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

Launched by UNIVERSITY OF LEIPZIG · Sep 20, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at two different treatments for patients with a specific type of bile duct cancer called hilar cholangiocarcinoma. The study will compare two methods: photodynamic therapy (PDT), which uses light to kill cancer cells after a special medicine is injected, and radiofrequency ablation (RFA), which uses heat to destroy the cancer cells. The goal is to see which treatment helps patients live longer and to understand the side effects and quality of life for those receiving treatment.

To be eligible for this trial, participants must be at least 18 years old and have a confirmed diagnosis of hilar cholangiocarcinoma without plans for surgery. They should also be able to give written consent to participate. The trial is open to all genders and is currently recruiting participants. Those who join can expect to receive one of the two treatments and will be monitored for their health and well-being throughout the study. It's important to note that certain health conditions or recent treatments may exclude someone from participating, so a thorough assessment will be done before enrollment.

Gender

ALL

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