Uterine Artery Embolization(UAE) Versus High-Intensity-Focused-Ultrasound(HIFU) for Treatment of Uterine Fibroids
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|ClinicalTrials.gov Identifier: NCT01834703|
Recruitment Status : Terminated
First Posted : April 18, 2013
Last Update Posted : August 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Uterine Fibroids||Procedure: UAE Procedure: HIFU||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||85 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Controlled Trial of Uterine Artery Embolization (UAE) Versus High-Intensity-Focused-Ultrasound (HIFU) for Treatment of Patients With Uterine Fibroids|
|Study Start Date :||May 2009|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
Active Comparator: UAE treatment
After randomization, patient recruited will be arranged to receive UAE treatment. 100 patients will be recruited for UAE treatment
The patient will be admitted into hospital for UAE. UAE was performed with patients under local anesthesia. Embosphere particles (BioSphere Medical) with a size of 500 - 700µm were used in all procedures. Embospheres were mixed with contrast material and saline and injected into each uterine artery until either parenchyma filling of the fibroids had stopped (target embolization) or the main uterine artery was blocked with stasis of contrast material (selective embolization). After the procedure, women were admitted to the gynecology ward for postprocedural care. All patients were advised to stay in the hospital for at least 1 night.
Active Comparator: HIFU
After randomization, patient recruited will be arranged to receive HIFU treatment. 100 patients will be recruited for HIFU treatment
Treatment will be given to the patient in one or more sessions on an outpatient basis. The uterine fibroid will be identified and located with ultrasonography and ablated with HIFU. For lesion beyond 6 cm distance from skin, HIFU is given at a power of 1200-1500 watt for 1500 - 2000 times at each spot, for 50 milli-second each time, at an interval of 100 milli-second, at a spot distance of 1.5cm, a line distance of 1.5cm, and a plane distance of 1.0 -1.5cm; for lesion within 6 cm distance from skin, HIFU is given at a power of 1300±15% Watt for 40 times at each spot, for120 milli-second each time, at an interval of 100 milli-second, at a spot distance of 0.3cm, a line distance of 0.3cm, and a plane distance of 0.8cm.
- Treatment success rate [ Time Frame: 6 months ]Technical success of treatment procedure and absence of symptoms of fibroid
- Incidence of procedure related complication [ Time Frame: 1, 3, 6, 12 months after treatment ]Complications after treatment procedures will be recorded during each hospital admission and during each HIFU treatment session. Major adverse events will be reported. Complications that occur prior to a clinical visit will be documented and graded in each clinical visit at 1, 3, 6 and 12 month after treatment.
- volume change of the fibroids [ Time Frame: 6, 12 months after treatment ]Assessed by 3 Dimensional ultrasonography (USG)
- Degree of infarction of the fibroids [ Time Frame: 3, 15 months after treatment ]Contrast enhanced magnetic resonance imaging (MRI) is used to assess the degree of infarction, which is defined as non-perfused tissue on contrast MRI.
- Vascularity of the fibroids [ Time Frame: 6, 12 months after treatment ]Assessed by contrast enhanced USG. Vascularity of the fibroid will be classified into six categories: 0%, <25%, 25 to 50%, >50 to 75%, >75%, 100%.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01834703
|Department of Imaging and Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong|
|Hong Kong, Hong Kong|
|Department of Obstectrics and Gynaecology, Prince of Wales Hospital|
|Hong Kong, Hong Kong|
|Principal Investigator:||Simon CH Yu, MD, FRCR||Chinese University of Hong Kong|