AzTrials
AzTrials

PancreatoduodenectomyNCT07043855

Duration of Perioperative Antibiotics in Pancreatoduodenectomy

A study testing single dose preoperative antibiotic and Prolonged perioperative antibiotics in people with Pancreatoduodenectomy and PPPD, run by Asan Medical Center at 1 site in South Korea.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
single dose preoperative antibiotic and Prolonged perioperative antibiotics
Could I receive a placebo?
No, everyone receives an active treatment
How many people
558 participants
Where
1 siteSouth Korea
Study dates
11 May 2026to Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

South Korea1 site

  • Asan Medical Center

    Seoul, 05505

Other trials in South Korea

About this study

Official title: Duration of Perioperative Antibiotic Prophylaxis in Patients Undergoing Pancreatoduodenectomy: a Randomized Controlled Trial

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.

Read the detailed description
  1. Brief background Pancreatoduodenectomy (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 antibiotic prophylaxis for PD. However, due to concerns about high infectious complication rates, some institutions administer antibiotics for more than 24 hours postoperatively. This study compares surgical site infection rates between the internationally recommended single-dose cefazolin regimen and the current practice at Asan Medical Center, which consists of a preoperative second-generation cephalosporin (cefoxitin) followed by postoperative cefotaxime plus metronidazole for 3 days. Through this comparison, the study seeks to contribute to establishing effective and safe antibiotic prophylaxis guidelines and to advancing antimicrobial stewardship efforts for this patient population.
  2. Protocol summary This phase III, single-center, randomized, non-inferiority trial conducted at Asan Medical Center, Seoul, compares two antibiotic prophylaxis regimens in adult patients undergoing PD or PPPD. 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 preoperative biliary stent status, participants will be randomized 1:1 to: Single-dose arm: a single dose of cefazolin administered within 1 hour before skin incision. Conventional (extended) arm: a single dose of cefoxitin within 1 hour before skin incision, followed by cefotaxime plus metronidazole on postoperative days 0-3. The primary outcome is the incidence of surgical site infection within 30 days after surgery.
  3. Statistical considerations The trial is designed to assess the non-inferiority of the single-dose cefazolin regimen relative to the conventional extended regimen. Assuming a 30-day surgical site infection rate of 20% in the control group, a non-inferiority margin of 10%, a one-sided alpha of 0.025, and 80% power, 252 participants per group (504 total) are required. Accounting for an anticipated 10% dropout rate, a total of 558 participants will be enrolled. The non-inferiority test for the difference between two independent proportions was used for sample size calculation (PASS software, version 15).
  4. Analysis population The primary analysis will be performed on a modified intention-to-treat (mITT) basis, including all randomized participants who underwent pancreatic resection, regardless of the final resection type (e.g., conversion from planned pancreatoduodenectomy to total pancreatectomy). Participants who underwent surgical exploration without resection (open-and-close) are excluded, as they are not at risk for the primary endpoint. Participants are analyzed according to their randomized treatment assignment regardless of dosing protocol adherence. Sensitivity analyses, including a conservative intention-to-treat analysis and a per-protocol analysis, will also be performed.
Being tested
single dose preoperative antibiotic, Prolonged perioperative antibiotics
Keywords
preoperative antibiotics, perioperative antibiotics, prophylactic antibiotics

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • single dose preoperative antibioticDrug

    Also called cefazolin

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

  • Prolonged perioperative antibioticsDrug

    Also called cefoxitin followed by 3-day cefotaxime plus metronidazole

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

Study groups in NCT07043855
Study groupRoleWhat they receive
single dose preoperative antibioticExperimentalSingle Preoperative Dose of Cefazolin
Receives: Drug: single dose preoperative antibiotic
prolonged perioperative antibioticsActive comparatorPreoperative Single-Dose Cefoxitin followed by Three-Day Cefotaxime and Metronidazole Prophylaxis
Receives: Drug: Prolonged perioperative antibiotics

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Surgical site infection

    superficial/deep/organ-space infection

    Measured: within 30 days after PD/PPPD

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2025
  2. Study start11 May 2026
  3. Primary completionOct 2028 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
558 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07043855
Sponsor's protocol ID
2025-0529
Status last verified
Jun 2025
First submitted
21 Jun 2025
Last updated
28 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: IPD might not be shared

Publications

  • 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.

    PubMed 31152686

  • 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.

    PubMed 23461695

  • 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.

    PubMed 37389897

  • 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.

    PubMed 37078771

  • 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.

    PubMed 27759623

  • 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.

    PubMed 30460348

  • 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.

    PubMed 28371248

Questions about this trial

What is this clinical trial studying?

A study testing single dose preoperative antibiotic and Prolonged perioperative antibiotics in people with Pancreatoduodenectomy and PPPD, run by Asan Medical Center at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Surgical site infection (time frame: within 30 days after PD/PPPD). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07043855, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in