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

Last updated: March 24, 2025
Sponsor: University of Leipzig
Overall Status: Active - Recruiting

Phase

4

Condition

Liver Cancer

Abdominal Cancer

Biliary Tract Cancer

Treatment

Radiofrequency ablation (RFA)

Photosensitizer

Clinical Study ID

NCT05551299
CARP
434336116
2022-500107-50-00
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  1. Hilar cholangiocarcinoma (cytological or histological confirmation)

  2. Surgery is not planned

  3. Age ≥ 18 years

  4. Written informed consent

Exclusion

Exclusion Criteria:

  1. Tumour not accessible endoscopically

  2. Known hypersensitivity to porphyrins or to any of the other ingredients of thephotosensitizer 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-threateningmass 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 CooperativeOncology 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 30days

  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 appropriatecontraceptive measures (implanon, injections, oral contraceptives, intrauterinedevices, partner with vasectomy) while participating in the trial (participantsusing a hormone-based method have to be informed of possible effects of the trialmedication on contraception)

  16. Participation in other interventional trials

  17. Patients under legal supervision or guardianship

  18. Pregnant or nursing women

Study Design

Total Participants: 258
Treatment Group(s): 2
Primary Treatment: Radiofrequency ablation (RFA)
Phase: 4
Study Start date:
February 10, 2023
Estimated Completion Date:
April 30, 2028

Study 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 duct obstruction and the aim of therapy is thus to keep the ducts open. This is accomplished through endoscopic retrograde cholangiopancreatography (ERCP) by implanting stents. Stent therapy combined with photodynamic therapy (PDT) extends life expectancy. PDT requires an injection of photosensitizer that is absorbed primarily by the cancer cells. Light of a particular wavelength is then applied with ERCP 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 applied during ERCP. 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 Klatskin tumours depending on whether they receive PDT or RFA. Moreover, data will be collected on side-effects and quality of life.

Connect with a study center

  • Uniklinik RWTH Aachen, Medizinische Klinik III

    Aachen, 52074
    Germany

    Active - Recruiting

  • Universitätsklinikum Augsburg; III. Med. Klinik

    Augsburg, 86156
    Germany

    Active - Recruiting

  • Vivantes Netzwerk für Gesundheit GmbH, Klinikum Friedrichshain, Innere Medizin/Gastroenterologie

    Berlin, 10249
    Germany

    Site Not Available

  • Universitatsklinikum Bonn, Medizinische Klinik und Poliklinik I

    Bonn, 53127
    Germany

    Active - Recruiting

  • Universitätsklinikum Frankfurt, Medizinische Klinik 1

    Frankfurt, 60590
    Germany

    Site Not Available

  • Universitätsklinikum Freiburg, Medizinische Klinik II, Abteilung Gastroenterologie, Hepatologie, Endokrinologie & lnfektiologie

    Freiburg, 79106
    Germany

    Active - Recruiting

  • Universitätsmedizin Greifswald Klinik für Innere Medizin A

    Greifswald, 17475
    Germany

    Active - Recruiting

  • Site: Martin-Luther-Universitat Halle-Wittenberg, Universitätsklinik und Poliklinik für Innere Medizin I

    Halle, 06120
    Germany

    Active - Recruiting

  • Klinikum Hanau; Klinik für Gastroenterologie, Diabetologie und Infektiologie

    Hanau, 63450
    Germany

    Active - Recruiting

  • KRH Klinikum Siloah, Klinik für Gastroenterologie

    Hannover, 30459
    Germany

    Active - Recruiting

  • Klinikum St. Georg gGmbH; Klinik für Gastroenterologie, Hepatologie, Diabetologie und Endokrinologie

    Leipzig, 04109
    Germany

    Active - Recruiting

  • University Hospital of Leipzig, Department of Gastroenterology

    Leipzig,
    Germany

    Active - Recruiting

  • RKH Kliniken Ludwigsburg- Bietigheim gGmbH, Klinik für Innere Medizin, Gastroenterologie, Hämato-Onkologie, Diabetologie und Infektiologie

    Ludwigsburg, 71640
    Germany

    Active - Recruiting

  • Universitätsmedizin Mannheim, II. Medizinische Klinik

    Mannheim, 68167
    Germany

    Site Not Available

  • Universitätsklinikum Gießen und Marburg GmbH (UKGM); Klinik für Innere Medizin mit den Schwerpunkten Gastroenterologie, Endokrinologie, Stoffwechsel und klinische Infektiologie

    Marburg, 35043
    Germany

    Active - Recruiting

  • Klinikum der LMU München, Medizinische Klinik II, Campus Großhadern

    München, 81377
    Germany

    Active - Recruiting

  • Universitlitsklinikum Munster Medizinische Klinik B (Gastroenterologie, Hepatologie, Endokrinologie, Klinische lnfektiologie)

    Münster, 48149
    Germany

    Active - Recruiting

  • Klinikum Nürnberg Nord; Gastroenterologie/ Endokrinologie

    Nürnberg, 90419
    Germany

    Active - Recruiting

  • Robert-Bosch-Krankenhaus (RBK) Stuttgart; Gastroenterologie, Hepatologie und Endokrinologie

    Stuttgart, 70376
    Germany

    Active - Recruiting

  • Universitätsklinikum Tübingen, Medizinische Klinik I

    Tübingen, 72076
    Germany

    Active - Recruiting

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