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

Primary Purpose

Uterine Fibroids

Status
Terminated
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
UAE
HIFU
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterine Fibroids

Eligibility Criteria

30 Years - 47 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Imaging and Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong
  • Department of Obstectrics and Gynaecology, Prince of Wales Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

UAE treatment

HIFU

Arm Description

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

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

Outcomes

Primary Outcome Measures

Treatment success rate
Technical success of treatment procedure and absence of symptoms of fibroid

Secondary Outcome Measures

Incidence of procedure related complication
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
Assessed by 3 Dimensional ultrasonography (USG)
Degree of infarction of the fibroids
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
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%.

Full Information

First Posted
April 4, 2013
Last Updated
August 28, 2019
Sponsor
Chinese University of Hong Kong
Collaborators
Prince of Wales Hospital, Shatin, Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT01834703
Brief Title
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

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Terminated
Study Start Date
May 2009 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
Collaborators
Prince of Wales Hospital, Shatin, Hong Kong

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Fibroids

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
UAE treatment
Arm Type
Active Comparator
Arm Description
After randomization, patient recruited will be arranged to receive UAE treatment. 100 patients will be recruited for UAE treatment
Arm Title
HIFU
Arm Type
Active Comparator
Arm Description
After randomization, patient recruited will be arranged to receive HIFU treatment. 100 patients will be recruited for HIFU treatment
Intervention Type
Procedure
Intervention Name(s)
UAE
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
HIFU
Intervention Description
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.
Primary Outcome Measure Information:
Title
Treatment success rate
Description
Technical success of treatment procedure and absence of symptoms of fibroid
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Incidence of procedure related complication
Description
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.
Time Frame
1, 3, 6, 12 months after treatment
Title
volume change of the fibroids
Description
Assessed by 3 Dimensional ultrasonography (USG)
Time Frame
6, 12 months after treatment
Title
Degree of infarction of the fibroids
Description
Contrast enhanced magnetic resonance imaging (MRI) is used to assess the degree of infarction, which is defined as non-perfused tissue on contrast MRI.
Time Frame
3, 15 months after treatment
Title
Vascularity of the fibroids
Description
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%.
Time Frame
6, 12 months after treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
47 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon CH Yu, MD, FRCR
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Imaging and Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong
City
Hong Kong
Country
Hong Kong
Facility Name
Department of Obstectrics and Gynaecology, Prince of Wales Hospital
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
No

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

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