A NSQIP-based randomized clinical trial evaluating choice of prophylactic antibiotics for pancreaticoduodenectomy

J Surg Oncol. 2021 May;123(6):1387-1394. doi: 10.1002/jso.26402.


Surgical site infection after pancreaticoduodenectomy is often caused by pathogens resistant to standard prophylactic antibiotics, suggesting that broad-spectrum antibiotics may be more effective prophylactic agents. This article describes the rationale and methodology underlying a multicenter randomized trial evaluating piperacillin-tazobactam compared with cefoxitin for surgical site infection prevention following pancreaticoduodenectomy. As the first US randomized surgical trial to utilize a clinical registry for data collection, this study serves as proof of concept for registry-based clinical trials.

Keywords: antibiotic prophylaxis; cefoxitin; clinical trial; pancreaticoduodenectomy; piperacillin; surgical wound infection; tazobactam drug combination.

Publication types

  • Review

MeSH terms

  • Antibiotic Prophylaxis / methods*
  • Cefoxitin / administration & dosage
  • Clinical Trials, Phase III as Topic
  • Humans
  • Pancreatic Neoplasms / surgery*
  • Pancreaticoduodenectomy / adverse effects
  • Pancreaticoduodenectomy / methods*
  • Piperacillin, Tazobactam Drug Combination / administration & dosage
  • Randomized Controlled Trials as Topic
  • Registries
  • Surgical Wound Infection / etiology
  • Surgical Wound Infection / prevention & control


  • Piperacillin, Tazobactam Drug Combination
  • Cefoxitin