Embolizzazione Arteriosa Per il Trattamento Delle Metastasi Ossee: Studio Osservazionale Prospettico
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Improvement in quality of life (EORTC QLQ - BM22)
研究概览
简要总结
To date, arterial embolization constitutes one of the most popular methods in minimally invasive treatment of bone metastases, allowing good results in terms of pain reduction, local control of disease and reduction of peri-operative bleeding, with low invasiveness.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 of either sex of age or older who are candidates for embolization therapy
- •Life expectancy > 3 months
- •Single metastatic or oligometastatic.
- •Plurimetastatic if a particular site is causing painful symptoms or at risk for pathologic rupture
排除标准
- •Patients with life expectancy <3 months or severe functional status impairment (ASA 4)
- •Patients with hypovascular metastasis documented by angiography or MRI perfusion study with MDC.
- •Patients with coagulation deficiency or plateletopenic patients.
- •Patients with documented active infection.
结局指标
主要结局
Improvement in quality of life (EORTC QLQ - BM22)
时间窗: 1 year
Clinical assessment regarding quality of life by EORTC QLQ - BM22 questionnaire. The questionnaire consists of several scales, covering different aspects related to palliation. The maximum and minimum scores for each scale of the questionnaire can range from 0 to 100. The interpretation of scores depends on the specific scale in the questionnaire, and a higher value may indicate either greater negative impact (e.g., more symptoms or more suffering) or greater positive impact (e.g., better quality of life or less symptomatology). The overall assessment requires a detailed analysis of individual scores and related scales.
Reduction of pain (VAS score)
时间窗: 1 year
Clinical assessment regarding pain by Visual Analogue Scale (VAS) score (0-100 mm), in which 0 represents no pain, and 100 represents maximum pain imaginable.
Improvement in quality of life (EORTC QLQ-C15-PAL questionnaire)
时间窗: 1 year
Clinical assessment regarding quality of life by EORTC QLQ-C15-PAL questionnaire. The questionnaire consists of several scales, covering different aspects related to palliation. The maximum and minimum scores for each scale of the questionnaire can range from 0 to 100. The interpretation of scores depends on the specific scale in the questionnaire, and a higher value may indicate either greater negative impact (e.g., more symptoms or more suffering) or greater positive impact (e.g., better quality of life or less symptomatology). The overall assessment requires a detailed analysis of individual scores and related scales.
次要结局
- Volume reduction in cm(1 year)