Uterine Fibroid Embolization- Long Term Follow up and Technical Perspectives

Not Applicable

Completed

• Conditions: Uterine Fibroids; Arterial Embolization

• Registration Number: NCT01852734
• Lead Sponsor: Odense University Hospital

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.

Study Timeline

• Study First Submitted: 2013-05-06
• Study First Submitted QC: 2013-05-13
• Study First Posted: 2013-05-14
• Study Start: 2013-11
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-23
• Last Update Posted: 2016-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
clinical effect	one year	Primary goal is to achieve release of symptoms after intervention and it would be compared between the two techniques

Secondary Outcome Measures

Name	Time	Method
reinterventions rate	one year

Trial Locations

Locations (1)

Odense University Hospital; 🇩🇰 Odense, Denmark