[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100481614":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":31,"centralContacts":36,"locations":45,"responsibleParty":311,"collaborators":314,"id":317,"slug":318,"hasResults":319,"nctId":320,"briefTitle":321,"officialTitle":322,"acronym":323,"eligibilityCriteria":324,"healthyVolunteers":319,"sex":325,"minAge":326,"maxAge":30,"enrollmentInfo":327,"targetDuration":30,"studyType":330,"phases":331,"briefSummary":333,"conditions":334,"keywords":336,"overallStatus":48,"whyStopped":30,"lastUpdateSubmitDate":339,"lastUpdatePostDateStruct":340,"startDateStruct":343,"completionDateStruct":345,"leadSponsor":347,"locationsCount":348},{"fullName":5,"class":6},"University of Leipzig","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Photodynamic therapy (PDT)","EXPERIMENTAL","The index procedure in all patients at baseline includes stenting, using an endoscopic retrograde cholangio-pancreatography (ERCP) procedure. The Intervention is at least one PDT at baseline according to the clinical routine of the trial site.",[13],"Drug: Photosensitizer",{"label":15,"type":10,"description":16,"interventionNames":17},"Radiofrequency ablation (RFA)","The index procedure in all patients at baseline includes stenting, using an endoscopic retrograde cholangio-pancreatography (ERCP) procedure. The Intervention is at least one RFA at baseline according to the clinical routine of the trial site.",[18],"Procedure: Radiofrequency ablation (RFA)",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Photosensitizer","A photosensitizer, which is absorbed preferentially by tumour cells, is administered 24 - 48 hours prior to PDT. Light of a particular wavelength is then applied during endoscopic retrograde cholangiopancreatography (ERCP) to kill primarily cancer cells locally within the stenosis. Immediately after PDT treatment, new stents are inserted into all treated segments if needed.",[9],[9],{"type":27,"name":15,"description":28,"armGroupLabels":29,"otherNames":30},"PROCEDURE","RFA is also carried out as part of an ERCP. The RFA-probe is placed within the tumour stenosis and electrical current is applied. New stents are inserted into all treated segments if needed.",[15],null,[32],{"name":33,"affiliation":34,"role":35},"Albrecht Hoffmeister, Prof.Dr.med.","Universitätsklinikum Leipzig; Bereich Gastroenterologie","PRINCIPAL_INVESTIGATOR",[37,41],{"name":33,"role":38,"phone":39,"phoneExt":30,"email":40},"CONTACT","+49-341-97-12240","albrecht.hoffmeister@medizin.uni-leipzig.de",{"name":42,"role":38,"phone":43,"phoneExt":30,"email":44},"Marcus Hollenbach, Dr. med.","+49-341-97-12362","marcus.hollenbach@medizin.uni-leipzig.de",[46,64,77,91,105,117,129,142,156,169,183,196,206,220,230,243,257,271,284,297],{"facility":47,"status":48,"city":49,"state":30,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Uniklinik RWTH Aachen, Medizinische Klinik III","RECRUITING","Aachen","52074","Germany","DE",{"type":54,"coordinates":55},"Point",[56,57],6.08342,50.77664,{"lat":57,"lon":56},[60],{"name":61,"role":38,"phone":62,"phoneExt":30,"email":63},"Karim Hamesch, PD Dr.","+49 241 80 80861","khamesch@ukaachen.de",{"facility":65,"status":48,"city":66,"state":30,"zip":67,"country":51,"countryCode":52,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"Universitätsklinikum Augsburg; III. Med. Klinik","Augsburg","86156",{"type":54,"coordinates":69},[70,71],10.89851,48.37154,{"lat":71,"lon":70},[74],{"name":75,"role":38,"phone":30,"phoneExt":30,"email":76},"Tobias Weber, Dr.","tobias.weber@uk-augsburg.de",{"facility":78,"status":79,"city":80,"state":30,"zip":81,"country":51,"countryCode":52,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"Vivantes Netzwerk für Gesundheit GmbH, Klinikum Friedrichshain, Innere Medizin\u002FGastroenterologie","NOT_YET_RECRUITING","Berlin","10249",{"type":54,"coordinates":83},[84,85],13.41053,52.52437,{"lat":85,"lon":84},[88],{"name":89,"role":38,"phone":30,"phoneExt":30,"email":90},"Thomas Brunk, Dr.","thomas.brunk@vivantes.de",{"facility":92,"status":48,"city":93,"state":30,"zip":94,"country":51,"countryCode":52,"cosmosGeoPoint":95,"geoPoint":99,"contacts":100},"Universitatsklinikum Bonn, Medizinische Klinik und Poliklinik I","Bonn","53127",{"type":54,"coordinates":96},[97,98],7.09549,50.73438,{"lat":98,"lon":97},[101],{"name":102,"role":38,"phone":103,"phoneExt":30,"email":104},"Dominik Kaczmarek, Dr.","+49 228 287 -15263","Dominik.Kaczmarek@ukbonn.de",{"facility":106,"status":79,"city":107,"state":30,"zip":108,"country":51,"countryCode":52,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"Universitätsklinikum Frankfurt, Medizinische Klinik 1","Frankfurt","60590",{"type":54,"coordinates":110},[111,112],10.53333,49.68333,{"lat":112,"lon":111},[115],{"name":116,"role":38,"phone":30,"phoneExt":30,"email":30},"Jörg Trojan, Prof. Dr.",{"facility":118,"status":48,"city":119,"state":30,"zip":120,"country":51,"countryCode":52,"cosmosGeoPoint":121,"geoPoint":125,"contacts":126},"Universitätsklinikum Freiburg, Medizinische Klinik II, Abteilung Gastroenterologie, Hepatologie, Endokrinologie & lnfektiologie","Freiburg im Breisgau","79106",{"type":54,"coordinates":122},[123,124],7.85222,47.9959,{"lat":124,"lon":123},[127],{"name":128,"role":38,"phone":30,"phoneExt":30,"email":30},"Armin Küllmer, Dr.",{"facility":130,"status":48,"city":131,"state":30,"zip":132,"country":51,"countryCode":52,"cosmosGeoPoint":133,"geoPoint":137,"contacts":138},"Universitätsmedizin Greifswald Klinik für Innere Medizin A","Greifswald","17475",{"type":54,"coordinates":134},[135,136],13.40244,54.08905,{"lat":136,"lon":135},[139],{"name":140,"role":38,"phone":30,"phoneExt":30,"email":141},"Ali Aghdassi, Prof.","Ali.Aghdassi@med.uni-greifswald.de",{"facility":143,"status":48,"city":144,"state":30,"zip":145,"country":51,"countryCode":52,"cosmosGeoPoint":146,"geoPoint":150,"contacts":151},"Site: Martin-Luther-Universitat Halle-Wittenberg, Universitätsklinik und Poliklinik für Innere Medizin I","Halle","06120",{"type":54,"coordinates":147},[148,149],11.97947,51.48158,{"lat":149,"lon":148},[152],{"name":153,"role":38,"phone":154,"phoneExt":30,"email":155},"Jonas Rosendahl, Prof. Dr.","+49 345 557 2661","jonas.rosendahl@uk-halle.de",{"facility":157,"status":48,"city":158,"state":30,"zip":159,"country":51,"countryCode":52,"cosmosGeoPoint":160,"geoPoint":164,"contacts":165},"Klinikum Hanau; Klinik für Gastroenterologie, Diabetologie und Infektiologie","Hanau","63450",{"type":54,"coordinates":161},[162,163],8.91418,50.13423,{"lat":163,"lon":162},[166],{"name":167,"role":38,"phone":30,"phoneExt":30,"email":168},"Likas Welsch, Dr.","Lukas_Welsch@klinikum-hanau.de",{"facility":170,"status":48,"city":171,"state":30,"zip":172,"country":51,"countryCode":52,"cosmosGeoPoint":173,"geoPoint":177,"contacts":178},"KRH Klinikum Siloah, Klinik für Gastroenterologie","Hanover","30459",{"type":54,"coordinates":174},[175,176],9.73322,52.37052,{"lat":176,"lon":175},[179],{"name":180,"role":38,"phone":181,"phoneExt":30,"email":182},"Daniel Vidacek, Dr.","+49 511 927 2102","Daniel.Vidacek@krh.de",{"facility":184,"status":48,"city":185,"state":30,"zip":186,"country":51,"countryCode":52,"cosmosGeoPoint":187,"geoPoint":191,"contacts":192},"Klinikum St. Georg gGmbH; Klinik für Gastroenterologie, Hepatologie, Diabetologie und Endokrinologie","Leipzig","04109",{"type":54,"coordinates":188},[189,190],12.37129,51.33962,{"lat":190,"lon":189},[193],{"name":194,"role":38,"phone":30,"phoneExt":30,"email":195},"Ingolf Schiefke, Prof.","ingolf.schiefke@SanktGeorg.de",{"facility":197,"status":48,"city":185,"state":30,"zip":30,"country":51,"countryCode":52,"cosmosGeoPoint":198,"geoPoint":200,"contacts":201},"University Hospital of Leipzig, Department of Gastroenterology",{"type":54,"coordinates":199},[189,190],{"lat":190,"lon":189},[202],{"name":203,"role":38,"phone":204,"phoneExt":30,"email":205},"Albrecht Hoffmeister, Prof. Dr.","++49 - 341 - 97 12240","Albrecht.Hoffmeister@medizin.uni-leipzig.de",{"facility":207,"status":48,"city":208,"state":30,"zip":209,"country":51,"countryCode":52,"cosmosGeoPoint":210,"geoPoint":214,"contacts":215},"RKH Kliniken Ludwigsburg- Bietigheim gGmbH, Klinik für Innere Medizin, Gastroenterologie, Hämato-Onkologie, Diabetologie und Infektiologie","Ludwigsburg","71640",{"type":54,"coordinates":211},[212,213],9.19161,48.89731,{"lat":213,"lon":212},[216],{"name":217,"role":38,"phone":218,"phoneExt":30,"email":219},"Andreas Wannhoff, Dr.","+4971419967201","andreas.wannhoff@rkh-kliniken.de",{"facility":221,"status":222,"city":223,"state":30,"zip":224,"country":51,"countryCode":52,"cosmosGeoPoint":225,"geoPoint":229,"contacts":30},"Universitätsmedizin Mannheim, II. Medizinische Klinik","WITHDRAWN","Mannheim","68167",{"type":54,"coordinates":226},[227,228],8.46694,49.4891,{"lat":228,"lon":227},{"facility":231,"status":48,"city":232,"state":30,"zip":233,"country":51,"countryCode":52,"cosmosGeoPoint":234,"geoPoint":238,"contacts":239},"Universitätsklinikum Gießen und Marburg GmbH (UKGM); Klinik für Innere Medizin mit den Schwerpunkten Gastroenterologie, Endokrinologie, Stoffwechsel und klinische Infektiologie","Marburg","35043",{"type":54,"coordinates":235},[236,237],8.77069,50.80904,{"lat":237,"lon":236},[240],{"name":241,"role":38,"phone":30,"phoneExt":30,"email":242},"Ulrike Denzer, Prof.","ulrike.denzer@uk-gm.de",{"facility":244,"status":48,"city":245,"state":30,"zip":246,"country":51,"countryCode":52,"cosmosGeoPoint":247,"geoPoint":251,"contacts":252},"Klinikum der LMU München, Medizinische Klinik II, Campus Großhadern","München","81377",{"type":54,"coordinates":248},[249,250],13.31243,51.60698,{"lat":250,"lon":249},[253],{"name":254,"role":38,"phone":255,"phoneExt":30,"email":256},"Jörg Schirra, Prof. Dr.","+49 89 4400 73031","joerg.schirra@med.uni-muenchen.de",{"facility":258,"status":48,"city":259,"state":30,"zip":260,"country":51,"countryCode":52,"cosmosGeoPoint":261,"geoPoint":265,"contacts":266},"Universitlitsklinikum Munster Medizinische Klinik B (Gastroenterologie, Hepatologie, Endokrinologie, Klinische lnfektiologie)","Münster","48149",{"type":54,"coordinates":262},[263,264],7.62571,51.96236,{"lat":264,"lon":263},[267],{"name":268,"role":38,"phone":269,"phoneExt":30,"email":270},"Jonel Trebicka, Prof.","+492518343330","Jonel.Trebicka@ukmuenster.de",{"facility":272,"status":48,"city":273,"state":30,"zip":274,"country":51,"countryCode":52,"cosmosGeoPoint":275,"geoPoint":279,"contacts":280},"Klinikum Nürnberg Nord; Gastroenterologie\u002F Endokrinologie","Nuremberg","90419",{"type":54,"coordinates":276},[277,278],11.07752,49.45421,{"lat":278,"lon":277},[281],{"name":282,"role":38,"phone":30,"phoneExt":30,"email":283},"Alexander Dechêne, Prof.","Alexander.Dechene@klinikum-nuernberg.de",{"facility":285,"status":48,"city":286,"state":30,"zip":287,"country":51,"countryCode":52,"cosmosGeoPoint":288,"geoPoint":292,"contacts":293},"Robert-Bosch-Krankenhaus (RBK) Stuttgart; Gastroenterologie, Hepatologie und Endokrinologie","Stuttgart","70376",{"type":54,"coordinates":289},[290,291],9.17702,48.78232,{"lat":291,"lon":290},[294],{"name":295,"role":38,"phone":30,"phoneExt":30,"email":296},"Arthur Schmidt","arthur.schmidt@rbk.de",{"facility":298,"status":48,"city":299,"state":30,"zip":300,"country":51,"countryCode":52,"cosmosGeoPoint":301,"geoPoint":305,"contacts":306},"Universitätsklinikum Tübingen, Medizinische Klinik I","Tübingen","72076",{"type":54,"coordinates":302},[303,304],9.05222,48.52266,{"lat":304,"lon":303},[307],{"name":308,"role":38,"phone":309,"phoneExt":30,"email":310},"Christoph Werner, Dr.","+49 7071 2982712","christoph.werner@med.uni-tuebingen.de",{"type":35,"investigatorFullName":312,"investigatorTitle":313,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"Albrecht Hoffmeister","Prof. Dr. med.",[315],{"name":316,"class":6},"Zentrum für Klinische Studien Leipzig","100481614","phase-4-treatment-of-non-resectable-bile-duct-cancer-with-radiofrequency-ablation-or-photodynamic-therapy-100481614",false,"NCT05551299","Treatment of Non-resectable Bile Duct Cancer with Radiofrequency Ablation or Photodynamic Therapy","Cholangiocarcinoma Treatment with Radiofrequency Ablation or Photodynamic Therapy: a Randomized Controlled Trial","CARP","Inclusion Criteria:\n\n1. Hilar cholangiocarcinoma (cytological or histological confirmation)\n2. Surgery is not planned\n3. Age ≥ 18 years\n4. Written informed consent\n\nExclusion Criteria:\n\n1. Tumour not accessible endoscopically\n2. Known hypersensitivity to porphyrins or to any of the other ingredients of the photosensitizer chosen\n3. Leukopenia (\\\u003C 2000\u002Fmm3)\n4. Thrombocytopenia (\\\u003C 100,000 \u002F mm³)\n5. Severe, uncorrected coagulopathy (at the discretion of the physician)\n6. Suspected erosion of major blood vessels, because of the risk of life-threatening mass haemorrhage exists\n7. Porphyria (clinician's assessment) or other light-exacerbated diseases\n8. Severely impaired liver and or kidney function (at the discretion of the physician)\n9. Bedridden for more than 50% of the time (similar to ECOG (Eastern Cooperative Oncology Group) grade 3)\n10. Planned surgical procedure within the next 30 days\n11. Concurrent eye disease that will require a slit lamp examination within the next 30 days\n12. Prior radiotherapy within the last four weeks\n13. Previous PDT or RFA\n14. Planned liver transplantation\n15. Fertile women (within two years of their last menstruation) without appropriate contraceptive measures (implanon, injections, oral contraceptives, intrauterine devices, partner with vasectomy) while participating in the trial (participants using a hormone-based method have to be informed of possible effects of the trial medication on contraception)\n16. Participation in other interventional trials\n17. Patients under legal supervision or guardianship\n18. Pregnant or nursing women","ALL","18 Years",{"count":328,"type":329},258,"ESTIMATED","INTERVENTIONAL",[332],"PHASE4","Bile duct cancer is often diagnosed after curative options are no longer available. Stent therapy is used to keep the ducts open and can be combined with photodynamic therapy (PDT) to extend life expectancy. PDT requires an injection of photosensitizer after which light of a particular wavelength is applied endoscopically to kill the cancer cells. Drawbacks include not only high costs and poor availability, but foremost that patients have to avoid direct sunlight for a period of weeks. Radio frequency ablation (RFA) together with stent implantation constitutes an alternative by which the cancer cells are killed through heat, also applied endoscopically. The RFA technology is more widely available and easier to deploy. However, it has not been studied extensively and no randomized trials exist comparing the two methods. This trial will compare survival in patients with a particular bile duct cancer depending on whether they receive PDT or RFA. Moreover, data will be collected on side-effects and quality of life.",[335],"Hilar Cholangiocarcinoma",[335,15,9,22,337,338],"Klatskin Tumor","Bile Duct Cancer","2025-03-24",{"date":341,"type":342},"2025-03-27","ACTUAL",{"date":344,"type":342},"2023-02-10",{"date":346,"type":329},"2028-04",{"name":5,"class":6},20]