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Not Yet Recruiting NCT06123169

Postoperative Anti-infective Strategy Following Pancreaticoduodenectomy in Patients With Preoperative Biliary Stent

Conditions: Pancreaticoduodenectomy, Antibiotherapy

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 326
Sponsor: University Hospital, Rouen

Location: CHU de ROUEN Rouen

Summary

The main objective of the study is to compare 2 broad-spectrum antibiotic (Piperacillin / Tazobactam) treatment modalities, following pancreaticoduodenectomy in patients with preoperative biliary stent, to demonstrate the superiority of a 5-day post-operative antibiotic therapy to antibiotic prophylaxis on the occurrence of surgical site infections (SSI)

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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06123169). StuddyBuddy aggregates publicly available trial information.