Clinical Trial of Uterine Artery Embolization for Uterine Leiomyoma

NCT00821275 | Unknown Phase 2 DMC

• 1 other identifier: 2007026
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Leiomyoma

Keywords

Uterine Artery Embolization; Leiomyoma; myomectomy; hysterectomy; pregnancy; complication; ovarian function; quality of life

Outcome Measures

Primary Outcomes (2)

• quality of life

  1,3,5,10 year.

• pregnant

  3 years

Secondary Outcomes (5)

• tumor recurrence

  1,3,5,10 years

• complications

  3,6,12,24 months

• ovarian functions

  3,6,12 months, 2,3,5 and 10 years

• symptom relief

  3,6,12,24 months

• tumour volume

  3,6,12 18 24 months and 3,5,10 years

Study Arms (2)

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

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

Interventions

Interventional radiological or surgical management PROCEDURE

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; pregnancy expectation

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Clinical diagnosis of symptomatic uterine leiomyoma

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (4)

Nanfang Hospital of Nanfang medical University

Guangzhou, Guangdong, 510000, China

Location

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

Location

the first Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510089, China

Location

Sun Yat-sen University

Guangzhou, Guangdong, 510630, China

Location

Related Links

• The Third Affiliated Hospital of Sun Yat-sen University

MeSH Terms

Conditions

Leiomyoma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Hong Shan, M.D., PHD.

  Third Affiliated Hospital, Sun Yat-Sen University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 9, 2009
• First Posted: January 13, 2009
• Study Start: January 1, 2008
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: January 13, 2009

Record last verified: 2009-01

Locations

CN (4)