Clinical Trial

Duration of Perioperative Antibiotics in Pancreatoduodenectomy

Enrolling by Invitation
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Summary
The goal of this clinical trial is to compare two perioperative antibiotic prophylaxis regimens in adult patients undergoing pancreatoduodenectomy (PD) or pylorus-preserving pancreatoduodenectomy (PPPD). The main question it aims to answer is: Is a single preoperative dose of cefazolin non-inferior to the conventional extended regimen (preoperative cefoxitin followed by 3 days of postoperative cefotaxime plus metronidazole) in preventing surgical site infection? Researchers will compare the single-dose cefazolin regimen with the conventional extended regimen to determine whether the shorter regimen results in a comparable rate of postoperative surgical site infection. Participants will be randomized 1:1 to one of the two regimens and followed for 30 days after surgery for surgical site infection and other infectious complications.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-06-21; most recent amendment 2026-05-24.
Status change: Not Yet Recruiting → Enrolling by Invitation 2026-05-24
Trial Details
NCT Number NCT07043855
Lead Sponsor Asan Medical Center
Conditions Pancreatoduodenectomy, PPPD, Infectious Complications
Enrollment 558 participants
Start Date 2026-05-11
Primary Completion 2028-10 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2026-05-28