Uterine Artery Embolization(UAE) Versus High-Intensity-Focused-Ultrasound(HIFU) for Treatment of Uterine Fibroids

Not Applicable

Terminated

Brief Summary: This study aimed to evaluate the clinical effectiveness and adverse effects of Uterine Artery Embolization (UAE), High-Intensity-Focused-Ultrasound (HIFU) in treating patients with uterine fibroid.

Detailed Description: The usual management for symptomatic uterine fibroid is surgery (myomectomy or hysterectomy), in the current study, uterine artery embolization (UAE) is a form of non-surgical and minimally invasive treatment, High-Intensity-Focused-Ultrasound (HIFU) is a form of non-invasive treatment that can be completed as an out-patient within hours. Embolization causes ischaemia and shrinkage of the fibroid and therefore symptomatic relieve. HIFU is a medical technology that has been used for cancer treatment. Energy is delivered from outside the body in a non-invasive manner to produce heat energy that causes necrosis and shrinkage of the uterine fibroid thereby relieves the symptoms due to the fibroid. It does not involve radiation. The clinical effectiveness of HIFU for uterine fibroid is unknown, however, based on the knowledge of the clinical effectiveness of HIFU on liver cancer and pancreatic cancer, there is reasonable ground to believe that HIFU is effective for uterine fibroid.

Recruitment & Eligibility

Inclusion Criteria

Female gender
Age between 30 and 47
Pre or peri menopausal with Follicle-stimulating hormone (FSH) less than 40 mIU/ml
Weight less than 140kg (or 310lbs) and Body Mass Index (BMI) less than 33
Cervical cytology no more severe than low grade SIL
Negative urine pregnancy test
Uterine size less than 24 weeks based on physical exam assessment
History of uterine leiomyoma causing symptoms of bleeding, pressure, or pain. Excessive uterine bleeding will be evidenced by either one of the following-profuse bleeding with flooding or clots or repetitive periods lasting for more than 8 days; or anemia due to acute or chronic blood loss OR pelvic discomfort caused by leiomyomata, either acute and severe or chronic lower abdominal or low back pressure or bladder pressure with urinary frequency not due to urinary tract infection
Dominant intramural fibroid greater than or equal to 3 cm and less than or equal to 12 cm on imaging.
Good health other than history of leiomyomas. Chronic medications may be acceptable at the discretion of the research team.
No future fertility wish.
Are using abstinence, mechanical (condoms, diaphragms) or sterilization methods of contraception and are willing to continue using them throughout the study.
Willing and able to give informed consent.
Willing and able to comply with study requirements.
Normal menstrual cycle with endometrial pathology excluded
Normal renal function
Normal liver function
Platelet count greater than 50 K/microL
Normal coagulation profile

Exclusion Criteria

Significant abnormalities in the history, physical or laboratory examination
History of or current thromboembolic event (deep vein thrombosis, pulmonary embolus, stroke)
Other pelvic mass indicated by history or MR imaging such as endometriosis, ovarian tumor, acute or chronic pelvic inflammatory disease
Desire for future pregnancy
Pregnant or Positive pregnancy test
Lactation
Unexplained vaginal bleeding
Untreated severe cervical dysplasia
Intrauterine device
Need for interval use of narcotics
Extensive scarring along anterior lower abdominal wall (greater than 50% of area) or scar tissue or surgical clips in the direct path of the HIFU
Pedunculated submucosal or subserosal fibroid of size ≧5cm and with a stalk less than 25% of the maximal fibroid diameter.
Genetic causes of leiomyomata
Known recent rapid growth of fibroids, defined as a doubling in size in 6 months
Patient unwilling to receive non-surgical treatment
Contraindication to MRI due to severe claustrophobia or implanted metallic device.

Arm && Interventions

Group	Intervention	Description
UAE treatment	UAE	After randomization, patient recruited will be arranged to receive UAE treatment. 100 patients will be recruited for UAE treatment
HIFU	HIFU	After randomization, patient recruited will be arranged to receive HIFU treatment. 100 patients will be recruited for HIFU treatment

Primary Outcome Measures

Name	Time	Method
Treatment success rate	6 months	Technical success of treatment procedure and absence of symptoms of fibroid

Secondary Outcome Measures

Name	Time	Method
volume change of the fibroids	6, 12 months after treatment	Assessed by 3 Dimensional ultrasonography (USG)
Incidence of procedure related complication	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.
Degree of infarction of the fibroids	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	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%.

Locations (2): Department of Imaging and Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong
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Hong Kong, Hong Kong
Department of Obstectrics and Gynaecology, Prince of Wales Hospital
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Hong Kong, Hong Kong