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

Phase 4RecruitingNCT05551299

University of Leipzig258 enrolled

Overview

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.

Klatskin tumours are a form of bile duct cancer. They are generally not diagnosed until quite late and a curative operation is rarely a possibility. Their anatomic location usually results in bile duct obstruction and the aim of therapy is thus to keep the ducts open. This is accomplished through endoscopic retrograde cholangiopancreatography (ERCP) by implanting stents. Stent therapy combined with photodynamic therapy (PDT) extends life expectancy. PDT requires an injection of photosensitizer that is absorbed primarily by the cancer cells. Light of a particular wavelength is then applied with ERCP 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 applied during ERCP. 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 Klatskin tumours depending on whether they receive PDT or RFA. Moreover, data will be collected on side-effects and quality of life.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Interventions

PhotosensitizerDRUG

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)PROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (20)

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

Outcomes

Primary Outcomes

Overall survival

Hazard ratio from a Cox regression model will be used to compare randomization arms. Covariates will be stratification variables, classification of local inoperability, use of prophylactic antibiotics, Bismuth type and time between diagnosis and beginning RFA/PDT.