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Antibiotics to Decrease Post ERCP Cholangitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03087656
Recruitment Status : Recruiting
First Posted : March 22, 2017
Last Update Posted : May 22, 2019
Information provided by (Responsible Party):
James Buxbaum, University of Southern California

Brief Summary:

Endoscopic retrograde cholangiopancreatography (ERCP) is an endoscopic procedure used to treat bile duct stones, obstructive jaundice, biliary leaks, and a variety of other conditions.

There is active debate whether antibiotics should be given prophylactically for ERCP outside of high risk indications including primary sclerosing cholangitis. In part this is due to a lack of appropriately powered clinical trials with adequate follow up. The aim will be to assess whether prophylactic antibiotics decrease the rate of post ERCP cholangitis as defined by the Revised Tokyo Criterion.

Condition or disease Intervention/treatment Phase
Cholangitis Drug: Ceftriaxone Drug: Levofloxacin Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: subjects to be randomized into two arms: antibiotic arm and no antibiotic arm
Primary Purpose: Treatment
Official Title: Randomized Trial of Short Antibiotic Course to Decrease Post ERCP Cholangitis
Actual Study Start Date : March 29, 2017
Estimated Primary Completion Date : February 23, 2021
Estimated Study Completion Date : February 23, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Active Comparator: Antibiotic arm
The drugs ceftriaxone and levofloxacin will be administered to patients in the antibiotic arm.
Drug: Ceftriaxone
Intravenous Ceftriaxone will be given during the procedure.
Other Name: Rocephin

Drug: Levofloxacin
Oral Levofloxacin will be given for 3 days after the procedure.
Other Name: Levaquin

No Intervention: No Antibiotic arm
No prophylactic antibiotics will be administered.

Primary Outcome Measures :
  1. Proportion of patients who develop Post-ERCP Cholangitis as defined by the revised Tokyo criterion. [ Time Frame: 1 week ]
    The primary outcome will be the proportion of patients who develop develop post-ERCP cholangitis as defined by the Revised Tokyo criterion within 1 week of ERCP.

Secondary Outcome Measures :
  1. Days of hospitalization [ Time Frame: 1 week ]
    The number of days of hospitalization following ERCP will be compared among the two groups.

  2. Proportion of patients who develop adverse events of antibiotics [ Time Frame: 1 week ]
    The proportion of patients in the two groups who develop allergic reactions, C. difficile colitis, and other adverse symptoms attributable to antibiotic use will be compared.

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients aged 18 to 90 years undergoing therapeutic ERCP for standard, biliary indications including but not limited to:

    • suspected bile duct stones
    • malignant and benign biliary obstruction
    • bile leaks

Exclusion Criteria:

  • Patients who are incarcerated
  • Patients who are not competent to give informed consent
  • Patients in whom periprocedural antibiotics are mandatory.
  • These include patients with:

    • primary sclerosing cholangitis,
    • multiple biliary strictures,
    • hilar tumors,
    • neutropenia (absolute neutrophil count <500), or
    • immunosuppressive therapy.
  • Patients who have been diagnosed with cholangitis or are suspected to have another active infection requiring antibiotics (such as an infected fluid collection).
  • Patients who have received antibiotics within 7 days.
  • Patient who have undergone ERCP within 30 days.
  • Patients who undergo multiple ERCP for clinical indication will only be eligible to participate in the study for one procedure.
  • Patients who have had prior biliary surgeries.
  • Patients in whom bile duct decompression is unsuccessful will be excluded as these patients are at increased risk of cholangitis.
  • Patients with immediate procedural complications such as a bowel perforation.
  • Patients undergoing ERCP for diagnostic purposes only will be excluded as the aim is to study the role of antibiotics in those undergoing therapeutic ERCP.
  • Pregnant women
  • Patient with allergies to cephalosporins, fluoroquinolones, or penicillins.
  • Patients with renal insufficiency (creatinine clearance <80ml50ml/minute), in whom dose modifications are necessary.

Withdrawal Criteria:

  • Patients who withdraw consent will be withdrawn from the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03087656

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Contact: James Buxbaum 323 409 5371

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United States, California
Los Angeles County Hospital Recruiting
Los Angeles, California, United States, 90033
Contact: James Buxbaum, MD    323-409-5371   
Contact: Maria Trujillo    323 409 6939   
Sponsors and Collaborators
University of Southern California
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Principal Investigator: James Buxbaum University of Southern California Health Science Center
Publications of Results:

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Responsible Party: James Buxbaum, Chief Endoscopist/Associate Professor of Clinical Medicine, University of Southern California Identifier: NCT03087656    
Other Study ID Numbers: HS-16-00880
First Posted: March 22, 2017    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by James Buxbaum, University of Southern California:
Additional relevant MeSH terms:
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Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Anti-Bacterial Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors