Does Cefoxitin or Piperacillin-Tazobactam Prevent Postoperative Surgical Site Infections After Pancreatoduodenectomy?

Completed · Phase 3

Conditions studied: Pancreatic Cancer, Pancreas Cancer, Pancreatic Diseases

In brief

The purpose of this study is to figure out which commonly used antibiotic, cefoxitin or piperacillin-tazobactam, is better at decreasing the rate of surgical site infections after pancreatoduodenectomy.

Key facts

Study ID: NCT03269994
Run by: Memorial Sloan Kettering Cancer Center
People needed: 967
Starts: 2017-11-21
Expected to finish: 2025-01-28
Last updated by the study team: 2025-10-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Age >/= 18 years
Patients undergoing elective pancreatoduodenectomy (PD) for any diagnosis/indication

You may not qualify if…

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

Where it is running

UC Davis Comprehensive Cancer Center — Sacramento, California, United States
Emory University School of Medicine — Atlanta, Georgia, United States
Northwestern Medicine (Data Collection) — Chicago, Illinois, United States
NorthShore University Health System — Evanston, Illinois, United States
Indiana University — Indianapolis, Indiana, United States
University of Iowa — Iowa City, Iowa, United States
Massachusetts General Hospital — Boston, Massachusetts, United States
University of Washington School of Medicine — St Louis, Missouri, United States
University of Nebraska Medical Center — Omaha, Nebraska, United States
Memorial Sloan Kettering Basking Ridge (Consent only) — Basking Ridge, New Jersey, United States
Hackensack Meridian Health / Hackensack University Medical Center Cancer Center — Hackensack, New Jersey, United States
Memorial Sloan Kettering Commack (Consent only) — Commack, New York, United States
Memoral Sloan Kettering Westchester (Consent only) — Harrison, New York, United States
Mount Sinai Hospital — New York, New York, United States
Mount Sinai West — New York, New York, United States
Memorial Sloan Kettering Cancer Center — New York, New York, United States
Montefiore Health Systems (Montefiore Medical Center) — The Bronx, New York, United States
Duke University — Durham, North Carolina, United States
Brody School of Medicine at East Carolina University — Greenville, North Carolina, United States
Ohio State University — Columbus, Ohio, United States
Providence Health & Services (Portland Med Ctr) — Portland, Oregon, United States
Pennsylvania State Hershey — Hershey, Pennsylvania, United States
Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States
Baptist Memorial Healthcare — Memphis, Tennessee, United States
Baylor Scott & White Health — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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