Arterial Embolization, Uterine Fibroids
Conditions
Brief summary
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.
Detailed description
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.
Interventions
26 patients will be treat with Bead-block microspheres, 500-700 and 700-900µm until flow stop ( cut the tree appearance) 26 patients will be treat with Embosphere, 500-700µm and /or 700-900 until near stasis flow stop
comparison between the two microspheres
Sponsors
Study design
Eligibility
Inclusion criteria
* symptomatic uterus fibroma
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| clinical effect | one year | Primary goal is to achieve release of symptoms after intervention and it would be compared between the two techniques |
Secondary
| Measure | Time frame |
|---|---|
| reinterventions rate | one year |
Countries
Denmark