Uterine Fibroid Embolization- Long Term Follow up and Technical Perspectives

Odense University Hospital

Status: Completed

Conditions: Arterial Embolization; Uterine Fibroids

Treatments: Procedure: embolizations; Procedure: embolizations ,uterine fibroid

Study type: Interventional

Funder types: Other

Identifiers

NCT01852734

OUH-2013

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 patients

Sex: Female

Ages: 18 to 52 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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52 participants in 1 patient group

embolizations, uterine fibroid

Other group

Description:

embolization interventions with microspheres

Treatment:

Procedure: embolizations ,uterine fibroid

Procedure: embolizations