Could 5 days of antibiotics cut infections after pancreatic surgery?
NCT ID NCT06123169
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares two antibiotic strategies in 326 adults undergoing pancreatic surgery who had a bile duct stent placed before surgery. One group gets antibiotics only during surgery, the other gets them for 5 days after. The goal is to see if the longer course reduces surgical site infections, including pancreatic leaks. The trial is not yet recruiting.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Piperacillin-tazobactam (an antibiotic)
- What this could lead to
- If successful, this could establish a standard antibiotic regimen to prevent serious infections after pancreatic surgery in patients with a prior bile duct stent.
- What could go wrong
- This is a Phase 3 trial, but it has not yet started recruiting. The benefit may be small, and antibiotics carry risks like allergic reactions or drug-resistant infections.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 326 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Planned pancreaticoduodenectomy for periampullary neoplasms * Endoscopic or radiological pre-operative biliary drainage * Age ≥ 18 years old * Patient able to comply with the study protocol, in the investigator's judgment * Patient affiliated with, or beneficiary of a social security (national health insurance) category * Person of full age having read and understood the information letter and signed the consent form * Women of childbearing potential (a woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile) with hightly effective contraception (Cf. CTFG) combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation, progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device (IUD), intrauterine hormone-releasing system ( IUS), bilateral tubal occlusion, vasectomised partner, sexual abstinence) since 1 month and during the duration of the study and a negative blood pregnancy test by beta-HCG at inclusion. * Women permanently sterile (hysterectomy, bilateral salpingectomy and bilateral oophorectomy. * Postmenopausal women: A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient. Exclusion Criteria: * Contraindication to PIPERACILLIN/TAZOBACTAM PANPHARMA 4g / 500mg powder for solution for injection in accordance with its SmPC * Patients allergic to beta-lactam antibiotics * Others pancreatic resection * Absence of preoperative biliary drainage * Surgical or anaesthesiological contra-indications: * non-controlled congestive heart failure - non-treated angina - recent myocardial infarction (in the previous year) - non-controlled AHT (SBP \>160 mm or DBP \> 100 mm, despite optimal drug treatment), long QT * major non-controlled infection * severe liver failure * Medical, geographical, sociological, psychological or legal conditions that would not permit the patient to complete the study or sign informed consent * Any significant disease, which, in the investigator's opinion, would exclude the patient from the study * Pregnant or parturient or breastfeeding woman or absence of contraceptionn * Person deprived of liberty by administrative or judicial decision or person placed under judicial protection, under guardianship or supervision * Simultaneous participation in another interventional research with the same primary endpoint.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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CHU de ROUEN
Rouen, 76031, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Radiation before pancreatic surgery may prevent dangerous leaks
- Pain-block study for major pancreas surgery fizzles out
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