Actively Recruiting
Treatment of Non-resectable Bile Duct Cancer with Radiofrequency Ablation or Photodynamic Therapy
Led by University of Leipzig · Updated on 2025-03-27
258
Participants Needed
20
Research Sites
268 weeks
Total Duration
On this page
Sponsors
U
University of Leipzig
Lead Sponsor
Z
Zentrum für Klinische Studien Leipzig
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Treatment of Non-resectable Bile Duct Cancer with Radiofrequency Ablation or Photodynamic Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Hilar cholangiocarcinoma confirmed by cytology or histology
- No planned surgery for the cancer
- Age 18 years or older
- Able to give written informed consent
You will not qualify if you...
- Tumor not accessible by endoscopic procedure
- Known allergy to porphyrins or photosensitizer ingredients
- Low white blood cell count (less than 2000/mm3)
- Low platelet count (less than 100,000/mm3)
- Severe bleeding disorders not corrected
- Suspected major blood vessel erosion with bleeding risk
- Porphyria or other diseases worsened by light
- Severely impaired liver or kidney function
- Bedridden more than 50% of the time
- Planned surgery within 30 days
- Eye disease requiring slit lamp exam within 30 days
- Radiotherapy within the last four weeks
- Previous photodynamic therapy or radiofrequency ablation
- Planned liver transplant
- Women of childbearing potential without effective contraception
- Participation in other interventional trials
- Under legal supervision or guardianship
- Pregnant or nursing women
AI-Screening
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Trial Site Locations
Total: 20 locations
1
Uniklinik RWTH Aachen, Medizinische Klinik III
Aachen, Germany, 52074
Actively Recruiting
2
Universitätsklinikum Augsburg; III. Med. Klinik
Augsburg, Germany, 86156
Actively Recruiting
3
Vivantes Netzwerk für Gesundheit GmbH, Klinikum Friedrichshain, Innere Medizin/Gastroenterologie
Berlin, Germany, 10249
Not Yet Recruiting
4
Universitatsklinikum Bonn, Medizinische Klinik und Poliklinik I
Bonn, Germany, 53127
Actively Recruiting
5
Universitätsklinikum Frankfurt, Medizinische Klinik 1
Frankfurt, Germany, 60590
Not Yet Recruiting
6
Universitätsklinikum Freiburg, Medizinische Klinik II, Abteilung Gastroenterologie, Hepatologie, Endokrinologie & lnfektiologie
Freiburg im Breisgau, Germany, 79106
Actively Recruiting
7
Universitätsmedizin Greifswald Klinik für Innere Medizin A
Greifswald, Germany, 17475
Actively Recruiting
8
Site: Martin-Luther-Universitat Halle-Wittenberg, Universitätsklinik und Poliklinik für Innere Medizin I
Halle, Germany, 06120
Actively Recruiting
9
Klinikum Hanau; Klinik für Gastroenterologie, Diabetologie und Infektiologie
Hanau, Germany, 63450
Actively Recruiting
10
KRH Klinikum Siloah, Klinik für Gastroenterologie
Hanover, Germany, 30459
Actively Recruiting
11
Klinikum St. Georg gGmbH; Klinik für Gastroenterologie, Hepatologie, Diabetologie und Endokrinologie
Leipzig, Germany, 04109
Actively Recruiting
12
University Hospital of Leipzig, Department of Gastroenterology
Leipzig, Germany
Actively Recruiting
13
RKH Kliniken Ludwigsburg- Bietigheim gGmbH, Klinik für Innere Medizin, Gastroenterologie, Hämato-Onkologie, Diabetologie und Infektiologie
Ludwigsburg, Germany, 71640
Actively Recruiting
14
Universitätsmedizin Mannheim, II. Medizinische Klinik
Mannheim, Germany, 68167
Withdrawn
15
Universitätsklinikum Gießen und Marburg GmbH (UKGM); Klinik für Innere Medizin mit den Schwerpunkten Gastroenterologie, Endokrinologie, Stoffwechsel und klinische Infektiologie
Marburg, Germany, 35043
Actively Recruiting
16
Klinikum der LMU München, Medizinische Klinik II, Campus Großhadern
München, Germany, 81377
Actively Recruiting
17
Universitlitsklinikum Munster Medizinische Klinik B (Gastroenterologie, Hepatologie, Endokrinologie, Klinische lnfektiologie)
Münster, Germany, 48149
Actively Recruiting
18
Klinikum Nürnberg Nord; Gastroenterologie/ Endokrinologie
Nuremberg, Germany, 90419
Actively Recruiting
19
Robert-Bosch-Krankenhaus (RBK) Stuttgart; Gastroenterologie, Hepatologie und Endokrinologie
Stuttgart, Germany, 70376
Actively Recruiting
20
Universitätsklinikum Tübingen, Medizinische Klinik I
Tübingen, Germany, 72076
Actively Recruiting
Research Team
A
Albrecht Hoffmeister, Prof.Dr.med.
CONTACT
M
Marcus Hollenbach, Dr. med.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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