NCT05551299 Treatment of Non-resectable Bile Duct Cancer with Radiofrequency Ablation or Photodynamic Therapy
| NCT ID | NCT05551299 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Leipzig |
| Condition | Hilar Cholangiocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 258 participants |
| Start Date | 2023-02-10 |
| Primary Completion | 2028-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 258 participants in total. It began in 2023-02-10 with a primary completion date of 2028-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Hilar cholangiocarcinoma (cytological or histological confirmation) 2. Surgery is not planned 3. Age ≥ 18 years 4. Written informed consent Exclusion Criteria: 1. Tumour not accessible endoscopically 2. Known hypersensitivity to porphyrins or to any of the other ingredients of the photosensitizer chosen 3. Leukopenia (\< 2000/mm3) 4. Thrombocytopenia (\< 100,000 / mm³) 5. Severe, uncorrected coagulopathy (at the discretion of the physician) 6. Suspected erosion of major blood vessels, because of the risk of life-threatening mass haemorrhage exists 7. Porphyria (clinician's assessment) or other light-exacerbated diseases 8. Severely impaired liver and or kidney function (at the discretion of the physician) 9. Bedridden for more than 50% of the time (similar to ECOG (Eastern Cooperative Oncology Group) grade 3) 10. Planned surgical procedure within the next 30 days 11. Concurrent eye disease that will require a slit lamp examination within the next 30 days 12. Prior radiotherapy within the last four weeks 13. Previous PDT or RFA 14. Planned liver transplantation 15. 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) 16. Participation in other interventional trials 17. Patients under legal supervision or guardianship 18. Pregnant or nursing women
Contact & Investigator
Albrecht Hoffmeister, Prof.Dr.med.
PRINCIPAL INVESTIGATOR
Universitätsklinikum Leipzig; Bereich Gastroenterologie
Frequently Asked Questions
Who can join the NCT05551299 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hilar Cholangiocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05551299 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05551299 currently recruiting?
Yes, NCT05551299 is actively recruiting participants. Contact the research team at albrecht.hoffmeister@medizin.uni-leipzig.de for enrollment information.
Where is the NCT05551299 trial being conducted?
This trial is being conducted at Aachen, Germany, Augsburg, Germany, Berlin, Germany, Bonn, Germany and 11 additional locations.
Who is sponsoring the NCT05551299 clinical trial?
NCT05551299 is sponsored by University of Leipzig. The principal investigator is Albrecht Hoffmeister, Prof.Dr.med. at Universitätsklinikum Leipzig; Bereich Gastroenterologie. The trial plans to enroll 258 participants.