Primary Purpose

Acute Cholangitis

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ignoring result of bile culture
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Cholangitis focused on measuring Cholangitis, Bile culture

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosed acute cholangitis (as 2013 Tokyo guideline)
  • Percutaneous transhepatic biliary drainage

Exclusion Criteria:

  • Pre-existing organ failure
  • Failure to obtain initial bile aspiration
  • Failed PTBD
  • Failure of full drainage via PTBD (all of the bile duct obstruction should be drained via PTBD)
  • Organ failure from other causes

Sites / Locations

  • Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Trial

Arm Description

Group which considers both blood culture and bile culture for antibiotics choice

Group which considers only blood culture and ignore bile culture for antibiotics choice. Patients in this arm would undergo bile culture but ignore the result when choosing antibiotics

Outcomes

Primary Outcome Measures

Organ Failure
Shock Systolic blood pressure under 90mmHg after adequate volume resuscitation Vassopressors or inotropics needed to maintain effective circulation Acute kidney injury (KDIGO 2012) Increase in SCr by >= 0.3mg/dl within 48 hours Increase in SCr to >= 1.5 times baseline, known or presumed within 7 days Urine volume < 0.5mg/kg/h for 6 hours Altered mentality Glasgow coma scale (GCS) < 12 or GCS score decrease > 3 Acute respiratory distress Pulse oxygen saturation < 90% Mechanical ventilation applied

Secondary Outcome Measures

Hospital days
Re-intervention for biliary drainage
Mortality

Full Information

First Posted
August 27, 2015
Last Updated
September 5, 2017
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02601417
Brief Title
The Necessity of Bile Cultures in Patients With Acute Cholangitis
Official Title
The Necessity of Bile Cultures in Patients With Acute Cholangitis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 27, 2015 (Actual)
Primary Completion Date
August 2018 (Anticipated)
Study Completion Date
February 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.
Detailed 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. The patients will be allocated to one of the control or trial group. 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 and mortality rate are 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Cholangitis
Keywords
Cholangitis, Bile culture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
440 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Group which considers both blood culture and bile culture for antibiotics choice
Arm Title
Trial
Arm Type
Experimental
Arm Description
Group which considers only blood culture and ignore bile culture for antibiotics choice. Patients in this arm would undergo bile culture but ignore the result when choosing antibiotics
Intervention Type
Other
Intervention Name(s)
Ignoring result of bile culture
Intervention Description
Patients in the trial arm will do bile cultures which will not be considered when choosing antibiotics.
Primary Outcome Measure Information:
Title
Organ Failure
Description
Shock Systolic blood pressure under 90mmHg after adequate volume resuscitation Vassopressors or inotropics needed to maintain effective circulation Acute kidney injury (KDIGO 2012) Increase in SCr by >= 0.3mg/dl within 48 hours Increase in SCr to >= 1.5 times baseline, known or presumed within 7 days Urine volume < 0.5mg/kg/h for 6 hours Altered mentality Glasgow coma scale (GCS) < 12 or GCS score decrease > 3 Acute respiratory distress Pulse oxygen saturation < 90% Mechanical ventilation applied
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Hospital days
Time Frame
Expected average of 7 days
Title
Re-intervention for biliary drainage
Time Frame
Expected average of 2 days
Title
Mortality
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed acute cholangitis (as 2013 Tokyo guideline) Percutaneous transhepatic biliary drainage Exclusion Criteria: Pre-existing organ failure Failure to obtain initial bile aspiration Failed PTBD Failure of full drainage via PTBD (all of the bile duct obstruction should be drained via PTBD) Organ failure from other causes
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sang Hyub Lee, MD. PhD.
Phone
+82-2-2072-4892
Email
gidoctor@snuh.org
First Name & Middle Initial & Last Name or Official Title & Degree
Jae Woo Lee, MD.
Phone
+82-10-9411-6446
Email
planeswalk6446@daum.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sang Hyub Lee, MD. PhD.
Organizational Affiliation
Department of internal medicine and liver research institute, Seoul national university hospital, Seoul, Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sang Hyub Lee, MD. PhD.
Phone
+82-2-2072-4892
Email
gidoctor@snuh.org

12. IPD Sharing Statement

Learn more about this trial

The Necessity of Bile Cultures in Patients With Acute Cholangitis

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