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Postoperative anti-infective strategy following pancreaticoduodenectomy in patients with preoperative biliary stent FRENCH24 ANIS
EU CTIS ID: 2024-515181-14-00
What this study is testing
To compare 2 broad-spectrum antibiotic (Piperacillin / Tazobactam) treatment modalities to demonstrate the superiority of a 5-day post-operative antibiotic therapy to antibiotic prophylaxis on the occurrence of surgical site infections (SSI)
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- Contraindication to PIPERACILLIN/TAZOBACTAM PANPHARMA 4g / 500mg powder for solution for injection in accordance with its SmPC
- Person deprived of liberty by administrative or judicial decision or person placed under judicial protection, under guardianship or supervision
- Severe renal failure
- Simultaneous participation in another interventional research with the same primary endpoint.
- Patients allergic to beta-lactam antibiotics
- Others pancreatic resection
See the full eligibility 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.
- Contraindication to PIPERACILLIN/TAZOBACTAM PANPHARMA 4g / 500mg powder for solution for injection in accordance with its SmPC
- Person deprived of liberty by administrative or judicial decision or person placed under judicial protection, under guardianship or supervision
- Severe renal failure
- Simultaneous participation in another interventional research with the same primary endpoint.
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.