Invasive Treatment of Pain Associated With Pancreatic Cancer on Different Levels of WHO Analgesic Ladder
试验速览
- 阶段
- 不适用
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change from baseline pain intensity at 1 year (BPI questionnaires)
研究概览
简要总结
Pancreatic cancer is a difficult to treat disease, mainly due to the fact that diagnosis is made usually in the late stage of this condition. One of the treatment methods of pain accompanying this neoplasm is thoracoscopic splanchnicectomy. It has been shown that it is a safe procedure with a small percentage of complications, nevertheless it is often use as the last stage in pain management what significantly decreases its effectiveness.
The aim of this study is to determinate the effect of invasive pain treatment (splanchnicectomy) in patients with advanced pancreatic cancer on subjective pain perception at rest, in movement and after meals (measured with the BPI, QLQ- C30 and FACIT questionnaires), and suffering (measured with PRISM projection test), the use of painkillers during the disease and patients' overall survival. Moreover the investigators want to check if early performance of splanchnicectomy (on lower steps of analgesic ladder WHO) is combined with better therapeutic effect of this treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Patients diagnosed with pancreatic cancer
- •Age over 18 years
- •Signed informed consent to participate in the study
排除标准
- •Age under 18 years
- •Intellectual inability to fill the questionnaires
- •Co-occurrence of a disease in which significant chronic pain exists, which was recognized before the onset of pancreatic cancer
结局指标
主要结局
Change from baseline pain intensity at 1 year (BPI questionnaires)
时间窗: one year
次要结局
- Quality of life and pain intensity measurement (measured with the QLQ- C30, FACIT and BPI questionnaires)(From date of randomization until the date of death from any cause,assessed up to 100 months)
研究者
Łukasz Dobosz
MD
Medical University of Gdansk