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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
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

Full criteria on ClinicalTrials.gov

Sites (32)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hamilton Health Sciences Center (Juravinski Hospital)
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HamiltonCanadaUnknown status
Ottawa Hospital
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OttawaCanadaUnknown status
Sunnybrook Health Sciences Centre
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TorontoCanadaUnknown status
Emory University School of Medicine
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AtlantaUnited StatesUnknown status
Memorial Sloan Kettering Basking Ridge (Consent Only)
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Basking RidgeUnited StatesUnknown status
Massachusetts General Hospital
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BostonUnited StatesUnknown status
Northwestern Medicine (Data Collection)
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ChicagoUnited StatesUnknown status
Ohio State University
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ColumbusUnited StatesUnknown status
Memorial Sloan Kettering Commack (Consent only)
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CommackUnited StatesUnknown status
Baylor Scott & White Health
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DallasUnited StatesUnknown status
Duke University
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DurhamUnited StatesUnknown status
Northshore University Health System
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EvanstonUnited StatesUnknown status
Brody School of Medicine at East Carolina University
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GreenvilleUnited StatesUnknown status
Hackensack Meridian Health / Hackensack University Medical Center Cancer Center
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HackensackUnited StatesUnknown status
Memoral Sloan Kettering Westchester (Consent only)
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HarrisonUnited StatesUnknown status
Pennsylvania State Hershey
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HersheyUnited StatesUnknown status
Indiana University
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IndianapolisUnited StatesUnknown status
University of Iowa
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Iowa CityUnited StatesUnknown status
Gundersen Lutheran Medical Foundation
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La CrosseUnited StatesUnknown status
University of Wisconsin
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MadisonUnited StatesUnknown status
Baptist Memorial Healthcare
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MemphisUnited StatesUnknown status
Intermountain Healthcare
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MurrayUnited StatesUnknown status
Mount Sinai Hospital
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New YorkUnited StatesUnknown status
Mount Sinai West
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New YorkUnited StatesUnknown status
Memorial Sloan-Kettering Cancer Center
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New YorkUnited StatesUnknown status
University of Nebraska Medical Center
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OmahaUnited StatesUnknown status
Thomas Jefferson University Hospital
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PhiladelphiaUnited StatesUnknown status
Providence Health & Services (Portland Med Ctr)
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PortlandUnited StatesUnknown status
UC Davis Comprehensive Cancer Center
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SacramentoUnited StatesUnknown status
University of Utah
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Salt Lake CityUnited StatesUnknown status
University of Washington School of Medicine
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St LouisUnited StatesUnknown status
Montefiore Health Systems (Montefiore Medical Center)
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The BronxUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.