Treatment of Non-resectable Bile Duct Cancer With Radiofrequency Ablation or Photodynamic Therapy (CARP)
Hilar Cholangiocarcinoma
About this trial
This is an interventional treatment trial for Hilar Cholangiocarcinoma focused on measuring Hilar Cholangiocarcinoma, Radiofrequency ablation (RFA), Photodynamic therapy (PDT), Photosensitizer, Klatskin Tumor, Bile Duct Cancer
Eligibility Criteria
Inclusion Criteria:
- Hilar cholangiocarcinoma (cytological or histological confirmation)
- Surgery is not planned
- Age ≥ 18 years
- Written informed consent
Exclusion Criteria:
- Tumour not accessible endoscopically
- Known hypersensitivity to porphyrins or to any of the other ingredients of the photosensitizer chosen
- Leukopenia (< 2000/mm3)
- Thrombocytopenia (< 100,000 / mm³)
- Severe, uncorrected coagulopathy (at the discretion of the physician)
- Suspected erosion of major blood vessels, because of the risk of life-threatening mass haemorrhage exists
- Porphyria (clinician's assessment) or other light-exacerbated diseases
- Severely impaired liver and or kidney function (at the discretion of the physician)
- Bedridden for more than 50% of the time (similar to ECOG (Eastern Cooperative Oncology Group) grade 3)
- Planned surgical procedure within the next 30 days
- Concurrent eye disease that will require a slit lamp examination within the next 30 days
- Prior radiotherapy within the last four weeks
- Previous PDT or RFA
- Planned liver transplantation
- 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)
- Participation in other interventional trials
- Patients under legal supervision or guardianship
- Pregnant or nursing women
Sites / Locations
- Universitatsklinikum Bonn, Medizinische Klinik und Poliklinik IRecruiting
- Universitätsklinikum Frankfurt, Medizinische Klinik 1
- Universitätsklinikum Freiburg, Medizinische Klinik II, Abteilung Gastroenterologie, Hepatologie, Endokrinologie & lnfektiologie
- Site: Martin-Luther-Universitat Halle-Wittenberg, Universitätsklinik und Poliklinik für Innere Medizin IRecruiting
- University Hospital of Leipzig, Department of GastroenterologyRecruiting
- RKH Kliniken Ludwigsburg- Bietigheim gGmbH, Klinik für Innere Medizin, Gastroenterologie, Hämato-Onkologie, Diabetologie und InfektiologieRecruiting
- Universitätsmedizin Mannheim, II. Medizinische KlinikRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Photodynamic therapy (PDT)
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 PDT at baseline according to the clinical routine of the trial site.
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.