NCT05551299RecruitingPhase 4
Treatment of Non-resectable Bile Duct Cancer with Radiofrequency Ablation or Photodynamic Therapy
Cholangiocarcinoma Treatment with Radiofrequency Ablation or Photodynamic Therapy: a Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 27 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 258 (estimated)
- First submitted
- 8 Sept 2022
- Start date
- 10 Feb 2023
- Primary completion date
- Apr 2028
- Lead sponsor
- University of Leipzig
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT05551299
- EU CT number
- 2022-500107-50-00
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 258
- From 10 Feb 2023 to the primary completion date, Apr 2028
- 23 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other illness
- 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
Other
- 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
Who the study is looking for
- Hilar cholangiocarcinoma (cytological or histological confirmation)
- Surgery is not planned
- Age ≥ 18 years
- Written informed consent
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (23)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitaetsklinikum Aachen AöR Coordinator of this site? Confirm its status | Aachen | Germany | Recruiting |
| Universitaetsklinikum Augsburg Coordinator of this site? Confirm its status | Augsburg | Germany | Recruiting |
| Vivantes Netzwerk fuer Gesundheit GmbH Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| Universitaetsklinikum Knappschaftskrankenhaus Bochum GmbH Coordinator of this site? Confirm its status | Bochum | Germany | Recruiting |
| Universitaetsklinikum Bonn AöR Coordinator of this site? Confirm its status | Bonn | Germany | Recruiting |
| Goethe University Frankfurt Coordinator of this site? Confirm its status | Frankfurt Am Main | Germany | Recruiting |
| Medical Center- University of Freiburg Coordinator of this site? Confirm its status | Freiburg im Breisgau | Germany | Recruiting |
| Universitaetsmedizin Goettingen Coordinator of this site? Confirm its status | Goettingen | Germany | Recruiting |
| Universitaetsmedizin Greifswald KöR Coordinator of this site? Confirm its status | Greifswald | Germany | Recruiting |
| Martin-Luther-Universitat Halle-Wittenberg Coordinator of this site? Confirm its status | Halle (saale) | Germany | Recruiting |
| Klinikum Hanau GmbH Coordinator of this site? Confirm its status | Hanau | Germany | Recruiting |
| Klinikum Region Hannover GmbH Coordinator of this site? Confirm its status | Hanover | Germany | Recruiting |
| Klinikum St. Georg gGmbH Coordinator of this site? Confirm its status | Leipzig | Germany | Recruiting |
| University of Leipzig Coordinator of this site? Confirm its status | Leipzig | Germany | Recruiting |
| RKH Klinken Ludwigsburg-Bietigheim gGmbH Coordinator of this site? Confirm its status | Ludwigsburg | Germany | Recruiting |
| Universitat Heidelberg Coordinator of this site? Confirm its status | Mannheim | Germany | Recruiting |
| Philipps-Universitaet Marburg Coordinator of this site? Confirm its status | Marburg | Germany | Recruiting |
| Westfaelische Wilhelms-Universitaet Muenster Coordinator of this site? Confirm its status | Muenster | Germany | Recruiting |
| Klinikum der Universitaet Muenchen AöR Coordinator of this site? Confirm its status | Munich | Germany | Recruiting |
| Klinikum Nuernberg Coordinator of this site? Confirm its status | Nuremberg | Germany | Recruiting |
| Klinikum Der Landeshauptstadt Stuttgart gKAöR Coordinator of this site? Confirm its status | Stuttgart | Germany | Recruiting |
| Robert Bosch Krankenhaus GmbH Coordinator of this site? Confirm its status | Stuttgart | Germany | Recruiting |
| Universitaetsklinikum Tuebingen AöR Coordinator of this site? Confirm its status | Tuebingen | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.