RECRUITING

Antibiotics to Decrease Post ERCP Cholangitis

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Conditions

CholangitislevofloxacinCeftriaxoneERCP

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Randomized Trial of Short Antibiotic Course to Decrease Post ERCP Cholangitis

Quick Facts

Study Start:2017-03-29
Study Completion:2024-02-23
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03087656

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 90 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients aged 18 to 90 years undergoing therapeutic ERCP for standard, biliary indications including but not limited to:
  2. * suspected bile duct stones
  3. * malignant and benign biliary obstruction
  4. * bile leaks
  1. * Patients who are incarcerated
  2. * Patients who are not competent to give informed consent
  3. * Patients in whom periprocedural antibiotics are mandatory.
  4. * These include patients with:
  5. * primary sclerosing cholangitis,
  6. * multiple biliary strictures,
  7. * hilar tumors,
  8. * neutropenia (absolute neutrophil count \<500), or
  9. * immunosuppressive therapy.
  10. * Patients who have been diagnosed with cholangitis or are suspected to have another active infection requiring antibiotics (such as an infected fluid collection).
  11. * Patients who have received antibiotics within 7 days.
  12. * Patient who have undergone ERCP within 30 days.
  13. * Patients who undergo multiple ERCP for clinical indication will only be eligible to participate in the study for one procedure.
  14. * Patients who have had prior biliary surgeries.
  15. * Patients in whom bile duct decompression is unsuccessful will be excluded as these patients are at increased risk of cholangitis.
  16. * Patients with immediate procedural complications such as a bowel perforation.
  17. * 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.
  18. * Pregnant women
  19. * Patient with allergies to fluoroquinolones. Patient with allergies to cephalosporins or penicillin's may receive fluoroquinolones if they are randomized to antibiotics arm.
  20. * Patients with renal insufficiency (creatinine clearance \<80ml50ml/minute), in whom dose modifications are necessary.
  21. * Patients who withdraw consent will be withdrawn from the study.

Contacts and Locations

Study Contact

James Buxbaum
CONTACT
323 409 5371
jbuxbaum@usc.edu

Principal Investigator

James Buxbaum
PRINCIPAL_INVESTIGATOR
University of Southern California Health Science Center

Study Locations (Sites)

Los Angeles County Hospital
Los Angeles, California, 90033
United States

Collaborators and Investigators

Sponsor: University of Southern California

  • James Buxbaum, PRINCIPAL_INVESTIGATOR, University of Southern California Health Science Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-03-29
Study Completion Date2024-02-23

Study Record Updates

Study Start Date2017-03-29
Study Completion Date2024-02-23

Terms related to this study

Keywords Provided by Researchers

  • levofloxacin
  • Ceftriaxone
  • Cholangitis
  • ERCP

Additional Relevant MeSH Terms

  • Cholangitis