About this trial
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.
Eligibility criteria
Qualifiers
Hilar cholangiocarcinoma (cytological or histological confirmation)
Surgery is not planned
Age ≥ 18 years
Written informed consent
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Photosensitizer
- Radiofrequency ablation (RFA)
Treatment groups
Sponsors and collaborators
University of Leipzig
Lead sponsor
Zentrum für Klinische Studien Leipzig
Collaborator