Spots Global Cancer Trial Database for Treatment of Non-resectable Bile Duct Cancer With Radiofrequency Ablation or Photodynamic Therapy
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Trial Identification
Brief Title: Treatment of Non-resectable Bile Duct Cancer With Radiofrequency Ablation or Photodynamic Therapy
Official Title: Cholangiocarcinoma Treatment With Radiofrequency Ablation or Photodynamic Therapy: a Randomized Controlled Trial
Study ID: NCT05551299
Conditions
Study Description
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 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.
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 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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, , 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, Hannover, , 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, Nürnberg, , Germany
Robert-Bosch-Krankenhaus (RBK) Stuttgart; Gastroenterologie, Hepatologie und Endokrinologie, Stuttgart, , Germany
Universitätsklinikum Tübingen, Medizinische Klinik I, Tübingen, , Germany
Contact Details
Name: Albrecht Hoffmeister, Prof.Dr.med.
Affiliation: Universitätsklinikum Leipzig; Bereich Gastroenterologie
Role: PRINCIPAL_INVESTIGATOR
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