The Necessity of Bile Cultures in Patients With Acute Cholangitis

• ClinicalTrials.gov Identifier: NCT02601417
• Recruitment Status: Unknown
• First Posted: November 10, 2015
• Last Update Posted: September 8, 2017
• Sponsor: Seoul National University Hospital
• Information provided by (Responsible Party): Sang Hyub Lee, Seoul National University Hospital

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.

Condition or disease	Intervention/treatment	Phase
Acute Cholangitis	Other: Ignoring result of bile culture	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 440 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: The Necessity of Bile Cultures in Patients With Acute Cholangitis
• Actual Study Start Date: August 27, 2015
• Estimated Primary Completion Date: August 2018
• Estimated Study Completion Date: February 2019

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Control; Group which considers both blood culture and bile culture for antibiotics choice
Experimental: Trial; 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	Other: Ignoring result of bile culture; Patients in the trial arm will do bile cultures which will not be considered when choosing antibiotics.

Outcome Measures

Primary Outcome Measures :

1. Organ Failure [ Time Frame: 48 hours ]

   1. Shock

      • Systolic blood pressure under 90mmHg after adequate volume resuscitation
      • Vassopressors or inotropics needed to maintain effective circulation

   2. 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

   3. Altered mentality

      • Glasgow coma scale (GCS) < 12
      • or GCS score decrease > 3

   4. Acute respiratory distress

      • Pulse oxygen saturation < 90%
      • Mechanical ventilation applied

Secondary Outcome Measures :

1. Hospital days [ Time Frame: Expected average of 7 days ]
2. Re-intervention for biliary drainage [ Time Frame: Expected average of 2 days ]
3. Mortality [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks ]

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Sang Hyub Lee, MD. PhD.; +82-2-2072-4892; gidoctor@snuh.org

Contact: Jae Woo Lee, MD.; +82-10-9411-6446; planeswalk6446@daum.net

Locations

Korea, Republic of

Seoul National University Hospital; Recruiting

Seoul, Korea, Republic of, 110-744

Contact: Sang Hyub Lee, MD. PhD. +82-2-2072-4892 gidoctor@snuh.org

Sponsors and Collaborators

Seoul National University Hospital

Investigators

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

More Information

• Responsible Party: Sang Hyub Lee, Associate Professor, Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT02601417 History of Changes
• Other Study ID Numbers: 2015-1452
• First Posted: November 10, 2015
• Last Update Posted: September 8, 2017
• Last Verified: September 2017

Keywords provided by Sang Hyub Lee, Seoul National University Hospital:

Cholangitis; Bile culture

Additional relevant MeSH terms:

Cholangitis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Anti-Bacterial Agents; Anti-Infective Agents