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临床试验/NCT05738941
NCT05738941尚未招募不适用

Interventional Radiology Strategies in Management of Painful Bony Lesions

Assiut University0 个研究点目标入组 50 人开始时间: 2025年3月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kero Wagdy

principle investigator

Assiut University

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