Randomized Controlled Trial of Uterine Artery Embolization (UAE) Versus High-Intensity-Focused-Ultrasound (HIFU) for Treatment of Patients With Uterine Fibroids
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 85
- Locations
- 2
- Primary Endpoint
- Treatment success rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to 47 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
UAE treatment
After randomization, patient recruited will be arranged to receive UAE treatment. 100 patients will be recruited for UAE treatment
Intervention: UAE (Procedure)
HIFU
After randomization, patient recruited will be arranged to receive HIFU treatment. 100 patients will be recruited for HIFU treatment
Intervention: HIFU (Procedure)
Outcomes
Primary Outcomes
Treatment success rate
Time Frame: 6 months
Technical success of treatment procedure and absence of symptoms of fibroid
Secondary Outcomes
- volume change of the fibroids(6, 12 months after treatment)
- Incidence of procedure related complication(1, 3, 6, 12 months after treatment)
- Degree of infarction of the fibroids(3, 15 months after treatment)
- Vascularity of the fibroids(6, 12 months after treatment)
Investigators
Simon Yu
Professor
Chinese University of Hong Kong