Antibiotics to Decrease Post ERCP Cholangitis

• Status: Unknown status
• Trial end date: 2021-02-23
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Southern California
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Ceftriaxone; Levofloxacin; Ofloxacin

Criteria

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.