Duration of Perioperative Antibiotics in Pancreatoduodenectomy

Asan Medical Center

Status: Not yet enrolling

Conditions: PPPD; Infectious Complications; Pancreatoduodenectomy

Treatments: Drug: single dose preoperative antibiotic; Drug: Prolonged perioperative antibiotics

Study type: Interventional

Funder types: Other

Identifiers

NCT07043855

2025-0529

Details and patient eligibility

About

The goal of this clinical trial is to learn if different prophylactic antibiotic regimens can prevent surgical site infections in adult patients undergoing pancreatoduodenectomy. The main questions it aims to answer are:

Does a single preoperative dose of cefazolin reduce the risk of surgical site infection? Does a three-day combination of cefotaxime plus metronidazole reduce the risk of surgical site infection? Researchers will compare a single dose of cefazolin to a three-day course of cefotaxime + metronidazole to see if there is a difference in postoperative infection rates.

Participants will:

• Be randomly assigned to one of two antibiotic regimens before and after surgery
• Receive either Arm A: one dose of cefazolin immediately before surgery Arm B: cefoxitin for perioperative antibiotics followed by cefotaxime plus metronidazole administered for three days after surgery
• Undergo routine postoperative monitoring for signs of infection
• Have any surgical site infections and related complications recorded until 30 days after surgery

Full description

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

Enrollment: 558 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

558 participants in 2 patient groups

single dose preoperative antibiotic

Experimental group

Description:

Single Preoperative Dose of Cefazolin

Treatment:

Drug: single dose preoperative antibiotic

prolonged perioperative antibiotics

Active Comparator group

Description:

Preoperative Single-Dose Cefoxitin followed by Three-Day Cefotaxime and Metronidazole Prophylaxis

Treatment:

Drug: Prolonged perioperative antibiotics