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Could 5 days of antibiotics cut infections after pancreatic surgery?

NCT ID NCT06123169

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 326 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

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How to take part

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  1. The places running it

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  2. The official record

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Contacts and locations

Locations

  • CHU de ROUEN

    Rouen, 76031, France

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