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.
Hilar cholangiocarcinoma (cytological or histological confirmation)
Surgery is not planned
Age ≥ 18 years
Written informed consent
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)
Parallel
Photosensitizer
DrugA photosensitizer, which is absorbed preferentially by tumour cells, is administered 24 - 48 hours prior to PDT. Light of a particular wavelength is then applied during endoscopic retrograde cholangiopancreatography (ERCP) to kill primarily cancer cells locally within the stenosis. Immediately after PDT treatment, new stents are inserted into all treated segments if needed.
Radiofrequency ablation (RFA)
Procedure/SurgeryRFA is also carried out as part of an ERCP. The RFA-probe is placed within the tumour stenosis and electrical current is applied. New stents are inserted into all treated segments if needed.
Overall survival
Hazard ratio from a Cox regression model will be used to compare randomization arms. Covariates will be stratification variables, classification of local inoperability, use of prophylactic antibiotics, Bismuth type and time between diagnosis and beginning RFA/PDT.
Overall survival (complementary perspective: median survival time)
Estimates of the difference in median survival time between the groups will be based on the method of Chen and Zhang (PMID: 26983640).
Overall survival (complementary perspective: two-year overall survival)
Kaplan-Meier estimates will be used.
Overall survival (complementary perspective: restricted mean survival on a time horizon of two-years)
Kaplan-Meier estimates will be used (see e.g. PMID: 15690989)
Days alive and out of hospital up to two years
This constitutes a basic and easy to understand measure of quality of life. Only in-hospital stays will be included in this endpoint and the day of arrival and dismissal will each be counted. The source of data will be the hospital records, epicrisis and patient disclosure.
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University of Leipzig
Lead sponsor
Zentrum für Klinische Studien Leipzig
Collaborator
