NCT03269994CompletedPhase 3
Does Cefoxitin or Piperacillin-Tazobactam Prevent Postoperative Surgical Site Infections After Pancreatoduodenectomy?
A Phase III Multicenter, Open Label Randomized Controlled Trial of Cefoxitin Versus Piperacillin-Tazobactam as Surgical Antibiotic Prophylaxis in Patients Undergoing Pancreatoduodenectomy
Source: ClinicalTrials.gov · Last updated 21 Oct 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 967 (actual)
- First submitted
- 30 Aug 2017
- Start date
- 21 Nov 2017
- Primary completion date
- 28 Jan 2025
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Diseases
- Pancreatic cancer
- NCT number
- NCT03269994
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 967
- From 21 Nov 2017 to the primary completion date, 28 Jan 2025
- 32 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients receiving hemodialysis or peritoneal dialysis
- Patients with a known bacterial infection present at the time of surgery or who received antimicrobial therapy within 7 days prior to surgery
Other illness
- Patients with known and documented allergies to any of the penicillins, cephalosporins, or β-lactamase inhibitors
- 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)
Lab values
- Creatinine clearance (CrCl) \</= 40 mL/min
- 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
Other
- Patients undergoing a minimally invasive PD, such as laparoscopic or robotic PD
- Patients who are otherwise ineligible to receive the antibiotics in this study
- Patients unable to provide informed consent
Who the study is looking for
- Age \>/= 18 years
- Patients undergoing elective pancreatoduodenectomy (PD) for any diagnosis/indication
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (32)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hamilton Health Sciences Center (Juravinski Hospital) Coordinator of this site? Confirm its status | Hamilton | Canada | Unknown status |
| Ottawa Hospital Coordinator of this site? Confirm its status | Ottawa | Canada | Unknown status |
| Sunnybrook Health Sciences Centre Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Emory University School of Medicine Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Memorial Sloan Kettering Basking Ridge (Consent Only) Coordinator of this site? Confirm its status | Basking Ridge | United States | Unknown status |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Northwestern Medicine (Data Collection) Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Ohio State University Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| Memorial Sloan Kettering Commack (Consent only) Coordinator of this site? Confirm its status | Commack | United States | Unknown status |
| Baylor Scott & White Health Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Duke University Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| Northshore University Health System Coordinator of this site? Confirm its status | Evanston | United States | Unknown status |
| Brody School of Medicine at East Carolina University Coordinator of this site? Confirm its status | Greenville | United States | Unknown status |
| Hackensack Meridian Health / Hackensack University Medical Center Cancer Center Coordinator of this site? Confirm its status | Hackensack | United States | Unknown status |
| Memoral Sloan Kettering Westchester (Consent only) Coordinator of this site? Confirm its status | Harrison | United States | Unknown status |
| Pennsylvania State Hershey Coordinator of this site? Confirm its status | Hershey | United States | Unknown status |
| Indiana University Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| University of Iowa Coordinator of this site? Confirm its status | Iowa City | United States | Unknown status |
| Gundersen Lutheran Medical Foundation Coordinator of this site? Confirm its status | La Crosse | United States | Unknown status |
| University of Wisconsin Coordinator of this site? Confirm its status | Madison | United States | Unknown status |
| Baptist Memorial Healthcare Coordinator of this site? Confirm its status | Memphis | United States | Unknown status |
| Intermountain Healthcare Coordinator of this site? Confirm its status | Murray | United States | Unknown status |
| Mount Sinai Hospital Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Mount Sinai West Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| University of Nebraska Medical Center Coordinator of this site? Confirm its status | Omaha | United States | Unknown status |
| Thomas Jefferson University Hospital Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Providence Health & Services (Portland Med Ctr) Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| UC Davis Comprehensive Cancer Center Coordinator of this site? Confirm its status | Sacramento | United States | Unknown status |
| University of Utah Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| University of Washington School of Medicine Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Montefiore Health Systems (Montefiore Medical Center) Coordinator of this site? Confirm its status | The Bronx | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.