Clinical Trial

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

Study acronym: CARP
Recruiting Phase 4
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Summary
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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2022-09-20; most recent amendment 2025-03-24.
Status change: Not Yet Recruiting → Recruiting 2022-10-14
Trial Details
NCT Number NCT05551299
Lead Sponsor University of Leipzig
Collaborators: Zentrum für Klinische Studien Leipzig
Conditions Hilar Cholangiocarcinoma
Enrollment 258 participants
Start Date 2023-02-10
Primary Completion 2028-04 (estimated)
Study Completion 2028-04 (estimated)
Updated on ClinicalTrials.gov 2025-03-27