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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Leipzig

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

258 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Leipzig

Lead sponsor

Zentrum für Klinische Studien Leipzig

Collaborator