Clinical Trial of Uterine Artery Embolization for Uterine Leiomyoma - Full Text View

Sponsored by:	Sun Yat-sen University
Information provided by:	Sun Yat-sen University
ClinicalTrials.gov Identifier:	NCT00821275

Purpose

The efficacy and safety of uterine artery embolization, as compared with standard surgical methods, for the treatment of symptomatic uterine fibroids remain uncertain. The purpose of this trial is to evaluate the uterine volume and tumor size reduction, symptomatic relief, complication, fertility, ovarian function and quality of life with uterine artery embolization for uterine fibroids comparing with standard surgical methods.

Condition	Intervention	Phase
Leiomyoma	Procedure: Interventional radiological or surgical management	Phase II Phase III

MedlinePlus related topics: Cancer Hysterectomy Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Multi-Center Clinical Trial of Uterine Artery Embolization Treatment of Uterine Leiomyoma

Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:

quality of life [ Time Frame: 1,3,5,10 year. ] [ Designated as safety issue: No ]
pregnant [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

tumor recurrence [ Time Frame: 1,3,5,10 years ] [ Designated as safety issue: No ]
complications [ Time Frame: 3,6,12,24 months ] [ Designated as safety issue: No ]
ovarian functions [ Time Frame: 3,6,12 months, 2,3,5 and 10 years ] [ Designated as safety issue: No ]
symptom relief [ Time Frame: 3,6,12,24 months ] [ Designated as safety issue: No ]
tumour volume [ Time Frame: 3,6,12 18 24 months and 3,5,10 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	900
Study Start Date:	January 2008
Estimated Study Completion Date:	December 2018
Estimated Primary Completion Date:	December 2018 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
pregnancy expectation: Active Comparator The patients who desire for future pregnancy will enroll into this arm , and will be divided into UAE group and SURGERY group.	Procedure: Interventional radiological or surgical management Uterine artery embolization will be done for the patients who enroll into UAE group and desire for future pregancy and reserving uterus.Myomectomy will be performed for the patients who enroll into SURGERY group and desire for future pregancy and reserving uterus.Hysterectomy will be done for the patients who enroll into SURGERY group and don't desire for reserving uterus and/or future pregnancy.
No pregnancy expectation: Active Comparator The patients who don't desire for reserving uterus and/ or future pregnancy will enroll into this arm , and will be divided into UAE group and SURGERY group.	Procedure: Interventional radiological or surgical management Uterine artery embolization will be done for the patients who enroll into UAE group and desire for future pregancy and reserving uterus.Myomectomy will be performed for the patients who enroll into SURGERY group and desire for future pregancy and reserving uterus.Hysterectomy will be done for the patients who enroll into SURGERY group and don't desire for reserving uterus and/or future pregnancy.

Arms

Assigned Interventions

pregnancy expectation: Active Comparator

The patients who desire for future pregnancy will enroll into this arm , and will be divided into UAE group and SURGERY group.

Procedure: Interventional radiological or surgical management

Uterine artery embolization will be done for the patients who enroll into UAE group and desire for future pregancy and reserving uterus.Myomectomy will be performed for the patients who enroll into SURGERY group and desire for future pregancy and reserving uterus.Hysterectomy will be done for the patients who enroll into SURGERY group and don't desire for reserving uterus and/or future pregnancy.

No pregnancy expectation: Active Comparator

The patients who don't desire for reserving uterus and/ or future pregnancy will enroll into this arm , and will be divided into UAE group and SURGERY group.

Procedure: Interventional radiological or surgical management

Uterine artery embolization will be done for the patients who enroll into UAE group and desire for future pregancy and reserving uterus.Myomectomy will be performed for the patients who enroll into SURGERY group and desire for future pregancy and reserving uterus.Hysterectomy will be done for the patients who enroll into SURGERY group and don't desire for reserving uterus and/or future pregnancy.

Eligibility

Ages Eligible for Study:	20 Years to 50 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Clinical diagnosis of symptomatic uterine leiomyoma

Exclusion Criteria:

pregnancy
iodine agent allergy
patient refuse to take part in this trial
tumour size is less than 3cm or beyond 10cm
with endometriosis
with malignant diseases
with abnormal coagulation function which can't restore
with acute inflammatory diseases or acute episode of chronic inflammatory diseases
with severe heart, lung, liver and kidney, et al. organ diseases.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00821275

Locations

China, Guangdong
Sun Yat-sen University
Guangzhou, Guangdong, China, 510630
the first Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510089
Nanfang Hospital of Nanfang medical University
Guangzhou, Guangdong, China, 510000
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 510080

Sponsors and Collaborators

Sun Yat-sen University

Investigators

Study Director:

Hong Shan, M.D., PHD.

The Third Affiliated Hospital of Sun Yat-sen University

More Information

Additional Information:

The Third Affiliated Hospital of Sun Yat-sen University This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	the third Affiliated Hospital of Sun Yat-sen University ( Hong Shan )
Study ID Numbers:	2007026
Study First Received:	January 9, 2009
Last Updated:	January 9, 2009
ClinicalTrials.gov Identifier:	NCT00821275 History of Changes
Health Authority:	China: Ministry of Health

Keywords provided by Sun Yat-sen University:

Uterine Artery Embolization
Leiomyoma
myomectomy
hysterectomy

pregnancy
complication
ovarian function
quality of life

Study placed in the following topic categories:

Neoplasms, Connective and Soft Tissue
Myofibroma
Connective Tissue Diseases
Quality of Life
Leiomyoma

Additional relevant MeSH terms:

Neoplasms, Connective and Soft Tissue
Neoplasms, Muscle Tissue
Neoplasms
Myofibroma

Neoplasms by Histologic Type
Connective Tissue Diseases
Neoplasms, Connective Tissue
Leiomyoma

ClinicalTrials.gov processed this record on May 06, 2009