Percutaneous Ablation and Cementoplasty for Painful Bone Lesions: A Canadian Single-Centre Experience
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- Analgesia
研究概览
简要总结
The aim of this research study is to assess the effectiveness of combined ablation and cementoplasty in the treatment of spinal, pelvic, and extraspinal lesions causing pain resistant to conventional treatment at our centre. In particular, the investigator seek to verify the safety and efficacy for multiple primary tumor types and benign lesions as well as encompass multiple measurements of outcome, including visual analog scale (VAS) for pain, opioid and analgesic use, and overall performance scales, combined with cross-sectional imaging follow-up to assess tumor burden, to ascertain a comprehensive Canadian single-centre experience that has been lacking in previous studies.
详细描述
Research Question & Objectives
- To conduct a prospective, single-centre study of combined ablation and cementoplasty treatment for painful spinal and extraspinal osseous lesions.
- Report the technical outcome and safety of percutaneous ablation prior to image-guided cementoplasty in a single treatment session.
- Review the effectiveness and durability of pain control, local tumor control, and the impact on QoL using ablation and cementoplasty in treating spinal/extraspinal osseous tumors.
- Assess the feasibility and efficacy of ablation and cementoplasty treatment for different primary tumor types and benign lesions.
Research Design
The investigators will conduct a single-centre, single-arm, cohort analysis of all patients who undergo cementoplasty for osseous disease in the department of interventional radiology over a two-year period. This will be a prospective paired comparison study with patients serving as their own controls. Technical success and procedural complications will be monitored and recorded for all patients. All patients will be followed until death or 3 months post-procedure.
The investigators aim to enroll a minimum of 40 patients referred for symptomatic osseous lesions. Bipolar radiofrequency ablation (Osteocool RFA system, Medtronic) or cryoablation (Visual Ice Cryoablation, Boston Scientific) will be performed under CT, ultrasound, or fluoroscopic guidance at the discretion of the treating radiologist, and immediately followed by cement injection. Radiological outcomes, including local tumor control and disease progression, will be assessed by CT imaging immediately post-procedure as well as 3-month follow-up. Clinical outcomes will be evaluated by VAS, analgesic use, and QoL assessment using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) prior to procedure and immediately post-procedure, as well at 1-week, 1-month, and 3-month intervals post-procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •adult patient with spinal, pelvic, or extraspinal bone lesion
- •pain clinically localized to a single region and tumor involvement confirmed with imaging
- •life expectancy greater than 3 months
- •provision of informed consent
排除标准
- •non-correctable coagulation disorder
- •systemic or localized infection
- •multiple painful lesions requiring different treatment approaches
- •neurological deficits or radicular neurological symptoms
- •rheumatic disease
- •pregnancy
- •previous ablation and/or cementoplasty treatment to same lesion
结局指标
主要结局
Analgesia
时间窗: 3 months post-procedure
Opioid and non-opioid analgesia use
Pain Scale
时间窗: 3 months post-procedure
Visual Analog Scale; values 0-10 with 0 being no pain and 10 being the worst pain imaginable.
Quality of Life Questionnaire
时间窗: 3 months post-procedure
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). The QLQ-C30 is composed of 3 multi-item scales including a functional scale, a global health status/quality of life scale, and a symptom scale. Each scale ranges in score from 0-100 with a higher scale score representing a high/healthy level of functioning, quality of life, and symptomatology/problems, respectively.
次要结局
- Disease Burden(3 months post-procedure)
研究者
Jason Wong
Interventional Radiologist; Clinical Associate Professor, University of Calgary
University of Calgary