Cholangiocarcinoma Treatment with Radiofrequency Ablation or Photodynamic Therapy: a Randomized Controlled Trial

Status: Recruiting
Location: See all (20) locations...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Hilar cholangiocarcinoma (cytological or histological confirmation)

• Surgery is not planned

• Age ≥ 18 years

• Written informed consent

Locations
Other Locations
Germany
Uniklinik RWTH Aachen, Medizinische Klinik III
RECRUITING
Aachen
Universitätsklinikum Augsburg; III. Med. Klinik
RECRUITING
Augsburg
Vivantes Netzwerk für Gesundheit GmbH, Klinikum Friedrichshain, Innere Medizin/Gastroenterologie
NOT_YET_RECRUITING
Berlin
Universitatsklinikum Bonn, Medizinische Klinik und Poliklinik I
RECRUITING
Bonn
Universitätsklinikum Frankfurt, Medizinische Klinik 1
NOT_YET_RECRUITING
Frankfurt
Universitätsklinikum Freiburg, Medizinische Klinik II, Abteilung Gastroenterologie, Hepatologie, Endokrinologie & lnfektiologie
RECRUITING
Freiburg Im Breisgau
Universitätsmedizin Greifswald Klinik für Innere Medizin A
RECRUITING
Greifswald
Site: Martin-Luther-Universitat Halle-Wittenberg, Universitätsklinik und Poliklinik für Innere Medizin I
RECRUITING
Halle
Klinikum Hanau; Klinik für Gastroenterologie, Diabetologie und Infektiologie
RECRUITING
Hanau
KRH Klinikum Siloah, Klinik für Gastroenterologie
RECRUITING
Hanover
Klinikum St. Georg gGmbH; Klinik für Gastroenterologie, Hepatologie, Diabetologie und Endokrinologie
RECRUITING
Leipzig
University Hospital of Leipzig, Department of Gastroenterology
RECRUITING
Leipzig
RKH Kliniken Ludwigsburg- Bietigheim gGmbH, Klinik für Innere Medizin, Gastroenterologie, Hämato-Onkologie, Diabetologie und Infektiologie
RECRUITING
Ludwigsburg
Universitätsmedizin Mannheim, II. Medizinische Klinik
WITHDRAWN
Mannheim
Universitätsklinikum Gießen und Marburg GmbH (UKGM); Klinik für Innere Medizin mit den Schwerpunkten Gastroenterologie, Endokrinologie, Stoffwechsel und klinische Infektiologie
RECRUITING
Marburg
Klinikum der LMU München, Medizinische Klinik II, Campus Großhadern
RECRUITING
München
Universitlitsklinikum Munster Medizinische Klinik B (Gastroenterologie, Hepatologie, Endokrinologie, Klinische lnfektiologie)
RECRUITING
Münster
Klinikum Nürnberg Nord; Gastroenterologie/ Endokrinologie
RECRUITING
Nuremberg
Robert-Bosch-Krankenhaus (RBK) Stuttgart; Gastroenterologie, Hepatologie und Endokrinologie
RECRUITING
Stuttgart
Universitätsklinikum Tübingen, Medizinische Klinik I
RECRUITING
Tübingen
Contact Information
Primary
Albrecht Hoffmeister, Prof.Dr.med.
albrecht.hoffmeister@medizin.uni-leipzig.de
+49-341-97-12240
Backup
Marcus Hollenbach, Dr. med.
marcus.hollenbach@medizin.uni-leipzig.de
+49-341-97-12362
Time Frame
Start Date: 2023-02-10
Estimated Completion Date: 2028-04
Participants
Target number of participants: 258
Treatments
Experimental: Photodynamic therapy (PDT)
The index procedure in all patients at baseline includes stenting, using an endoscopic retrograde cholangio-pancreatography (ERCP) procedure. The Intervention is at least one PDT at baseline according to the clinical routine of the trial site.
Experimental: Radiofrequency ablation (RFA)
The index procedure in all patients at baseline includes stenting, using an endoscopic retrograde cholangio-pancreatography (ERCP) procedure. The Intervention is at least one RFA at baseline according to the clinical routine of the trial site.
Sponsors
Collaborators: Zentrum für Klinische Studien Leipzig
Leads: University of Leipzig

This content was sourced from clinicaltrials.gov