Consultant
Stevo Duvnjak
Department of Radiology, Odense University Hospital
| Project management | ||
| Project status | Closed | |
| Data collection dates | ||
| Start | 01.02.2013 | |
| End | 01.09.2016 | |
Uterine Fibroid Embolization- Long Term Follow up and Technical Perspectives
Short summary
The purpose of this study is to determine whether two different microspheres (Bead-Block and Embosphere) are equally effective or is that any difference between the two microspheres in the treatment of the uterine fibroid controlled with contrast-enhanced MR examination.
Rationale
The purpose of this study is to determine whether two different microspheres (Bead-Block and Embosphere) are equally effective or is that any difference between the two microspheres in the treatment of the uterine fibroid controlled with contrast-enhanced MR examination.
Diffusion-weighted MR imaging before intervention and 3 and 12 months after interventions will be analyzed 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 analyzed retrospectively.
Description of the cohort
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.
Data and biological material
Clinical and technical success would be assessed. Clinical and radiological follow up after 3 and 12 months.
Contrast enhanced MRI (magnetic resonance imaging) of the pelvis, 3 and 12 month after intervention to asses' infraction degree.
Diffusion weighted imaging- DWI for and after intervention with main goal to examine eventually potential of DWI and apparent diffusion coefficient as predictor of volumetric response of uterine fibroid in a prospective group.
Validated Questionnaire UFE-QOL about life quality will be part of study in prospective arm and non-validated self-administered questionnaire is part in the retrospective group.
Laboratory analysis such as, CRP, Creatinin, Estradiol, FSH, AM hormone will be collected in prospective group.
No biological material will be saved.
Collaborating researchers and departments
Department of Radiology, Odense University Hospital
- Senior Hospital Physician Stevo Duvnjak, PhD-student
- Professor and Senior Hospital Physician Poul Erik Andersen, PhD
Department of Gynaecology and Obstetrics, Odense University Hospital
- Senior Hospital Physician Pernille Ravn, PhD-student
OPEN Odense Patient data Explorative Network, Odense University Hospital
- Professor Anders Green, MD, PhD
Publications associated with the project