Clinical Trial: Antibiotics to Decrease Post ERCP Cholangitis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Randomized Trial of Short Antibiotic Course to Decrease Post ERCP Cholangitis

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.


Detailed Summary:

OBJECTIVES AND PURPOSE

The aim is to determine whether a brief course of antibiotics following therapeutic ERCP can reduce post-ERCP cholangitis in patients for whom antibiotics are not already indicated.

STUDY DESIGN

The study will be a prospective, randomized trial consisting of 452 patients who are scheduled to undergo therapeutic ERCP at the LAC+USC Medical Center for standard indications. Patients undergoing ERCP for therapy of bile duct problems including choledocholithiasis, malignant obstruction, jaundice, and bile leak will be eligible. Those with mandatory antibiotic requirement will be excluded.

Patients will be randomly assigned in a 1:1 ratio using a computer generated randomization schedule and allocation will be concealed.

Patients will be randomized during the ERCP procedure, once decompression of the duct is achieved (either obstruction cleared or stent placed), to ensure that patients who are at increased risk (because of inability to decompress the duct with a stent or clearance) will be excluded from the study. Those randomized to the antibiotics arm will receive intravenous antibiotics (ceftriaxone 1gm) immediately following the ERCP procedure and will take oral antibiotics (levofloxacin 500mg) once daily for 3 subsequent days. This regimen is chosen to most closely reflect the actual clinical practice in our center. Those in the no antibiotics arm will not receive antibiotics. However, if they develop findings of cholangitis or other infection they will be treated with antibiotics. Comprehensive data including procedure indication will be recorded.

The primary outcome will be the development of post-ERCP
Sponsor: University of Southern California

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: University of Southern California

Dates:
Date Received: March 5, 2017
Date Started: March 29, 2017
Date Completion: February 23, 2019
Last Updated: April 18, 2017
Last Verified: April 2017