[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100427537":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":38,"locations":10,"responsibleParty":46,"collaborators":10,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":51,"sex":57,"minAge":58,"maxAge":10,"enrollmentInfo":59,"targetDuration":10,"studyType":62,"phases":10,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":70,"whyStopped":10,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":10},{"fullName":5,"class":6},"University of Pecs","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Preoperative biliary drainage and pancreatoduodenectomy",null,"Patients receiving preoperative biliary drainage before the removal of the tumor.",[13],"Procedure: Preoperative drainage and pancreatoduodenectomy",{"label":15,"type":10,"description":16,"interventionNames":17},"Pancreatoduodenectomy only","Patients undergoing only surgical intervention, without preoperative drainage.",[18],"Procedure: Pancreatoduodenectomy",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":10},"PROCEDURE","Preoperative drainage and pancreatoduodenectomy","Preoperative biliary drainage before surgical removal of the tumor",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":10},"Pancreatoduodenectomy","Pancreatic tumor resection without previous preoperative biliary drainage",[15],[30,34],{"name":31,"affiliation":32,"role":33},"Péter Hegyi","Insitute for Translational Medicine, University of Pécs, Medical School, Pécs, Hungary","STUDY_CHAIR",{"name":35,"affiliation":36,"role":37},"Ákos Szűcs","First Surgical Department of the University of Semmelweis","PRINCIPAL_INVESTIGATOR",[39,43],{"name":35,"role":40,"phone":41,"phoneExt":10,"email":42},"CONTACT","06305359443","szucs.akos@gmail.com",{"name":31,"role":40,"phone":44,"phoneExt":10,"email":45},"06703751031","hegyi2009@gmail.com",{"type":37,"investigatorFullName":47,"investigatorTitle":48,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Szűcs","Principal Investigator, Associate Professor of the First Surgical Department of the University of Semmelweis","100427537","preoperative-biliary-drainage-in-malignant-biliary-obstruction-100427537",false,"NCT04847297","Preoperative Biliary Drainage in Malignant Biliary Obstruction","Preoperative Biliary Drainage in Malignant Biliary Obstruction - an Observational Cohort Study","PEAR","Inclusion Criteria:\n\n1. Patients ≥ 18 years\n2. OJ of malignant origin (pancreatic head or periampullary tumor)\n3. Total bilirubin level ≥ 40 μmol per liter\n4. Signed written informed consent\n\nExclusion Criteria:\n\n1. Proved metastasis\n2. Irresectable tumor\n3. Neo-adjuvant chemotherapy\n4. Co-existing malignancy\n5. Pregnancy\n6. Patients not fit for resection","ALL","18 Years",{"count":60,"type":61},353,"ESTIMATED","OBSERVATIONAL","The first alarming symptom of a malignancy of the pancreas or periampullary tumor can be obstructive jaundice (OJ). Pancreato-duodenectomy (PD) combined with oncological treatment can provide long disease-free survival in resectable cases. The literature regarding the preoperative biliary drainage is controversial. The aim of this multicenter, prospective observational cohort study is to investigate the role of preoperative drainage, and to compare it with surgery alone.",[65],"Pancreatic Cancer",[67,68,69],"pancreatic cancer","biliary drainage","pancreato-duodenectomy","NOT_YET_RECRUITING","2021-04-14",{"date":73,"type":74},"2021-04-19","ACTUAL",{"date":76,"type":61},"2021-09-01",{"date":78,"type":61},"2026-12-31",{"name":5,"class":6}]