Uterine Fibroid Embolization- Long Term Follow up and Technical Perspectives
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- clinical effect
研究概览
简要总结
The purpose of this prospective non-randomised study is to examine whether two different microspheres (Bead-Block and Embosphere) are equally effective in the treatment of the uterine fibroid controlled with contrast-enhanced MR examination.
Quantitative MR imaging, including dominant fibroid T1, T2 and contrast enhancement characteristics before intervention and 3 months after interventions will be analysed as a potential predictor of volumetric response after embolization.
Another purpose is to determine long-term follow-up in all patient treated in a period from 2001-2011 in OUH analysed retrospectively.
详细描述
Group 1: 26 patient will be treated with Bead-block microspheres - 700-900 µm microspheres or combinations of one vial 2 ml of 500-700 µm microspheres, follow by 700-900 µm microspheres until blood flow stop ( " cut the tree" appearance).
Group 2: 26 patient will be treated with Embosphere; 500-900 µm until "near-stasis" flow stop in the uterine artery.
Clinical and Technical success will be examined, and radiological follow-up 3 and 12 months after embolization using MR contrast-enhanced examination in a Bead Block group and only 3 months control in Embosphere group to assess total fibroid burden infraction degree and eventually residual contracts fibroid enhancement.
Quantitative MRI dominant fibroid characteristic for and 3 months after an intervention to examine eventually potential of as a possible predictor of the volumetric response of the uterine fibroid.
Retrospective study compromised all patient treated between January 2001 until January 2011 with follow up to January 2014, and re-intervention as well as complications rate analysis.
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 52 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •symptomatic uterus fibroma
排除标准
- •pelvic infection (cystitis, oophoritis, salpingitis, abscess, urethritis)
- •gravidity
- •uterus malignancy
- •big subserosal fibroma with stalk diameter of <2 cm
- •menopausal women
- •don,t want to be included into the study
- •concomitant adenomyosis
结局指标
主要结局
clinical effect
时间窗: one year
Primary goal is to achieve release of symptoms after intervention and it would be compared between the two techniques
次要结局
- reinterventions rate(one year)
研究者
Stevo Duvnjak,MD
Medical Doctor, Radiologist
Odense University Hospital