[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100525548":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":35,"locations":46,"responsibleParty":65,"collaborators":34,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":34,"enrollmentInfo":76,"targetDuration":34,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":34,"overallStatus":86,"whyStopped":34,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"University Hospital, Rouen","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Broad spectrum antibioprophylaxis","ACTIVE_COMPARATOR","Antibioprophylaxis with Piperacillin-tazobactam during DPC.",[13],"Drug: Antibioprophylaxis (Piperacillin-tazobactam)",{"label":15,"type":16,"description":17,"interventionNames":18},"Broad spectrum antibiotherapy","EXPERIMENTAL","5 days Antibiotherapy (Piperacillin-tazobactam) from surgery.",[19],"Drug: 5 days Antibiotherapy (Piperacillin-tazobactam)",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Antibioprophylaxis (Piperacillin-tazobactam)","antibiotic prophylaxis during surgery",[9],[27],"Control arm",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"5 days Antibiotherapy (Piperacillin-tazobactam)","5 days Antibiotherapy from surgery",[15],[33],"experimental arm",null,[36,42],{"name":37,"role":38,"phone":39,"phoneExt":40,"email":41},"Lilian Schwarz","CONTACT","0232888416","+33","lilian.schwarz@chu-rouen.fr",{"name":43,"role":38,"phone":44,"phoneExt":40,"email":45},"Julie Rondeaux, PhD","0232885427","julie.rondeaux@chu-rouen.fr",[47],{"facility":48,"status":34,"city":49,"state":34,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"CHU de ROUEN","Rouen","76031","France","FR",{"type":54,"coordinates":55},"Point",[56,57],1.09932,49.44313,{"lat":57,"lon":56},[60,63],{"name":61,"role":38,"phone":62,"phoneExt":40,"email":41},"Lilian Schwarz, Pr","02 32 88 84 18",{"name":61,"role":64,"phone":34,"phoneExt":34,"email":34},"PRINCIPAL_INVESTIGATOR",{"type":66,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR","100525548","phase-3-postoperative-anti-infective-strategy-following-pancreaticoduodenectomy-in-patients-with-preoperative-biliary-stent-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":77,"type":78},326,"ESTIMATED","INTERVENTIONAL",[81],"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)",[84,85],"Pancreaticoduodenectomy","Antibiotherapy","NOT_YET_RECRUITING","2026-06-05",{"date":89,"type":90},"2026-06-09","ACTUAL",{"date":92,"type":78},"2026-07",{"date":94,"type":78},"2028-09",{"name":5,"class":6},1]