Clinical trial NCT01834703: Uterine Artery Embolization(UAE) Versus High-Intensity-Focused-Ultrasound(HIFU) for Treatment of Uterine Fibroids
Official title: Randomized Controlled Trial of Uterine Artery Embolization (UAE) Versus High-Intensity-Focused-Ultrasound (HIFU) for Treatment of Patients With Uterine Fibroids
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Uterine Fibroids
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Prince of Wales Hospital, Shatin, Hong Kong
First posted: 2013-04-18
Enrollment: 85
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 47
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Treatment success rate
timeFrame: 6 months
Secondary outcomes:
measure: Incidence of procedure related complication
timeFrame: 1, 3, 6, 12 months after treatment
measure: volume change of the fibroids
timeFrame: 6, 12 months after treatment
measure: Degree of infarction of the fibroids
timeFrame: 3, 15 months after treatment
measure: Vascularity of the fibroids
timeFrame: 6, 12 months after treatment
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Department of Imaging and Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong
city: Hong Kong
country: Hong Kong
facility: Department of Obstectrics and Gynaecology, Prince of Wales Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: Simon CH Yu, MD, FRCR
role: PRINCIPAL_INVESTIGATOR
References: