Duration of Perioperative Antibiotics in Pancreatoduodenectomy

NCT07043855 | Not Yet Recruiting

• 1 other identifier: 2025-0529
• Study Type: interventional
• Target: 558
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pancreatoduodenectomy; PPPD; Infectious Complications

Keywords

preoperative antibiotics; perioperative antibiotics; prophylactic antibiotics

Outcome Measures

Primary Outcomes (1)

• Surgical site infection

  superficial/deep wound infection, organ-space infection

  within 30 days after PD/PPPD

Study Arms (2)

single dose preoperative antibiotic

EXPERIMENTAL

Single Preoperative Dose of Cefazolin

Drug: single dose preoperative antibiotic

prolonged perioperative antibiotics

ACTIVE COMPARATOR

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

Drug: Prolonged perioperative antibiotics

Interventions

single dose preoperative antibiotic DRUG

Arm A is a single preoperative dose of cefazolin administered immediately before surgery

Also known as: cefazolin

single dose preoperative antibiotic

Prolonged perioperative antibiotics DRUG

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

Also known as: cefoxitin followed by 3-day cefotaxime plus metronidazole

prolonged perioperative antibiotics

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, 05505, South Korea

Location

Related Publications (7)

• Hwang DW, Kim HJ, Lee JH, Song KB, Kim MH, Lee SK, Choi KT, Jun IG, Bang JY, Kim SC. Effect of Enhanced Recovery After Surgery program on pancreaticoduodenectomy: a randomized controlled trial. J Hepatobiliary Pancreat Sci. 2019 Aug;26(8):360-369. doi: 10.1002/jhbp.641. Epub 2019 Jul 2.

  PMID: 31152686 BACKGROUND

• Bratzler DW, Dellinger EP, Olsen KM, Perl TM, Auwaerter PG, Bolon MK, Fish DN, Napolitano LM, Sawyer RG, Slain D, Steinberg JP, Weinstein RA; American Society of Health-System Pharmacists (ASHP); Infectious Diseases Society of America (IDSA); Surgical Infection Society (SIS); Society for Healthcare Epidemiology of America (SHEA). Clinical practice guidelines for antimicrobial prophylaxis in surgery. Surg Infect (Larchmt). 2013 Feb;14(1):73-156. doi: 10.1089/sur.2013.9999. Epub 2013 Mar 5. No abstract available.

  PMID: 23461695 BACKGROUND

• Boyev A, Arvide EM, Newhook TE, Prakash LR, Bruno ML, Dewhurst WL, Kim MP, Maxwell JE, Ikoma N, Snyder RA, Lee JE, Katz MHG, Tzeng CD. Prophylactic Antibiotic Duration and Infectious Complications in Pancreatoduodenectomy Patients With Biliary Stents: Opportunity for De-escalation. Ann Surg. 2024 Apr 1;279(4):657-664. doi: 10.1097/SLA.0000000000005982. Epub 2023 Jul 3.

  PMID: 37389897 BACKGROUND

• D'Angelica MI, Ellis RJ, Liu JB, Brajcich BC, Gonen M, Thompson VM, Cohen ME, Seo SK, Zabor EC, Babicky ML, Bentrem DJ, Behrman SW, Bertens KA, Celinski SA, Chan CHF, Dillhoff M, Dixon MEB, Fernandez-Del Castillo C, Gholami S, House MG, Karanicolas PJ, Lavu H, Maithel SK, McAuliffe JC, Ott MJ, Reames BN, Sanford DE, Sarpel U, Scaife CL, Serrano PE, Smith T, Snyder RA, Talamonti MS, Weber SM, Yopp AC, Pitt HA, Ko CY. Piperacillin-Tazobactam Compared With Cefoxitin as Antimicrobial Prophylaxis for Pancreatoduodenectomy: A Randomized Clinical Trial. JAMA. 2023 May 9;329(18):1579-1588. doi: 10.1001/jama.2023.5728.

  PMID: 37078771 BACKGROUND

• Sugawara G, Yokoyama Y, Ebata T, Mizuno T, Yagi T, Ando M, Nagino M. Duration of Antimicrobial Prophylaxis in Patients Undergoing Major Hepatectomy With Extrahepatic Bile Duct Resection: A Randomized Controlled Trial. Ann Surg. 2018 Jan;267(1):142-148. doi: 10.1097/SLA.0000000000002049.

  PMID: 27759623 BACKGROUND

• Yamamoto T, Satoi S, Fujii T, Yamada S, Yanagimoto H, Yamaki S, Takami H, Hirooka S, Kosaka H, Kotsuka M, Miyara T, Kodera Y. Dual-center randomized clinical trial exploring the optimal duration of antimicrobial prophylaxis in patients undergoing pancreaticoduodenectomy following biliary drainage. Ann Gastroenterol Surg. 2018 Sep 17;2(6):442-450. doi: 10.1002/ags3.12209. eCollection 2018 Nov.

  PMID: 30460348 BACKGROUND

• Okamura K, Tanaka K, Miura T, Nakanishi Y, Noji T, Nakamura T, Tsuchikawa T, Okamura K, Shichinohe T, Hirano S. Randomized controlled trial of perioperative antimicrobial therapy based on the results of preoperative bile cultures in patients undergoing biliary reconstruction. J Hepatobiliary Pancreat Sci. 2017 Jul;24(7):382-393. doi: 10.1002/jhbp.453. Epub 2017 May 6.

  PMID: 28371248 BACKGROUND

MeSH Terms

Interventions

Cefazolin; Cefotaxime; Metronidazole

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Cephacetrile; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Officials

• Sung-Han Kim, MD, PhD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sung-Han Kim, MD, PhD

CONTACT

+82-2-3010-3305; shkimmd@amc.seoul.kr

So Yun Lim, MD, PhD

CONTACT

+82-2-3010-3261; soyun_lim@amc.seoul.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 21, 2025
• First Posted: June 29, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: July 2, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)