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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат 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.
• Процедура 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.

Первичные конечные точки

• Overall survival [Срок оценки: through study completion, an average of 1 year]

Вторичные конечные точки (12)

• Overall survival (complementary perspective: median survival time) [Срок оценки: through study completion, an average of 1 year]
• Overall survival (complementary perspective: two-year overall survival) [Срок оценки: up to two years]
• Overall survival (complementary perspective: restricted mean survival on a time horizon of two-years) [Срок оценки: through study completion, an average of 1 year]
• Days alive and out of hospital up to two years [Срок оценки: up to two years]
• Quality of Life (QoL) measured using QLQ-C30 at various points in time after randomization (V2 (14 days), V3 (ca. 3 months), as a function of time after 6 months, adjusting for the baseline value) [Срок оценки: through study completion, an average of 1 year]
• Quality of Life (QoL) measured using FACT-Hep at various points in time after randomization (V2 (14 days), V3 (ca. 3 months), as a function of time after 6 months, adjusting for the baseline value) [Срок оценки: through study completion, an average of 1 year]
• Quality-adjusted life years (QALYs) [Срок оценки: through study completion, an average of 1 year]
• Stent patency based on clinician's assessment (e.g. cholangitis, cholestasis, ultrasound) [Срок оценки: through study completion, an average of 1 year]
• Laboratory parameter (leucocytes) [Срок оценки: through study completion, an average of 1 year]
• Laboratory parameter (haematocrit) [Срок оценки: through study completion, an average of 1 year]
• Laboratory parameter (haemoglobin) [Срок оценки: through study completion, an average of 1 year]
• Laboratory parameter (bilirubin) [Срок оценки: through study completion, an average of 1 year]

Критерии участия

Критерии включения

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

Критерии исключения

• Tumour not accessible endoscopically
• Known hypersensitivity to porphyrins or to any of the other ingredients of the photosensitizer chosen
• Leukopenia (< 2000/mm3)
• Thrombocytopenia (< 100,000 / mm³)
• Severe, uncorrected coagulopathy (at the discretion of the physician)
• 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
• 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)
• 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)
• Participation in other interventional trials
• Patients under legal supervision or guardianship
• Pregnant or nursing women

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Германия · 20 центров

• Uniklinik RWTH Aachen, Medizinische Klinik III — Aachen
• Universitätsklinikum Augsburg; III. Med. Klinik — Augsburg
• Vivantes Netzwerk für Gesundheit GmbH, Klinikum Friedrichshain, Innere Medizin/Gastroenter — Berlin
• Universitatsklinikum Bonn, Medizinische Klinik und Poliklinik I — Bonn
• Universitätsklinikum Frankfurt, Medizinische Klinik 1 — Frankfurt
• Universitätsklinikum Freiburg, Medizinische Klinik II, Abteilung Gastroenterologie, Hepato — Freiburg im Breisgau
• Universitätsmedizin Greifswald Klinik für Innere Medizin A — Greifswald
• Site: Martin-Luther-Universitat Halle-Wittenberg, Universitätsklinik und Poliklinik für In — Halle
• … и ещё 12 центров

Идентификаторы

NCT: NCT05551299 · CARP · 2022-500107-50-00 · 434336116

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗