Duration of Perioperative Antibiotics in Pancreatoduodenectomy

1. Brief background: Pancreaticoduodenectomy (PD) is one of the major hepatobiliopancreatic surgical procedures, with postoperative infectious complication rates reaching approximately 20-40%. International guidelines recommend a single preoperative dose of cefazolin as prophylactic antibiotic therapy for PD. However, due to concerns about high infectious complication rates, some institutions administer antibiotics for more than 24 hours postoperatively. This study aims to compare the surgical site infection rates between the internationally recommended single-dose cefazolin regimen and the current practice at Asan Medical Center of perioperative antibiotic prophylaxis consisting of preoperative second-generation cephalosporin (cefoxitin) administration followed by postoperative combined cefotaxime and metronidazole therapy for 3 days in patients undergoing PD. Through this comparison, we seek to contribute to establishing effective and safe antibiotic prophylaxis guidelines and advancing antimicrobial stewardship efforts for this patient population. // 2. Protocol summary: This phase III, single-center randomized study at Seoul, Asan Medical Center will compare the efficacy of two antibiotic prophylaxis regimens in adult patients undergoing pancreatoduodenectomy. A total of 558 participants will be enrolled over a two-year period (from IRB approval), with follow-up through 30 days postoperatively. After informed consent and stratification by biliary stent status, patients will be randomized 1:1 to: (1) Intervention arm: single dose of cefazolin administered within 1 hour before skin incision. (2) Control (conventional) arm: Single dose of cefoxitin within 1 hour before skin incision, followed by cefotaxime plus metronidazole on postoperative days 1-3. Participants will be assessed for surgical site infection (SSI) and other infectious complications. The primary outcome is the incidence of SSI within 30 days