Antibiotics to Decrease Post ERCP Cholangitis

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.

Conditions

Cholangitis

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Study Overview

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Study Details

Study overview

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.

Randomized Trial of Short Antibiotic Course to Decrease Post ERCP Cholangitis

Antibiotics to Decrease Post ERCP Cholangitis

Condition
Cholangitis
Intervention / Treatment

-

Contacts and Locations

Los Angeles

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

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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 fluoroquinolones. Patient with allergies to cephalosporins or penicillin's may receive fluoroquinolones if they are randomized to antibiotics arm.
  • * Patients with renal insufficiency (creatinine clearance \<80ml50ml/minute), in whom dose modifications are necessary.
  • * Patients who withdraw consent will be withdrawn from the study.

Ages Eligible for Study

18 Years to 90 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Southern California,

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

Study Record Dates

2024-02-23