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:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-25 @ 1:46 AM
NCT ID:
NCT03269994
Eligibility Criteria:
Inclusion Criteria:
* Age \>/= 18 years
* Patients undergoing elective pancreatoduodenectomy (PD) for any diagnosis/indication
Exclusion Criteria:
* Patients undergoing a minimally invasive PD, such as laparoscopic or robotic PD
* Patients with known and documented allergies to any of the penicillins, cephalosporins, or β-lactamase inhibitors
* Patients who are otherwise ineligible to receive the antibiotics in this study
* Patients highly unlikely to undergo PD according to the surgeon's judgment, such as conditions amenable to pancreas enucleation, ampullectomy, etc.
* Patients with long-term glucocorticosteroid use. The following uses of corticosteroids are permitted: single doses, topical applications (e.g., for rash), inhaled sprays (e.g., for obstructive airways diseases), eye drops or local injections (e.g., intra-articular)
* Patients unable to provide informed consent
* Creatinine clearance (CrCl) \</= 40 mL/min
* Patients receiving hemodialysis or peritoneal dialysis
* Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test
* Patients with a known bacterial infection present at the time of surgery or who received antimicrobial therapy within 7 days prior to surgery
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03269994
Study Brief:
Protocol Section:
NCT03269994