[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100617996":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":26,"studyPopulation":26,"armGroups":36,"interventions":49,"overallOfficials":59,"centralContacts":73,"locations":26,"responsibleParty":82,"collaborators":26,"id":85,"slug":26,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":86,"sex":92,"minAge":93,"maxAge":26,"enrollmentInfo":94,"targetDuration":26,"studyType":97,"phases":98,"briefSummary":100,"conditions":101,"keywords":105,"overallStatus":110,"whyStopped":26,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":26},{"fullName":5,"class":6},"Azienda Ospedaliera Universitaria Integrata Verona","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":26},[9],{"measure":10,"description":11,"timeFrame":12},"Time-to-Stent disfunction","In days, calculated from the index procedure. Stent(s) dysfunction, which includes occlusion or migration of the stent(s) and tumour ingrowth\u002Fovergrowth, is defined as the presence of at least two of the following three criteria:\n\n1. New dilation of the biliary tree on imaging:\n2. Bilirubin level above 2 mg\u002FdL (34.2 mmol\u002FL) with a new increase ≥ 1 mg\u002FdL compared with the value after initial clinical success, or elevation of alkaline phosphatase and\u002For g-glutamyl transferase greater than 2 times the upper normal limit with a new elevation of 30 U\u002FL\n3. Cholangitis, characterized by fever along with leucocytosis (\\> 10,000\u002FmL) or C-reactive protein levels above 20 mg\u002FdL.","From index procedure to a minimum of one year of follow up.",[14,18,22],{"measure":15,"description":16,"timeFrame":17},"Safety of the procedure","The incidence of Adverse events and severe adverse events will be compared. Adverse events (AEs) (timepoint 14 days) are defined according to the ASGE lexicon and graded according to the Adverse Events in GI endoscopy (AGREE) classification that classifies AEs in 5 grades from Grade I, any deviation from standard postprocedural course without need for pharmacological or interventional treatment, to Grade V, death of the patient. Sub-group analysis will be performed for procedure-related AEs. Severe adverse events are defined as AGREE≥3.","From the index procedure within 14 days.",{"measure":19,"description":20,"timeFrame":21},"Technical success","Defined as the placement of the stent(s) in the desired position (timepoint 0)","At the moment of index procedure.",{"measure":23,"description":24,"timeFrame":25},"Clinical Success","Defined as the reduction of bilirubin level ≥50% or at a level \\\u003C2 mg\u002FdL (34.2 mmol\u002FL).","Between 14 and 30 days from the index procedure.",null,{"allocation":28,"interventionModel":29,"interventionModelDescription":30,"primaryPurpose":31,"observationalModel":26,"timePerspective":26,"maskingInfo":32},"RANDOMIZED","PARALLEL","This is a single-blinded randomized controlled trial comparing two techniques used for the same procedure (ERCP and biliary stenting, suprapapillary vs transpapillary placement).","TREATMENT",{"masking":33,"maskingDescription":26,"whoMasked":34},"SINGLE",[35],"PARTICIPANT",[37,43],{"label":38,"type":39,"description":40,"interventionNames":41},"Suprapapillary","EXPERIMENTAL","ERCP for malignant stenosis of bile duct with suprapapillary stents positioning (experimental)",[42],"Procedure: ERCP with suprapapillary stent placement",{"label":44,"type":45,"description":46,"interventionNames":47},"Trans Papillary","ACTIVE_COMPARATOR","ERCP for malignant stenosis of bile duct with transpapillary stents positioning (Standard of care).",[48],"Procedure: ERCP with transpapillary stent placement",[50,55],{"type":51,"name":52,"description":53,"armGroupLabels":54,"otherNames":26},"PROCEDURE","ERCP with suprapapillary stent placement","ERCP with no sphincterotomy and placement of plastic stents above the papilla of Vater.",[38],{"type":51,"name":56,"description":57,"armGroupLabels":58,"otherNames":26},"ERCP with transpapillary stent placement","Standard ERCP with or without sphincterotomy with trans papillary stent placement",[44],[60,64,67,71],{"name":61,"affiliation":62,"role":63},"Andrea Ruzzenente, Professor","Integrated University Hospital Verona","PRINCIPAL_INVESTIGATOR",{"name":65,"affiliation":62,"role":66},"Stefano Francesco Crinò, Consultant","STUDY_DIRECTOR",{"name":68,"affiliation":69,"role":70},"Edoardo Poletto, PhD Candidate, Consultant","Integrated university Hospital Verona","STUDY_CHAIR",{"name":72,"affiliation":62,"role":70},"Maria Cristina Conti Bellocchi, Consultant",[74,78],{"name":61,"role":75,"phone":76,"phoneExt":26,"email":77},"CONTACT","+39 0458124644","andrea.ruzzenente@univr.it",{"name":79,"role":75,"phone":80,"phoneExt":26,"email":81},"Edoardo Poletto, PhD Candidate - Consultant","+39 3452308635","edoardo.poletto@univr.it",{"type":63,"investigatorFullName":83,"investigatorTitle":84,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Andrea Ruzzenente","Professor","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":95,"type":96},70,"ESTIMATED","INTERVENTIONAL",[99],"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.",[102,103,104],"Biliary Disease Tract","Biliary Stenosis","Biliary Stents",[106,107,108,109],"ERCP","Malignant Biliary Stenosis","Supra-papillary","Trans-Papillary","NOT_YET_RECRUITING","2026-01-03",{"date":113,"type":114},"2026-01-08","ACTUAL",{"date":116,"type":96},"2026-03-01",{"date":118,"type":96},"2029-03-01",{"name":5,"class":6}]