Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hilar Cholangiocarcinoma | Hilar Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Photosensitizer | Drug | — | UNRESOLVED |
| Radiofrequency ablation (RFA) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Photodynamic therapy (PDT)
- description
- The index procedure in all patients at baseline includes stenting, using an endoscopic retrograde cholangio-pancreatography (ERCP) procedure. The Intervention is at least one PDT at baseline according to the clinical routine of the trial site.
- interventionNames
- Drug: Photosensitizer
- type
- EXPERIMENTAL
- label
- Radiofrequency ablation (RFA)
- description
- The index procedure in all patients at baseline includes stenting, using an endoscopic retrograde cholangio-pancreatography (ERCP) procedure. The Intervention is at least one RFA at baseline according to the clinical routine of the trial site.
- interventionNames
- Procedure: Radiofrequency ablation (RFA)
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available