Single Blinded Randomized Study of Volume Reduction of Uterine Fibroids After Uterine Artery Embolization Versus Computer Tomography or Ultrasound Guided Percutaneous Microwave Ablation Evaluated by Magnetic Resonance Imaging
试验速览
- 阶段
- 2 期
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Fibroma Volume reduction 6 months post treatment
研究概览
简要总结
Uterine fibroids are benign tumors that occur most commonly in women of reproductive age. Symptoms of uterine fibroids may be heavy menstrual bleeding which may lead to anemia, pressure symptoms, bowel symptoms or urinary urgency. In recent years, increasing attention has been paid to the study of minimally invasive methods for treatment. Microwave ablation of myomas and endometrium has been shown to have good effect and acceptability has been high. This study aims to compare the effectiveness, feasibility and acceptability of percutaneous or per vaginal microwave ablation and uterine artery embolization for the treatment of uterine myomas in a randomized single blind study.
Primary outcome
- Volume reduction 6 months post treatment (+/- 15 days) compared to pre treatment measured as mean volume reduction of the 3 largest fibroids evaluated by magnetic
Power calculation
To be able to show a difference between the groups in myoma shrinkage at 6 months of 75% in microwave ablation and 50%[11] in the embolization group with a standard deviation of 25% with a alpha of 0.05 and a power of 80% we would need 16 women in each group and thus need to randomize 32 women.
In order to compensate for loss to follow-up or drop out a total of 36 women will be randomized.
Patients and investigators will not be blinded. The MRI will be performed and evaluated by a blinded radiologist.
After having signed informed consent but before randomization patients will undergo MRI of the uterine fibroids. Patients with a single fibroid measuring more than mean diameter 8cm will be excluded from further participation in the study.
All women included in the study after MRI examination will fill in a PBAC evaluation[7] during the menses preceding treatment. Women will fill a VAS for maximal pain during 1 month prior to treatment.
Microwave ablation will be performed percutaneously or vaginally using a Covidien Emprint microwave ablation system. Embolization will be performed in conscious women with an epidural catheter for pain relief.
At follow up visit 1, 3 months and 6 months post treatment acceptability will be assessed as overall satisfaction of treatment on a scale from 1-7 and if the woman would recommend the treatment to a friend.
A new MRI scan will be performed 6 months post treatment (+/-15 days).
详细描述
Background
Uterine fibroids are benign tumors that occur most commonly in women of reproductive age. Symptoms of uterine fibroids may be heavy menstrual bleeding which may lead to anemia, pressure symptoms, bowel symptoms or urinary urgency. Hysterectomy remains the reference standard in the treatment of uterine fibroids. However, it may cause long-term side effects such as pain and genitovaginal prolapse. It also carries a substantial risk of short term complications such as infections and organ damage. Myomectomy is another conventional treatment, but it is associated with a recurrence rate as high as 20% according to literature. It carries the same short term risks of complications as hysterectomy but at a lower frequency.
In recent years, increasing attention has been paid to the study of minimally invasive or non-invasive therapies with uterine preservation such as uterine arterial embolization (UAE), radiofrequency (RF), microwave treatment and high intensity focused ultrasound (HIFU). RF ablation often requires the aid of a laparoscopic procedure, which is invasive. HIFU is effective in small myomas, but can be time consuming in large myomas with treatments for several hours. Ultrasound or computer tomography guided percutaneous microwave thermal ablation is minimally invasive, has low time requirements, is easy to perform, and has been broadly used for the treatment of solid tumours in organs other than the uterus with favourable effects.
Microwave ablation of myomas and endometrium has been performed in China and Japan. The effect and acceptability has been high. The research team in this study has been to China to study the treatment. We have visited the clinic and studied the procedure as well as talked to patients pre- and post operatively . The equipment at Danderyd Hospital has the same output effects as the equipment in China. Danderyd Hospital as approved the method for use in uterine myomas. However, no randomized comparative study of other minimally invasive methods has been performed.
This study aims to compare the effectiveness, feasibility and acceptability of percutaneous CT- or ultrasound guided microwave ablation and uterine artery embolization for the treatment of uterine myomas in a randomized single blind study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Healthy women aged 30-55 with symptomatic fibromas (pressure, heaviness, bleeding, urgency)
- •Premenopausal
- •Fibromas with a maximum mean diameter of cm evaluated by trans vaginal or abdominal ultrasound
- •Willing to comply with protocol
排除标准
- •Current or future childwish
- •Body Mass Index >35
- •Treatment with anticoagulant
- •Bleeding disorder which leads to increased risk of bleeding
- •Patients with single fibroid more than 6cm mean diameter according to MRI.
- •Contraindication for UAE or general anesthesia
研究组 & 干预措施
Intervention
Microwave treatment
干预措施: Microwave treatment (Device)
Control
Uterine artery embolization
干预措施: uterine artery embolization (Procedure)
结局指标
主要结局
Fibroma Volume reduction 6 months post treatment
时间窗: 6 months post treatment (+/-15 days)
Volume reduction 6 months post treatment (+/- 15 days) compared to pre treatment measured as mean volume reduction of the 3 largest fibroids evaluated by magnetic resonance imaging (MRI)
次要结局
- Symptoms of uterine fibroids(pre-treatment-6 months post treatment)
- Period of hospitalization(post treatment to one year)
- Days of menstrual bleeding(pre and post treatment at 3 months and 6 months)
- Menstrual blood loss(pre and post treatment at 3 and 6 months)
- Period of sick leave(post treament to one year)
- Pain(1-7 days post treatment)
- Quality of lite(pre and post treatment at 3 and 6 months)
- Acceptability(at 3 months and 6 months)
- Use of pain medication(pre-treatment to 6 months post treatment)
- Complications(at any time after enrollment up to 6 months post treatment)
研究者
Helena Kopp Kallner
Senior consultant, PhD
Karolinska Institutet