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Search / Trial NCT07043855

Duration of Perioperative Antibiotics in Pancreatoduodenectomy

Launched by ASAN MEDICAL CENTER · Jun 21, 2025

Trial Information

Current as of July 09, 2025

Not yet recruiting

Keywords

Preoperative Antibiotics Perioperative Antibiotics Prophylactic Antibiotics

ClinConnect Summary

This clinical trial is studying how different antibiotic treatments can help prevent infections after a surgery called pancreatoduodenectomy, which is a procedure to remove part of the pancreas and nearby organs. The researchers want to find out if giving patients just one dose of an antibiotic called cefazolin before surgery is as effective as giving a combination of two antibiotics, cefotaxime and metronidazole, for three days after surgery. The goal is to see which approach better reduces the chance of infections where the surgery was done.

Adults aged 18 to 80 who are scheduled for this type of pancreatic surgery may be eligible to join, as long as they don’t have allergies to these antibiotics, active infections before surgery, recent antibiotic use, certain kidney problems, or other specific health concerns like pregnancy. Participants will be randomly assigned to receive either a single antibiotic dose before surgery or a three-day course of antibiotics after surgery. Doctors will then monitor their recovery for about a month to check for any infections or related problems. This study aims to help improve care and recovery for people undergoing this complex surgery.

Gender

ALL

Eligibility criteria

  • 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.

About Asan Medical Center

Asan Medical Center, located in Seoul, South Korea, is a leading healthcare institution renowned for its commitment to advanced medical research and patient care. With a focus on innovative clinical trials, the center aims to enhance healthcare outcomes through rigorous scientific investigation and collaboration. Asan Medical Center is equipped with state-of-the-art facilities and a multidisciplinary team of experts dedicated to exploring new therapeutic approaches across various medical fields. Its robust infrastructure supports a wide range of clinical studies, contributing significantly to the global medical community's understanding of diseases and treatment efficacy.

Locations

Seoul, , Korea, Republic Of

Patients applied

0 patients applied

Trial Officials

Sung-Han Kim, MD, PhD

Principal Investigator

Asan Medical Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported