Status:
RECRUITING
Treatment of Non-resectable Bile Duct Cancer with Radiofrequency Ablation or Photodynamic Therapy
Lead Sponsor:
University of Leipzig
Collaborating Sponsors:
Zentrum für Klinische Studien Leipzig
Conditions:
Hilar Cholangiocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 expe...
Detailed Description
Klatskin tumours are a form of bile duct cancer. They are generally not diagnosed until quite late and a curative operation is rarely a possibility. Their anatomic location usually results in bile duc...
Eligibility Criteria
Inclusion Criteria:
- Hilar cholangiocarcinoma (cytological or histological confirmation)
- Surgery is not planned
- Age ≥ 18 years
- Written informed consent
Exclusion Criteria:
- Tumour not accessible endoscopically
- Known hypersensitivity to porphyrins or to any of the other ingredients of the photosensitizer chosen
- Leukopenia (< 2000/mm3)
- Thrombocytopenia (< 100,000 / mm³)
- Severe, uncorrected coagulopathy (at the discretion of the physician)
- 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
- 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)
- 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)
- Participation in other interventional trials
- Patients under legal supervision or guardianship
- Pregnant or nursing women
Key Trial Info
Start Date :
February 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2028
Estimated Enrollment :
258 Patients enrolled
Trial Details
Trial ID
NCT05551299
Start Date
February 10 2023
End Date
April 1 2028
Last Update
March 27 2025
Active Locations (20)
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1
Uniklinik RWTH Aachen, Medizinische Klinik III
Aachen, Germany, 52074
2
Universitätsklinikum Augsburg; III. Med. Klinik
Augsburg, Germany, 86156
3
Vivantes Netzwerk für Gesundheit GmbH, Klinikum Friedrichshain, Innere Medizin/Gastroenterologie
Berlin, Germany, 10249
4
Universitatsklinikum Bonn, Medizinische Klinik und Poliklinik I
Bonn, Germany, 53127