[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"antibiotherapy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:antibiotherapy":39},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":12,"acronym":13,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":5},"100525548",false,"NCT06123169","Postoperative Anti-infective Strategy Following Pancreaticoduodenectomy in Patients With Preoperative Biliary Stent","FRENCH24 ANIS","Inclusion Criteria:\n\n* Planned pancreaticoduodenectomy for periampullary neoplasms\n* Endoscopic or radiological pre-operative biliary drainage\n* Age ≥ 18 years old\n* Patient able to comply with the study protocol, in the investigator's judgment\n* Patient affiliated with, or beneficiary of a social security (national health insurance) category\n* Person of full age having read and understood the information letter and signed the consent form\n* 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.\n* Women permanently sterile (hysterectomy, bilateral salpingectomy and bilateral oophorectomy.\n* 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.\n\nExclusion Criteria:\n\n* Contraindication to PIPERACILLIN\u002FTAZOBACTAM PANPHARMA 4g \u002F 500mg powder for solution for injection in accordance with its SmPC\n* Patients allergic to beta-lactam antibiotics\n* Others pancreatic resection\n* Absence of preoperative biliary drainage\n* Surgical or anaesthesiological contra-indications:\n* 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\n* major non-controlled infection\n* severe liver failure\n* Medical, geographical, sociological, psychological or legal conditions that would not permit the patient to complete the study or sign informed consent\n* Any significant disease, which, in the investigator's opinion, would exclude the patient from the study\n* Pregnant or parturient or breastfeeding woman or absence of contraceptionn\n* Person deprived of liberty by administrative or judicial decision or person placed under judicial protection, under guardianship or supervision\n* Simultaneous participation in another interventional research with the same primary endpoint.","ALL","18 Years",{"count":18,"type":19},326,"ESTIMATED","INTERVENTIONAL",[22],"PHASE3","The main objective of the study is to compare 2 broad-spectrum antibiotic (Piperacillin \u002F 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)",[25,26],"Pancreaticoduodenectomy","Antibiotherapy","NOT_YET_RECRUITING","2026-06-05",{"date":30,"type":31},"2026-06-09","ACTUAL",{"date":33,"type":19},"2026-07",{"date":35,"type":19},"2028-09",{"name":37,"class":38},"University Hospital, Rouen","OTHER",""]