Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-24 @ 10:52 PM
NCT ID:
NCT06123169
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06123169
Study Brief:
Protocol Section:
NCT06123169