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Treatment of Non-resectable Bile Duct Cancer with Radiofrequency Ablation or Photodynamic Therapy

RecruitingPhase 4Ages 18 Years - anyAllUniversity of Leipzig
NCT05551299 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 d

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Hilar cholangiocarcinoma (cytological or histological confirmation) 2. Surgery is not planned 3. Age ≥ 18 years 4. Written informed consent Exclusion Criteria: 1. Tumour not accessible endoscopically 2. Known hypersensitivity to porphyrins or to any of the other ingredients of the photosensitizer chosen 3. Leukopenia (\< 2000/mm3) 4. Thrombocytopenia (\< 100,000 / mm³) 5. Severe, uncorrected coagulopathy (at the discretion of the physician) 6. Suspected erosion of major blood vessels, because of the risk of life-threatening mass haemorrhage exists 7. Porphyria (clinician's assessment) or other light-exacerbated diseases 8. Severely impaired liver and or kidney function (at the discretion of the physician) 9. Bedridden for more than 50% of the time (similar to ECOG (Eastern Cooperative Oncology Group) grade 3) 10. Planned surgical procedure within the next 30 days 11. Concurrent eye disease that will require a slit lamp examination within the next 30 days 12. Prior radiotherapy within the last four weeks 13. Previous PDT or RFA 14. Planned liver transplantation 15. 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) 16. Participation in other interventional trials 17. Patients under legal supervision or guardianship 18. Pregnant or nursing women
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What it tests

  • Photosensitizer
  • Radiofrequency ablation (RFA)
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Where

20 sites
Uniklinik RWTH Aachen, Medizinische Klinik III
Aachen, Germany
Universitätsklinikum Augsburg; III. Med. Klinik
Augsburg, Germany
Vivantes Netzwerk für Gesundheit GmbH, Klinikum Friedrichshain, Innere Medizin/Gastroenterologie
Berlin, Germany
Universitatsklinikum Bonn, Medizinische Klinik und Poliklinik I
Bonn, Germany
Universitätsklinikum Frankfurt, Medizinische Klinik 1
Frankfurt, Germany
Universitätsklinikum Freiburg, Medizinische Klinik II, Abteilung Gastroenterologie, Hepatologie, Endokrinologie & lnfektiologie
Freiburg im Breisgau, Germany
Universitätsmedizin Greifswald Klinik für Innere Medizin A
Greifswald, Germany
Site: Martin-Luther-Universitat Halle-Wittenberg, Universitätsklinik und Poliklinik für Innere Medizin I
Halle, Germany

…and 12 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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