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Duration of Perioperative Antibiotics in Pancreatoduodenectomy

NCT07043855 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 558

Last updated 2026-05-28

No results posted yet for this study

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.

Conditions

  • Pancreatoduodenectomy
  • PPPD
  • Infectious Complications

Interventions

DRUG

single dose preoperative antibiotic

Arm A is a single preoperative dose of cefazolin administered within 1 hour before surgery

DRUG

Prolonged perioperative antibiotics

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

Sponsors & Collaborators

  • Asan Medical Center

    lead OTHER

Principal Investigators

  • Sung-Han Kim, MD, PhD · Asan Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-11
Primary Completion
2028-10-31
Completion
2028-12-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07043855 on ClinicalTrials.gov