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The safety and effectiveness of volumetric magnetic resonance-guided high-intensity focused ultrasound treatment of symptomatic uterine fibroids: early clinical experience in China.

ABSTRACT: BACKGROUND:Uterine fibroids are the most common benign tumor in women, and surgical intervention is still the main fibroid treatment. Patient demands have encouraged development of less-invasive methods such as high-intensity focused ultrasound (HIFU). This study aimed to evaluate the safety and effectiveness of magnetic resonance-guided high-intensity focused ultrasound therapy using a volumetric ablation technique in the treatment of symptomatic uterine fibroids in China. METHODS:One hundred and seven patients were enrolled and treated with magnetic resonance-guided high-intensity focused ultrasound in this study. Clinical efficacy was based on the proportion of patients with fibroid shrinkage (10 % volume reduction or more compared to baseline) at 6 months post treatment as measured with magnetic resonance imaging. The quality of life and symptom outcome was assessed using the uterine fibroid symptom and quality of life questionnaire with symptom severity scoring. Safety was primarily assessed by evaluating the reported adverse events. RESULTS:Ninety nine of the 107 treated patients had fibroid shrinkage at 6 months post treatment. Resulting in an overall 93 % (95 % confidence interval 86-97 %) treatment success rate, p value <0.001; the symptom severity scoring and health-related quality of life at 6 months was statistically different from the screening symptom severity scoring at 0.05 level. Of 366 adverse events reported, there were no study procedure-related or device-related serious adverse events were in the study. CONCLUSIONS:This study demonstrated that the volumetric magnetic resonance-guided high-intensity focused ultrasound device is safe and technically effective and can be utilized in clinically efficient treatments of symptomatic uterine fibroids. TRIAL REGISTRATION:NCT01588899.

SUBMITTER: Chen R

PROVIDER: S-EPMC5094072 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature

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The safety and effectiveness of volumetric magnetic resonance-guided high-intensity focused ultrasound treatment of symptomatic uterine fibroids: early clinical experience in China.

Chen Rui R Keserci Bilgin B Bi Hui H Han Xiaobing X Wang Xiaoying X Bai Wenpei W Wang Yueling Y Yang Xuedong X Yang Jian J Wei Juan J Seppälä Minna M Viitala Antti A Liao Qinping Q

Journal of therapeutic ultrasound 20161103

<h4>Background</h4>Uterine fibroids are the most common benign tumor in women, and surgical intervention is still the main fibroid treatment. Patient demands have encouraged development of less-invasive methods such as high-intensity focused ultrasound (HIFU). This study aimed to evaluate the safety and effectiveness of magnetic resonance-guided high-intensity focused ultrasound therapy using a volumetric ablation technique in the treatment of symptomatic uterine fibroids in China.<h4>Methods</h ...[more]

PMID: 27822376

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Project description:BackgroundMagnetic resonance-guided high-intensity focused ultrasound (MRgHIFU) is a noninvasive uterine-preserving treatment alternative to hysterectomy for women with symptomatic uterine leiomyomas (fibroids). Uterine fibroids commonly occur, have a broad impact on women's health and lifestyle, continue to be the main indication for hysterectomy, and represent a costly public health burden.ObjectivesThe objectives of the analysis were to evaluate patients' eligibility for MRgHIFU treatment of symptomatic uterine fibroids and the technical success, safety, effectiveness, and durability of this treatment. The review also compared the safety and effectiveness of MRgHIFU with other minimally invasive uterine-preserving treatments and surgeries for uterine fibroids.MethodsA literature search was performed on March 27, 2014, using Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid EMBASE, EBSCO Cumulative Index to Nursing & Allied Health Literature (CINAHL), and EBM Reviews, for studies published from January 1, 2000, to March 27, 2014.ResultsThe evidence review identified 2 systematic reviews, 2 RCTs, 45 cohort study reports, and 19 case reports involving HIFU treatment of symptomatic uterine fibroids. Eligibility for MRgHIFU treatment was variable, ranging from 14% to 74%. In clinical cohort studies involving 1,594 patients, 26 major complications (1.6%) were reported. MRgHIFU resulted in statistically and clinically significant reductions in fibroid-related symptoms in studies conducted in 10 countries, although few involved follow-up longer than 1 year. Retreatment rates following MRgHIFU were higher in early clinical studies involving regulated restrictions in the extent of fibroid ablation than in later reports involving near-complete ablation. Emergent interventions, however, were rare. Although a desire for fertility was an exclusion criteria for treatment, spontaneous term pregnancies did occur following HIFU. There were no randomized trials comparing MRgHIFU and other guidance methods, other minimally invasive treatments, or surgeries for symptomatic uterine fibroids. Limitations with MRgHIFU included restricted eligibility, requirement for a dedicated MR device to guide the treatment, lengthy procedure time, and loss of MR opportunity time.ConclusionsFor women failing medical therapy and seeking alternatives to hysterectomy for symptomatic uterine fibroids, MRgHIFU provides a safe and effective, noninvasive, uterine-preserving treatment from which they rapidly recover. The treatment advantages of MRgHIFU are potentially offset by restrictive eligibility, lengthy procedure time, and dependence on availability of an MR device. The lack of comparative evidence between MRgHIFU and other, more established uterine-preserving treatments limits informed decision making among treatment options.

Dataset Information

The safety and effectiveness of volumetric magnetic resonance-guided high-intensity focused ultrasound treatment of symptomatic uterine fibroids: early clinical experience in China.

Publications

The safety and effectiveness of volumetric magnetic resonance-guided high-intensity focused ultrasound treatment of symptomatic uterine fibroids: early clinical experience in China.

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