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Treatment of Non-resectable Bile Duct Cancer with Radiofrequency Ablation or Photodynamic Therapy
Sponsor: University of Leipzig
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.
Official title: Cholangiocarcinoma Treatment with Radiofrequency Ablation or Photodynamic Therapy: a Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
258
Start Date
2023-02-10
Completion Date
2028-04
Last Updated
2025-03-27
Healthy Volunteers
No
Conditions
Interventions
Photosensitizer
A photosensitizer, which is absorbed preferentially by tumour cells, is administered 24 - 48 hours prior to PDT. Light of a particular wavelength is then applied during endoscopic retrograde cholangiopancreatography (ERCP) to kill primarily cancer cells locally within the stenosis. Immediately after PDT treatment, new stents are inserted into all treated segments if needed.
Radiofrequency ablation (RFA)
RFA is also carried out as part of an ERCP. The RFA-probe is placed within the tumour stenosis and electrical current is applied. New stents are inserted into all treated segments if needed.
Locations (20)
Uniklinik RWTH Aachen, Medizinische Klinik III
Aachen, Germany
Universitätsklinikum Augsburg; III. Med. Klinik
Augsburg, Germany
Vivantes Netzwerk für Gesundheit GmbH, Klinikum Friedrichshain, Innere Medizin/Gastroenterologie
Berlin, Germany
Universitatsklinikum Bonn, Medizinische Klinik und Poliklinik I
Bonn, Germany
Universitätsklinikum Frankfurt, Medizinische Klinik 1
Frankfurt, Germany
Universitätsklinikum Freiburg, Medizinische Klinik II, Abteilung Gastroenterologie, Hepatologie, Endokrinologie & lnfektiologie
Freiburg im Breisgau, Germany
Universitätsmedizin Greifswald Klinik für Innere Medizin A
Greifswald, Germany
Site: Martin-Luther-Universitat Halle-Wittenberg, Universitätsklinik und Poliklinik für Innere Medizin I
Halle, Germany
Klinikum Hanau; Klinik für Gastroenterologie, Diabetologie und Infektiologie
Hanau, Germany
KRH Klinikum Siloah, Klinik für Gastroenterologie
Hanover, Germany
Klinikum St. Georg gGmbH; Klinik für Gastroenterologie, Hepatologie, Diabetologie und Endokrinologie
Leipzig, Germany
University Hospital of Leipzig, Department of Gastroenterology
Leipzig, Germany
RKH Kliniken Ludwigsburg- Bietigheim gGmbH, Klinik für Innere Medizin, Gastroenterologie, Hämato-Onkologie, Diabetologie und Infektiologie
Ludwigsburg, Germany
Universitätsmedizin Mannheim, II. Medizinische Klinik
Mannheim, Germany
Universitätsklinikum Gießen und Marburg GmbH (UKGM); Klinik für Innere Medizin mit den Schwerpunkten Gastroenterologie, Endokrinologie, Stoffwechsel und klinische Infektiologie
Marburg, Germany
Klinikum der LMU München, Medizinische Klinik II, Campus Großhadern
München, Germany
Universitlitsklinikum Munster Medizinische Klinik B (Gastroenterologie, Hepatologie, Endokrinologie, Klinische lnfektiologie)
Münster, Germany
Klinikum Nürnberg Nord; Gastroenterologie/ Endokrinologie
Nuremberg, Germany
Robert-Bosch-Krankenhaus (RBK) Stuttgart; Gastroenterologie, Hepatologie und Endokrinologie
Stuttgart, Germany
Universitätsklinikum Tübingen, Medizinische Klinik I
Tübingen, Germany