Comparing two treatments for non-resectable bile duct cancer
Cholangiocarcinoma Treatment with Radiofrequency Ablation or Photodynamic Therapy: a Randomized Controlled Trial
This study is testing whether a light-based treatment or a heat-based treatment works better for people with a type of bile duct cancer that can't be surgically removed.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 258 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Leipzig Academic / other |
| Locations | 20 sites (Aachen and 19 other locations) |
| Trial ID | NCT05551299 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of photodynamic therapy (PDT) and radiofrequency ablation (RFA) in treating patients with non-resectable hilar cholangiocarcinoma, a type of bile duct cancer. Patients will receive either PDT, which involves a photosensitizer and light application to kill cancer cells, or RFA, which uses heat to destroy cancer cells. The study will assess survival rates, side effects, and quality of life for participants. This trial is significant as it seeks to provide insights into the more widely available RFA technology compared to the less accessible PDT.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with confirmed hilar cholangiocarcinoma who are not eligible for surgery.
Not a fit: Patients with tumors that are not accessible endoscopically or those with severe coagulopathy or other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide patients with a more effective treatment option for non-resectable bile duct cancer.
How similar studies have performed: While this approach has not been extensively studied in randomized trials, similar studies have shown promise in using RFA for other types of cancers.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Hilar cholangiocarcinoma (cytological or histological confirmation) 2. Surgery is not planned 3. Age ≥ 18 years 4. Written informed consent Exclusion Criteria: 1. Tumour not accessible endoscopically 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
Where this trial is running
Aachen and 19 other locations
- Uniklinik RWTH Aachen, Medizinische Klinik III — Aachen, Germany (Recruiting)
- Universitätsklinikum Augsburg; III. Med. Klinik — Augsburg, Germany (Recruiting)
- Vivantes Netzwerk für Gesundheit GmbH, Klinikum Friedrichshain, Innere Medizin/Gastroenterologie — Berlin, Germany (Not_yet_recruiting)
- Universitatsklinikum Bonn, Medizinische Klinik und Poliklinik I — Bonn, Germany (Recruiting)
- Universitätsklinikum Frankfurt, Medizinische Klinik 1 — Frankfurt, Germany (Not_yet_recruiting)
- Universitätsklinikum Freiburg, Medizinische Klinik II, Abteilung Gastroenterologie, Hepatologie, Endokrinologie & lnfektiologie — Freiburg im Breisgau, Germany (Recruiting)
- Universitätsmedizin Greifswald Klinik für Innere Medizin A — Greifswald, Germany (Recruiting)
- Site: Martin-Luther-Universitat Halle-Wittenberg, Universitätsklinik und Poliklinik für Innere Medizin I — Halle, Germany (Recruiting)
- Klinikum Hanau; Klinik für Gastroenterologie, Diabetologie und Infektiologie — Hanau, Germany (Recruiting)
- KRH Klinikum Siloah, Klinik für Gastroenterologie — Hanover, Germany (Recruiting)
- Klinikum St. Georg gGmbH; Klinik für Gastroenterologie, Hepatologie, Diabetologie und Endokrinologie — Leipzig, Germany (Recruiting)
- University Hospital of Leipzig, Department of Gastroenterology — Leipzig, Germany (Recruiting)
- RKH Kliniken Ludwigsburg- Bietigheim gGmbH, Klinik für Innere Medizin, Gastroenterologie, Hämato-Onkologie, Diabetologie und Infektiologie — Ludwigsburg, Germany (Recruiting)
- Universitätsmedizin Mannheim, II. Medizinische Klinik — Mannheim, Germany (Withdrawn)
- Universitätsklinikum Gießen und Marburg GmbH (UKGM); Klinik für Innere Medizin mit den Schwerpunkten Gastroenterologie, Endokrinologie, Stoffwechsel und klinische Infektiologie — Marburg, Germany (Recruiting)
- Klinikum der LMU München, Medizinische Klinik II, Campus Großhadern — München, Germany (Recruiting)
- Universitlitsklinikum Munster Medizinische Klinik B (Gastroenterologie, Hepatologie, Endokrinologie, Klinische lnfektiologie) — Münster, Germany (Recruiting)
- Klinikum Nürnberg Nord; Gastroenterologie/ Endokrinologie — Nuremberg, Germany (Recruiting)
- Robert-Bosch-Krankenhaus (RBK) Stuttgart; Gastroenterologie, Hepatologie und Endokrinologie — Stuttgart, Germany (Recruiting)
- Universitätsklinikum Tübingen, Medizinische Klinik I — Tübingen, Germany (Recruiting)
Study contacts
- Principal investigator: Albrecht Hoffmeister, Prof.Dr.med. — Universitätsklinikum Leipzig; Bereich Gastroenterologie
- Study coordinator: Albrecht Hoffmeister, Prof.Dr.med.
- Email: albrecht.hoffmeister@medizin.uni-leipzig.de
- Phone: +49-341-97-12240
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.