Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-24 @ 11:30 PM
NCT ID:
NCT03087656
Eligibility 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 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.
Withdrawal Criteria:
* Patients who withdraw consent will be withdrawn from the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT03087656
Study Brief:
Protocol Section:
NCT03087656