跳至主要内容
临床试验/NCT06231628
NCT06231628尚未招募不适用

Immediate and Short-term Outcomes of Imaging Guided Percutaneous Cementoplasty for Pelvic Bone Metastases

Assiut University0 个研究点目标入组 20 人开始时间: 2024年2月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
20
主要终点
Pain reduction

研究概览

简要总结

This study aimed to summarize the immediate operative and short-term efficacy and safety outcomes of percutaneous cementoplasty for pelvic metastases

详细描述

Bone metastasis (BM) is the major cause of morbidity in patients with cancer. After lungs and liver, bone is the third most common site of metastatic disease. Prostate and breast cancers are responsible for the majority of bone metastases (up to 70%), followed by thyroid, lung, urinary bladder, and renal cancers, and finally melanoma. The incidence of bone metastasis is approximately 100,000 new cases per year in the united states and is increasing. Bone metastasis could result in skeletal-related events, including pain, pathological fracture, hypercalcemia, and nerve and visceral compression, which seriously affect the quality of life (QoL) of cancer patients. Bone metastases can be classified as osteolytic (osteoclast-mediated bone resorption), osteoblastic (osteoblast-mediated bone deposition), or mixed.

Fifty percent of the pain symptoms experienced by patients with cancer originate from BM. Tumor extension to neural structures, can cause a pain that may be radicular (exacerbated by percussion or palpation) and/or mechanical (exacerbated by movement). In advanced cases, pain can become intolerable and refractory to conventional therapies, resulting in walking disability, psychological and functional impact, and significant worsening of the QoL.

The effectiveness of surgery for bone metastasis in advanced cancer patients is limited to improvement of patients' quality of life. In most of these patients, complete resection or extended curettage of the bone metastasis with major reconstruction is often not feasible due to their poor general condition and accompanying other metastases. For some types of these bone metastases, surgical resection can lead to the stripping of the surrounding soft tissue and muscle attachment and addressing bone defects, causing more intraoperative bleeding, prolonged healing time, and increase the risk of wound complications, which in turn result in a longer recovery time for patients who usually have a limited life expectancy. Therefore, less invasive procedures, including percutaneous ablation (microwave ablation, radiofrequency ablation, cryoablation, and high-energy ultrasound) and/or bone cement [polymethylmethacrylate (PMMA)] injection, have become possible options. This is especially true for pelvic metastatic lesions because the surgery is particularly burdensome.

In addition, life expectancy of patients with metastatic bone disease is the most important factor in the decision making for surgical and/or medical treatment. A short life expectancy is in favor of the use of less invasive procedures, that have lower complication rates and shorter rehabilitation times. In these situations, interventional radiology procedures play an important either primary or complementary role in the management of bone metastases, especially in terms of palliation of pain, improvement of ambulation problems and treatment of fractures. This is because short life expectancies, more often, require palliative rather than curative regimens and make rapid pain relief to become a priority.

Aim of the study This study aimed to summarize the immediate operative and short-term efficacy and safety outcomes of percutaneous cementoplasty for pelvic metastases.

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

性别
All
接受健康志愿者

入选标准

  • refractory pain and/or gait disturbance caused by pelvic bone metastasis, did not respond to conservative treatment.
  • osteolytic lesion (in predominance) suitable for the pain.
  • limited life expectancy (less than 3 years) or stopping medical treatment

排除标准

  • There are no absolute contraindications for the procedure; however, the relative contraindications are:
  • patients in poor condition with an expected survival period of less than 3 months.
  • patients with stable course, with long life expectancy (more than 3 years) or those considered candidates for major pelvic surgery including tumor removal and hip arthroplasty.
  • presence of bone destruction with soft tissue mass contaminating important organs, nerves and blood vessels (improvement is not expected).
  • Patients refusing to give a written consent to the study protocol.

结局指标

主要结局

Pain reduction

时间窗: 3 months

To evaluate pain, the numerical pain score (NRS) will be used. The NRS is an 11-point numerical scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain (Figure 3) and pain is classified as mild pain if 1-4 points (tolerable), moderate if 5-6 points and severe if 7-10 points. NRS has been shown to be particularly reliable especially among patients with low health literacy. The NRS is also simple to score, and can be administered both orally and in written form.

次要结局

  • Gait status(3 months)
  • Number of participants with pathological fracture in the pelvic bones at the treated sites (by bone window CT)(3 months)
  • Number of participants with pulmonary embolism(3 months)
  • Number of participants with bone cement implantation syndrome (BCIS)(3 months)
  • Number of participants with mortality(3 months)
  • Gate function change(3 months)
  • Number of participants with extraosseous cement leakage(3 months)
  • Number of participants with pathological fracture of the pelvic bones(3 months)

研究者

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

Maha Hosam Hasan Ali

Resident Radiology

Assiut University

相似试验