Duration of Perioperative Antibiotics in Pancreatoduodenectomy
NCT ID: NCT07043855
Last Updated: 2025-07-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
558 participants
INTERVENTIONAL
2025-08-31
2027-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Surgical Site Infections After Liver Transplantation Based on Perioperative Antibiotics
NCT02717273
PRevention Of Trauma-related Infections Through an Embedded Clinical Trials Network
NCT06920147
A Single Dose of a Marketed Drug Being Studied for a New Indication to Treat Surgical Site Infection Following Colorectal Surgery as Compared to a Marketed Drug Approved for This Indication (0826-039)
NCT00090272
Postoperative Anti-infective Strategy Following Pancreaticoduodenectomy in Patients With Preoperative Biliary Stent
NCT06123169
Comparison of 9 Doses vs 3 Doses of Post Operative Antibiotics in Live Liver Donors
NCT03765645
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
single dose preoperative antibiotic
Single Preoperative Dose of Cefazolin
single dose preoperative antibiotic
Arm A is a single preoperative dose of cefazolin administered immediately before surgery
prolonged perioperative antibiotics
Preoperative Single-Dose Cefoxitin followed by Three-Day Cefotaxime and Metronidazole Prophylaxis
Prolonged perioperative antibiotics
Preoperative Single-Dose Cefoxitin followed by Three-Day Cefotaxime and Metronidazole Prophylaxis
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
single dose preoperative antibiotic
Arm A is a single preoperative dose of cefazolin administered immediately before surgery
Prolonged perioperative antibiotics
Preoperative Single-Dose Cefoxitin followed by Three-Day Cefotaxime and Metronidazole Prophylaxis
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients who have received sufficient explanation about this clinical trial and have voluntarily decided to participate and provided written informed consent.
Exclusion Criteria
* 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.
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Asan Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Sung-Han Kim
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sung-Han Kim, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Asan Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Asan Medical Center
Seoul, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2025-0529
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.