Cholangiocarcinoma Treatment with Radiofrequency Ablation or Photodynamic Therapy: a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 258
- 试验地点
- 20
- 主要终点
- Overall survival
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hilar cholangiocarcinoma (cytological or histological confirmation)
- •Surgery is not planned
- •Age ≥ 18 years
- •Written informed consent
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Photosensitizer (Drug)
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.
干预措施: Radiofrequency ablation (RFA) (Procedure)
结局指标
主要结局
Overall survival
时间窗: through study completion, an average of 1 year
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.
次要结局
- Overall survival (complementary perspective: restricted mean survival on a time horizon of two-years)(through study completion, an average of 1 year)
- Stent patency based on clinician's assessment (e.g. cholangitis, cholestasis, ultrasound)(through study completion, an average of 1 year)
- Quality-adjusted life years (QALYs)(through study completion, an average of 1 year)
- Overall survival (complementary perspective: median survival time)(through study completion, an average of 1 year)
- Overall survival (complementary perspective: two-year overall survival)(up to two years)
- Days alive and out of hospital up to two years(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)(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)(through study completion, an average of 1 year)
- Laboratory parameter (haematocrit)(through study completion, an average of 1 year)
- Laboratory parameter (haemoglobin)(through study completion, an average of 1 year)
- Laboratory parameter (bilirubin)(through study completion, an average of 1 year)
- Laboratory parameter (albumin)(through study completion, an average of 1 year)
- Laboratory parameter (ALT)(through study completion, an average of 1 year)
- Laboratory parameter (leucocytes)(through study completion, an average of 1 year)
- Laboratory parameter (CA 19-9)(through study completion, an average of 1 year)
- Laboratory parameter (CRP)(through study completion, an average of 1 year)
- Pruritus as reported by patients on a scale from 0 ("no itching") to 10 ("worst imaginable itching").(through study completion, an average of 1 year)
- Laboratory parameter (GGT)(through study completion, an average of 1 year)
研究者
Albrecht Hoffmeister
Prof. Dr. med.
University of Leipzig