[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100402702":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":29,"locations":34,"responsibleParty":113,"collaborators":18,"id":117,"slug":118,"hasResults":119,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":123,"eligibilityCriteria":124,"healthyVolunteers":119,"sex":125,"minAge":126,"maxAge":18,"enrollmentInfo":127,"targetDuration":18,"studyType":130,"phases":131,"briefSummary":133,"conditions":134,"keywords":136,"overallStatus":37,"whyStopped":18,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":149},{"fullName":5,"class":6},"Kantonsspital Aarau","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental Intervention (treatment)","EXPERIMENTAL","Open bile ducts are identified by visual control of the liver resection surface combined with the direct injection in the cystic stump of 20-40ml of SMOFlipid 20% Fresenius Kabi Canada Ltd.; authorization number: 57231 (Swissmedic).\n\nSMOFlipid is a white oily emulsion containing soya oil and medium chain triglycerides as main active components, normally used as parenteral nutrition as complement for essential fat acids supplementation. In this study the \"white\" test (= the administration of SMOFlipid retrograde through the cystic duct) is made by injection of one or two 20cc syringes full of lipidic solution (SMOFlipid 20%) in the cystic stump, directing the flow to the intrahepatic ducts. Residual fat emulsion is washed out from the biliary tract by a low pressure infusion of 20 to 50 ml of saline solution.",[13],"Drug: \"white\" test\" (= the administration of SMOFlipid retrograde through the cystic duct)",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Intervention","NO_INTERVENTION","Open bile ducts are identified in the control group by visual control of the liver resection surface combined with the use of white gauzes (standard procedure)",null,[20],{"type":21,"name":22,"description":22,"armGroupLabels":23,"otherNames":18},"DRUG","\"white\" test\" (= the administration of SMOFlipid retrograde through the cystic duct)",[9],[25],{"name":26,"affiliation":27,"role":28},"Giulia Manzini, Dr. med.","Cantonal Hospital of Aarau, Switzerland","PRINCIPAL_INVESTIGATOR",[30],{"name":26,"role":31,"phone":32,"phoneExt":18,"email":33},"CONTACT","+41-62-8389734","giulia.manzini@ksa.ch",[35,52,67,82,97],{"facility":36,"status":37,"city":38,"state":18,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Department of Visceral Surgery, Cantonal Hospital of Aarau","RECRUITING","Aarau","5001","Switzerland","CH",{"type":43,"coordinates":44},"Point",[45,46],8.04422,47.39254,{"lat":46,"lon":45},[49,51],{"name":26,"role":31,"phone":50,"phoneExt":18,"email":33},"062-8389734",{"name":26,"role":28,"phone":18,"phoneExt":18,"email":18},{"facility":53,"status":37,"city":54,"state":18,"zip":55,"country":40,"countryCode":41,"cosmosGeoPoint":56,"geoPoint":60,"contacts":61},"Clarunis Basel, Universitäres Bauchzentrum Basel","Basel","4031",{"type":43,"coordinates":57},[58,59],7.57327,47.55839,{"lat":59,"lon":58},[62,66],{"name":63,"role":31,"phone":64,"phoneExt":18,"email":65},"Otto Kollmar, Prof. Dr. med.","+41 61 777 73 20","otto.kollmar@clarunis.ch",{"name":63,"role":28,"phone":18,"phoneExt":18,"email":18},{"facility":68,"status":37,"city":69,"state":18,"zip":70,"country":40,"countryCode":41,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"Kantonsspital Luzern","Lucerne","6004",{"type":43,"coordinates":72},[73,74],8.30635,47.05048,{"lat":74,"lon":73},[77,81],{"name":78,"role":31,"phone":79,"phoneExt":18,"email":80},"Andreas Scheiwiller, Dr. med.","041 2054539","andreas.scheiwiller@luks.ch",{"name":78,"role":28,"phone":18,"phoneExt":18,"email":18},{"facility":83,"status":37,"city":84,"state":18,"zip":85,"country":40,"countryCode":41,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"Ospedale Regionale di Lugano","Lugano","6900",{"type":43,"coordinates":87},[88,89],8.96004,46.01008,{"lat":89,"lon":88},[92,96],{"name":93,"role":31,"phone":94,"phoneExt":18,"email":95},"Alessandra Cristaudi, Dr. med.","091 811 7208","alessandra.cristaudi@eoc.ch",{"name":93,"role":28,"phone":18,"phoneExt":18,"email":18},{"facility":98,"status":37,"city":99,"state":18,"zip":100,"country":40,"countryCode":41,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"Kantonsspital St. Gallen","Sankt Gallen","9001",{"type":43,"coordinates":102},[103,104],9.37477,47.42391,{"lat":104,"lon":103},[107,111],{"name":108,"role":31,"phone":109,"phoneExt":18,"email":110},"Ignazio Tarantino, PD Dr. med.","071 4941312","Ignazio.tarantino@kssg.ch",{"name":112,"role":28,"phone":18,"phoneExt":18,"email":18},"Ignazio Tarantino, PD Dr. med",{"type":114,"investigatorFullName":115,"investigatorTitle":116,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"SPONSOR_INVESTIGATOR","Giulia Manzini","Dr. med., Senior physician, Department of Visceral Surgery","100402702","phase-3-diagnostic-role-of-the-white-test-with-lipidic-solution-in-the-early-intraoperative-identification-of-open-bile-ducts-for-the-prevention-of-bile-leakage-after-liver-resection-bile--trial-100402702",false,"NCT04523701","Diagnostic Role of the \"White Test\" With Lipidic Solution in the Early Intraoperative Identification of Open Bile Ducts for the Prevention of Bile Leakage After Liver Resection (BiLe -Trial)","Diagnostic Role of the \"White Test\" With Lipidic Solution in the Early Intraoperative Identification of Open Bile Ducts for the Prevention of Bile Leakage After Liver Resection- A Randomized Controlled Multicentric Superiority Trial- The BiLe-Trial (Bile Leakage Trial)","BiLe","Inclusion Criteria:\n\n* Patients who will receive an anatomical resection of two or more liver segments for any reason with simultaneous cholecystectomy in elective Setting\n* Patients who will receive an anatomical resection of two or more liver segments for any reason which already had a cholecystectomy if intraoperatively the cystic stump can be identified and opened\n* Ability of subject to understand character and individual consequences of the clinical Trial\n* Informed consent documented by signature\n\nExclusion Criteria:\n\n* Previous cholecystectomy if intraoperative it is not possible to identify the cystic stump\n* Intraoperative hepatico-jejunostomy\n* Hypersensitivity to fish-, egg-, soybean or peanut protein or to any of the active ingredients or excipients\n* Immunosuppression, pregnancy\n* Emergency liver resection because of traumatic liver rupture\n* Enrolment of the investigator, his\u002Fher family members, employees and other dependent persons","ALL","18 Years",{"count":128,"type":129},210,"ESTIMATED","INTERVENTIONAL",[132],"PHASE3","Bile leakage (BL) is the most frequent complication after liver resection. This study is to investigate the role of intraoperative administration of SMOFlipid 20% (fat emulsion which allows intraoperative identification of open bile ducts at the liver resection surface when it is administered retrograde through the cystic duct) in terms of prevention of postoperative BL within 30 days after surgery.",[135],"Bile Leakage",[137,138,139],"Liver resection","SMOFlipid 20%","White Test","2025-03-11",{"date":142,"type":143},"2025-03-14","ACTUAL",{"date":145,"type":143},"2021-03-25",{"date":147,"type":129},"2025-12",{"name":115,"class":6},5]