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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| embolizations, uterine fibroid | Other | embolization interventions with microspheres |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| embolizations ,uterine fibroid | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| clinical effect | Primary goal is to achieve release of symptoms after intervention and it would be compared between the two techniques | one year |
| Measure | Description | Time Frame |
|---|---|---|
| reinterventions rate | one year |
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Inclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Stevo Duvnjak, MD | Odense University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Odense University Hospital | Odense | Denmark | 5000 | Denmark | ||
| Odense University Hospital |
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| ID | Term |
|---|---|
| D007889 | Leiomyoma |
| ID | Term |
|---|---|
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D004621 | Embolization, Therapeutic |
| D008863 | Microspheres |
| ID | Term |
|---|---|
| D006489 | Hemostatic Techniques |
| D013812 | Therapeutics |
| D060205 | Therapeutic Occlusion |
| D004864 | Equipment and Supplies |
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| embolizations | Procedure | comparison between the two microspheres |
|
|
| Odense |
| Fyn |
| 5000 |
| Denmark |