Interventional Radiology Strategies in Management of Painful Bony Lesions
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- pain management
研究概览
简要总结
To explore the capability of the interventional radiology techniques in management of the painful bony lesions .
详细描述
Bone tumors may present as incidental findings, with pain or loss of function, or as fractures [1].
Interventional Radiology (IR) has experienced an exponential growth in recent years. Technological advances of the last decades have made it possible to use new treatments on a larger scale, with good results in terms of safety and effectiveness[2] .
Today, IR represents a minimally invasive option of treatment for benign bony lesions (osteoid osteoma [OO], osteoblastoma, periosteal chondroma, etc.) and for palliation of metastases involving bone and soft-tissue sites beyond the liver and lung in an always-increasing number of cases [3][4].
The aim of minimally-invasive ablation treatment is addressing the biological pain due to the stretching and irritation of the periosteum secondary to tumor growth and due to osteoclast-mediated bone resorption with the release of neurostimulating cytokines. The purpose of cementoplasty is to treat the mechanical pain for the instability from pathologic microfractures [5] Radiofrequency ablation (RFA) and cementoplasty are safe, feasible, and promising clinical option for the management of painful bony tumors that are challenging for their morphology and location [6].
Also , there is a broad range of indications for transarterial embolization (TAE) in primary or metastatic bone tumors: to reduce operative haemorrhagic risks, to simplify or allow more definitive surgery, or in the context of pain palliation, fever, bleeding, or hypercalcemic and other rheological factors[1].
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Painful primary bone tumors .
- •Bone secondaries not amenable to radiation therapy .
- •histopathologically radioresistant bony tumors.
- •Painful osteoporotic vertebral fractures.
排除标准
- •1- Contraindications to contrast media 2- Raised renal chemistry or chronic kidney disease . 3- Pregnant patients . 4- Abnormal coagulation profile . 5- Contraindications to anesthesia .
结局指标
主要结局
pain management
时间窗: visual analogue score will be evaluated before the procedure and at 1-week and 3-, 6-, and 12-month follow-up outpatient office visits
quantification of the pain before and after treatment through VAS ( visual analogue scale ) score . it is a score from (0) to (10) . The minimum value (0) means no pain and highest value (10) means worst pain possible . Higher scores mean worse outcome .
次要结局
- The Functional Mobility Scale (FMS)(preoperatively and 1 month after the treatment to assess the effect of treatment on level of mobility and ability to walk)
- Local tumor control(performed 6 months after the treatment)
研究者
Kero Wagdy
principle investigator
Assiut University
