[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100537848":3},{"organization":4,"armGroups":7,"interventions":7,"overallOfficials":7,"centralContacts":8,"locations":18,"responsibleParty":38,"collaborators":7,"id":40,"slug":41,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":42,"sex":48,"minAge":49,"maxAge":7,"enrollmentInfo":50,"targetDuration":7,"studyType":53,"phases":7,"briefSummary":54,"conditions":55,"keywords":59,"overallStatus":21,"whyStopped":7,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},{"fullName":5,"class":6},"Centre Hospitalier Universitaire de Besancon","OTHER",null,[9,14],{"name":10,"role":11,"phone":12,"phoneExt":7,"email":13},"Alexandre DOUSSOT, MD, PhD","CONTACT","+33381668343","adoussot@chu-besancon.fr",{"name":15,"role":11,"phone":16,"phoneExt":7,"email":17},"astrid POZET","+33381218988","apozet@chu-besancon.fr",[19],{"facility":20,"status":21,"city":22,"state":7,"zip":23,"country":24,"countryCode":25,"cosmosGeoPoint":26,"geoPoint":31,"contacts":32},"University Hospital of Besançon","RECRUITING","Besançon","25000","France","FR",{"type":27,"coordinates":28},"Point",[29,30],6.01815,47.24878,{"lat":30,"lon":29},[33,35],{"name":34,"role":11,"phone":7,"phoneExt":7,"email":7},"Alexandre Doussot, MD, PhD",{"name":36,"role":37,"phone":7,"phoneExt":7,"email":7},"Prof. Alexandre Doussot","PRINCIPAL_INVESTIGATOR",{"type":39,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100537848","metabolomic-and-immune-profiling-in-the-development-of-pancreatic-fistulas-after-cephalic-duodenopancreatectomy-100537848",false,"NCT06283160","METabolomic and Immune PROfiling in the Development of Pancreatic Fistulas After cepHalic duodEnopancreatectomy","Interest of Metabolomic and Immune Profiling in the Development of Pancreatic Fistulas After Duodenopancreatectomy","PROMETHEE","Inclusion Criteria:\n\n* patients scheduled to undergo elective pancreaticoduodenectomy\n* Non-opposition of the subject to participate in the study.\n* Affiliated to the French social security system (CMU included).\n\nExclusion Criteria:\n\n* Emergent surgery.\n* Pregnant patients.\n* Refusal to participate or inability to provide informed consent.\n* Patient under legal protection (individuals under guardianship by court order).","ALL","18 Years",{"count":51,"type":52},80,"ESTIMATED","OBSERVATIONAL","Pancreatoduodenectomy is the standard surgical operation for benign or malign pancreatic lesions. Pancreatic Fistula (PF) or Postpancreatectomy Acute Pancreatitis (PPAP) are the major complications associated with that type of surgery. We need to develop preventive measures for these complications, which requires a better understanding of their physiopathology.\n\nThe aim of this prospective monocentric and observational study is to identify predictive biomarkers and\u002For risk factors for PF or PPAP using metabolomics. The Profiling of circulating metabolites is indeed an original and promising approach for this purpose. We will also investigate the patient's immune status and its association with the occurrence of post-surgical complications.\n\nParticipants will be adult patients scheduled to undergo elective pancreaticoduodenectomy. Surgery and patient's management will be as usual. During surgery, a fragment (0.1-0.2 g) of non-tumoral pancreatic tissue will be removed and frozen at -80°C for metabolomic analysis. For immunological assessment, 4 blood samples will be collected (before surgery and then 7 days, 1 and 3 months after, blood sampling).",[56,57,58],"Pancreatic Fistula","Acute Pancreatitis","Pancreatoduodenectomy",[60,61,62,63],"Metabolomics","Immune response","Pancreatic fistula","pancreatoduodenectomy","2024-10-10",{"date":66,"type":67},"2024-10-15","ACTUAL",{"date":69,"type":67},"2024-03-01",{"date":71,"type":52},"2026-05-30",{"name":5,"class":6},1]