Treatment of Non-resectable Bile Duct Cancer with Radiofrequency Ablation or Photodynamic Therapy
NCT ID: NCT05551299
Last Updated: 2025-03-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
258 participants
INTERVENTIONAL
2023-02-10
2028-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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)
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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Surgery is not planned
3. Age ≥ 18 years
4. Written informed consent
Exclusion Criteria
2. Known hypersensitivity to porphyrins or to any of the other ingredients of the photosensitizer 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-threatening mass 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 Cooperative Oncology 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 30 days
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 appropriate contraceptive measures (implanon, injections, oral contraceptives, intrauterine devices, partner with vasectomy) while participating in the trial (participants using a hormone-based method have to be informed of possible effects of the trial medication on contraception)
16. Participation in other interventional trials
17. Patients under legal supervision or guardianship
18. Pregnant or nursing women
18 Years
ALL
No
Sponsors
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Zentrum für Klinische Studien Leipzig
OTHER
University of Leipzig
OTHER
Responsible Party
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Albrecht Hoffmeister
Prof. Dr. med.
Principal Investigators
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Albrecht Hoffmeister, Prof.Dr.med.
Role: PRINCIPAL_INVESTIGATOR
Universitätsklinikum Leipzig; Bereich Gastroenterologie
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Jörg Trojan, Prof. Dr.
Role: primary
Armin Küllmer, Dr.
Role: primary
Other Identifiers
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2022-500107-50-00
Identifier Type: OTHER
Identifier Source: secondary_id
434336116
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
CARP
Identifier Type: -
Identifier Source: org_study_id
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