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

Trial details

Who runs it

University of Leipzig

Trial code

NCT05551299EU 2022-500107-50-00

Record updated

2025. március 27.

Original description

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.Read full original descriptionShow less

Cholangiocarcinoma Treatment with Radiofrequency Ablation or Photodynamic Therapy: a Randomized Controlled 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.

Inclusion: Hilar cholangiocarcinoma (cytological or histological confirmation); Surgery is not planned; Age ≥ 18 years; Written informed consent.

Exclusion: 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); Known hypersensitivity to porphyrins or to any of the other ingredients of the photosensitizer chosen; 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; Tumour not accessible endoscopically; Leukopenia (< 2000/mm3); Thrombocytopenia (< 100,000 / mm³); Severe, uncorrected coagulopathy (at the discretion of the physician); 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); Participation in other interventional trials; Patients under legal supervision or guardianship; Pregnant or nursing women.

ClinicalTrials.gov NCT05551299 · EU CTIS 2022-500107-50-00