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:

  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

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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Page 1 of 5 (20 locations)

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