[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100481236":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":29,"locations":35,"responsibleParty":51,"collaborators":55,"id":81,"slug":11,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":82,"sex":88,"minAge":89,"maxAge":11,"enrollmentInfo":90,"targetDuration":11,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":99,"overallStatus":38,"whyStopped":11,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Endobiliary RFA + stent placement","EXPERIMENTAL",null,[13,14],"Device: Endobiliary radiofrequency ablation (eRFA)","Device: uncovered self-expanding metal stent (uSEMS)",{"label":16,"type":17,"description":11,"interventionNames":18},"Stent placement only","ACTIVE_COMPARATOR",[14],[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DEVICE","Endobiliary radiofrequency ablation (eRFA)","Intraductal radiofrequency ablation of tumor prior to stent placement",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"uncovered self-expanding metal stent (uSEMS)","Intraductal placement of uncovered metal stent",[9,16],[30],{"name":31,"role":32,"phone":33,"phoneExt":11,"email":34},"Esmée Smit","CONTACT","+31204440613","e.smit1@amsterdamumc.nl",[36],{"facility":37,"status":38,"city":39,"state":11,"zip":40,"country":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Amsterdam UMC location VUmc","RECRUITING","Amsterdam","1081HV","Netherlands",{"type":43,"coordinates":44},"Point",[45,46],4.88969,52.37403,{"lat":46,"lon":45},[49],{"name":50,"role":32,"phone":11,"phoneExt":11,"email":34},"Esmée Smit, MD",{"type":52,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Rogier P. Voermans","Principal Investigator",[56,58,60,62,64,66,68,70,72,75,77,79],{"name":57,"class":6},"Erasmus Medical Center",{"name":59,"class":6},"Leiden University Medical Center",{"name":61,"class":6},"UMC Utrecht",{"name":63,"class":6},"University Medical Center Groningen",{"name":65,"class":6},"St. Antonius Hospital",{"name":67,"class":6},"Medisch Spectrum Twente",{"name":69,"class":6},"Maastricht University Medical Center",{"name":71,"class":6},"Clinical Hospital Colentina",{"name":73,"class":74},"University Hospital Prague (IKEM), Prague, Czech Republic","UNKNOWN",{"name":76,"class":6},"Orlando Health, Inc.",{"name":78,"class":6},"University Hospital, Ghent",{"name":80,"class":6},"Universitaire Ziekenhuizen KU Leuven","100481236",false,"NCT05546372","Endobiliary Radiofrequency Ablation for Malignant Biliary Obstruction Due to Perihilar Cholangiocarcinoma","Endobiliary Radiofrequency Ablation for Malignant Biliary Obstruction Due to Perihilar Cholangiocarcinoma: a Randomized Controlled Trial","RACCOON","Inclusion Criteria:\n\n* 18 years or older.\n* Capable of providing written and oral informed consent.\n* Histological or cytological proof of perihilar CCA (adenocarcinoma).\n* Perihilar biliary obstruction with an indication for drainage with uSEMS.\\*\n* Advanced (no candidate for surgical resection) due to metastases, vascular or lymph node (N2) involvement on imaging or during staging laparoscopy according to multidisciplinary team (MDT).\n\n  * Only patients with pCCA are eligible however in case of reasonable doubt between intrahepatic CCA with a perihilar biliary obstruction or massforming pCCA, patients can be included.\n\nExclusion Criteria:\n\n* Patients who potentially qualify for curative resection of pCCA.\n* pCCA eligible for liver transplantation.\n* Life-expectancy less than 3 months.\n* ERCP and PTC technically not feasible.\n* Uncontrolled coagulopathy (PTT \\>1,5x prolonged or thrombocytes below 40\\*10E9\u002FL).\n* Ongoing cholangitis or liver abscess. Patients are required to be off antibiotic treatment for cholangitis and\u002For liver abscess at least 7 days.\n* Any condition that is unstable or that could jeopardize the safety of the subject and their compliance in the study.\n* Patients who are pregnant or breastfeeding.","ALL","18 Years",{"count":91,"type":92},122,"ESTIMATED","INTERVENTIONAL",[95],"NA","A multicentre, parallel group, open label, randomized controlled trial comparing endobiliary RFA prior to metal stent placement with stent placement only in patients with inoperable perihilar cholangiocarcinoma.",[98],"Perihilar Cholangiocarcinoma",[100,101],"Endobiliary radiofrequency ablation","Stent patency","2026-05-21",{"date":104,"type":105},"2026-05-26","ACTUAL",{"date":107,"type":105},"2022-10-22",{"date":109,"type":92},"2027-06-30",{"name":5,"class":6},1]