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NCT05551299RecruitingPhase 4

Treatment of Non-resectable Bile Duct Cancer with Radiofrequency Ablation or Photodynamic Therapy

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

Source: ClinicalTrials.gov · Last updated 27 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
258 (estimated)
First submitted
8 Sept 2022
Start date
10 Feb 2023
Primary completion date
Apr 2028
Lead sponsor
University of Leipzig
NCT number
NCT05551299
EU CT number
2022-500107-50-00

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 258
  • From 10 Feb 2023 to the primary completion date, Apr 2028
  • 23 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Planned surgical procedure within the next 30 days
  • Concurrent eye disease that will require a slit lamp examination within the next 30 days
  • Prior radiotherapy within the last four weeks
  • Previous PDT or RFA
  • Planned liver transplantation
  • 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)

Other illness

  • Known hypersensitivity to porphyrins or to any of the other ingredients of the photosensitizer chosen
  • Suspected erosion of major blood vessels, because of the risk of life-threatening mass haemorrhage exists
  • Porphyria (clinician's assessment) or other light-exacerbated diseases

Other

  • Tumour not accessible endoscopically
  • Leukopenia (\< 2000/mm3)
  • Thrombocytopenia (\< 100,000 / mm³)
  • Severe, uncorrected coagulopathy (at the discretion of the physician)
  • Severely impaired liver and or kidney function (at the discretion of the physician)
  • Bedridden for more than 50% of the time (similar to ECOG (Eastern Cooperative Oncology Group) grade 3)
  • Participation in other interventional trials
  • Patients under legal supervision or guardianship
  • Pregnant or nursing women

Who the study is looking for

  • Hilar cholangiocarcinoma (cytological or histological confirmation)
  • Surgery is not planned
  • Age ≥ 18 years
  • Written informed consent

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (23)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Universitaetsklinikum Aachen AöR
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AachenGermanyRecruiting
Universitaetsklinikum Augsburg
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AugsburgGermanyRecruiting
Vivantes Netzwerk fuer Gesundheit GmbH
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BerlinGermanyRecruiting
Universitaetsklinikum Knappschaftskrankenhaus Bochum GmbH
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BochumGermanyRecruiting
Universitaetsklinikum Bonn AöR
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BonnGermanyRecruiting
Goethe University Frankfurt
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Frankfurt Am MainGermanyRecruiting
Medical Center- University of Freiburg
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Freiburg im BreisgauGermanyRecruiting
Universitaetsmedizin Goettingen
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GoettingenGermanyRecruiting
Universitaetsmedizin Greifswald KöR
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GreifswaldGermanyRecruiting
Martin-Luther-Universitat Halle-Wittenberg
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Halle (saale)GermanyRecruiting
Klinikum Hanau GmbH
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HanauGermanyRecruiting
Klinikum Region Hannover GmbH
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HanoverGermanyRecruiting
Klinikum St. Georg gGmbH
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LeipzigGermanyRecruiting
University of Leipzig
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LeipzigGermanyRecruiting
RKH Klinken Ludwigsburg-Bietigheim gGmbH
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LudwigsburgGermanyRecruiting
Universitat Heidelberg
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MannheimGermanyRecruiting
Philipps-Universitaet Marburg
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MarburgGermanyRecruiting
Westfaelische Wilhelms-Universitaet Muenster
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MuensterGermanyRecruiting
Klinikum der Universitaet Muenchen AöR
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MunichGermanyRecruiting
Klinikum Nuernberg
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NurembergGermanyRecruiting
Klinikum Der Landeshauptstadt Stuttgart gKAöR
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StuttgartGermanyRecruiting
Robert Bosch Krankenhaus GmbH
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StuttgartGermanyRecruiting
Universitaetsklinikum Tuebingen AöR
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TuebingenGermanyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.