Duration of Perioperative Antibiotics in Pancreatoduodenectomy
Enrolling by invitation · Not applicable
Conditions studied: Pancreatoduodenectomy, PPPD, Infectious Complications
In brief
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.
Key facts
- Study ID
- NCT07043855
- Run by
- Asan Medical Center
- People needed
- 558
- Starts
- 2026-05-11
- Expected to finish
- 2028-12-01
- Last updated by the study team
- 2026-05-28
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male and female adults aged 18 to 80 years old scheduled for pancreaticoduodenectomy for any indication (including open, laparoscopic, and robotic surgery).
- Patients who have received sufficient explanation about this clinical trial and have voluntarily decided to participate and provided written informed consent.
You may not qualify if…
- History of Type 1 immediate hypersensitivity reaction to cefazolin, cefotaxime, or metronidazole.
- Active or uncontrolled infection prior to surgery for which treatment has not been completed.
- Use of antibiotics for any reason within 1 week prior to surgery.
- Long-term use of immunosuppressants due to other concomitant diseases.
- Undergoing dialysis or having renal dysfunction of KDIGO Grade 3 or higher (GFR < 45).
- Pregnancy or breastfeeding.
Where it is running
- Asan Medical Center — Seoul, South Korea
Full record on ClinicalTrials.gov
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