[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100617996":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":45,"locations":26,"responsibleParty":54,"collaborators":26,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":59,"sex":65,"minAge":66,"maxAge":26,"enrollmentInfo":67,"targetDuration":26,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":78,"overallStatus":83,"whyStopped":26,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":26},{"fullName":5,"class":6},"Azienda Ospedaliera Universitaria Integrata Verona","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Suprapapillary","EXPERIMENTAL","ERCP for malignant stenosis of bile duct with suprapapillary stents positioning (experimental)",[13],"Procedure: ERCP with suprapapillary stent placement",{"label":15,"type":16,"description":17,"interventionNames":18},"Trans Papillary","ACTIVE_COMPARATOR","ERCP for malignant stenosis of bile duct with transpapillary stents positioning (Standard of care).",[19],"Procedure: ERCP with transpapillary stent placement",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","ERCP with suprapapillary stent placement","ERCP with no sphincterotomy and placement of plastic stents above the papilla of Vater.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"ERCP with transpapillary stent placement","Standard ERCP with or without sphincterotomy with trans papillary stent placement",[15],[32,36,39,43],{"name":33,"affiliation":34,"role":35},"Andrea Ruzzenente, Professor","Integrated University Hospital Verona","PRINCIPAL_INVESTIGATOR",{"name":37,"affiliation":34,"role":38},"Stefano Francesco Crinò, Consultant","STUDY_DIRECTOR",{"name":40,"affiliation":41,"role":42},"Edoardo Poletto, PhD Candidate, Consultant","Integrated university Hospital Verona","STUDY_CHAIR",{"name":44,"affiliation":34,"role":42},"Maria Cristina Conti Bellocchi, Consultant",[46,50],{"name":33,"role":47,"phone":48,"phoneExt":26,"email":49},"CONTACT","+39 0458124644","andrea.ruzzenente@univr.it",{"name":51,"role":47,"phone":52,"phoneExt":26,"email":53},"Edoardo Poletto, PhD Candidate - Consultant","+39 3452308635","edoardo.poletto@univr.it",{"type":35,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Andrea Ruzzenente","Professor","100617996","supra-papillary-versus-trans-papillary-biliary-stenting-in-malignant-peri-hilar-stenosis-100617996",false,"NCT07325877","Supra-papillary Versus Trans-papillary Biliary Stenting in Malignant Peri-hilar Stenosis","Supra-papillary Versus Trans-papillary Biliary Stenting in Malignant Peri-hilar Stenosis (SupraBilS): a Randomized Controlled Trial","SupraBilS","Inclusion Criteria:\n\n1. Radiological\u002F biochemical\u002Fpathological diagnosis of malignant OJ.\n2. Stenosis maximum extent may be 2 cm after biliary confluence.\n3. Documented obstructive jaundice (serum bilirubin \\> 3 mg\u002FdL).\n4. Indication for biliary drainage (preoperative or palliative).\n5. Age ≥ 18 years.\n6. Signed informed consent.\n\nExclusion Criteria:\n\n1. Contraindications to endoscopic approach (duodenal stenosis, surgically altered anatomy).\n2. Previous sphincterotomy or drainage.\n3. Involvement of the papilla of Vater by the tumour.\n4. Uncontrolled coagulopathy (INR \\> 1.5 uncorrectable or \\\u003C50.000 PLTs).\n5. Ongoing uncontrolled cholangitis as defined according to the Tokyo 2018 Guidelines, or systemic sepsis.","ALL","18 Years",{"count":68,"type":69},70,"ESTIMATED","INTERVENTIONAL",[72],"NA","This is a randomized controlled trial comparing patients with obstructive jaundice due to malignancies of the perihilar area of bile ducts and undergoing both preoperative and palliative biliary drainage. The comparison will focus on the technique:, on the one hand, an arm of patients undergoing standard-of-care ERCP with trans-papillary plastic protesis placement, and on the other hand, an experimental arm of patients undergoing suprapapillary plastic protesis placement with no sphincterotomy. The primary objective will be to compare the time-to-stent dysfunction in the two groups; secondary objectives will include a comparison of the safety, technical, and clinical success of the procedures.",[75,76,77],"Biliary Disease Tract","Biliary Stenosis","Biliary Stents",[79,80,81,82],"ERCP","Malignant Biliary Stenosis","Supra-papillary","Trans-Papillary","NOT_YET_RECRUITING","2026-01-03",{"date":86,"type":87},"2026-01-08","ACTUAL",{"date":89,"type":69},"2026-03-01",{"date":91,"type":69},"2029-03-01",{"name":5,"class":6}]