Clinical Study On Percutaneous Ultrasound Guided Radiofrequency Ablation With Internally Cooled Electrod For Uterine Leiomyoma

Part one Effectiveness and safty study on percutaneous ultrasound guided radiofrequency ablation with internally cooled electrod for uterine leiomyomaObjective: To evaluate the therapeutic efficacy and the safty of uterine fibroid treated with radiofrequency ablation (RFA) by using pathological examination and clinical data.Methods: From Mar 2007 to Jan 2008, 104 patients with 123 uterine fibroids were treated with RFA in Xijing hospital. From these patients, ultrasound guided needle puncture biopsy was performed in 30 patients one week before and after treatment to analyze RFA therapeutic response pathologically using light microscope and transmission electron microscope. 30 fibroids were divided 3 groups according to location of the puncture: group A (center of lesion), group B (marginal), group C (1-cm away from the margin). Control groups were obtained from puncture biopsy before RFA treatment in the same leiomyoma. We observed patient's vital signs, oxygen saturation of hemoglobin during the procedure, skin toxicity, bleeding, pains paresthesia and disfunction in lower limb following treatment; menstrual cycle, menstruation, menorrhea and hypoestrogen related symptoms after the treatment were evaluated.Results: Microscopic examination after RFA showed the cellular membranes were ruptured, and the cytoplasm was overflowed in group A, the smooth-muscle cells contracted and the interstitial spaces dilated in group B and an inter-texture or reticulate appearance characteristic of coagulative necrotic in group C. Electron microscopy showed overall debris and implosion cysts in group A, the chromatin in nucleolus of smooth muscle cell formed rounded aggregates, myofilament structure was damaged and endothelial cell death and red blood cell in together in group B, normal nuclei of smooth muscle cells and normal myofilament in group C. All procedures were performed according to the plan and patients were recruited. During the procedures, vital signs, ergocardiogram, and oxygen saturation of hemoglobin were normal. The major adverse Effects of treatment of uterine fibroids by RFA were virginal discharge and light febris (Fever 38.2±0.4℃in 1-3 days post-procedure mostly). The pains of abdomen was light and the score of Visual analogue scale (VAS) were 3.7±1.1 in 24 hours post–procedure. Penetration/burn injuries of the bowel or bladder, sepsis and peritonitis were not reported.Conclusions: RFA can extracorporeally induce necrosis in target uterine fibroid tissue and surrounding tissue without damage. The evidence directly validates RFA as an effective and safty treatment of uterine fibroid. Part two Evaluation of therapeutic efficacy on percutaneous ultrasound guided radiofrequency ablation with internally cooled electrod for uterine leiomyomaObjective: To study the clinical value of real time contrast enhanced ultrasonography (CEUS) in evaluating the therapeutic efficacy and clinical long term results of percutaneous ultrasound guided radiofrequency ablation (RFA) in the treatment of uterine fibroids by following up the volume change and symptom relief after RFA treatment.Methods: From From Mar 2007 to Jan 2008, 104 consecutive patients with 123 uterine fibroids were treated with RFA. Immediate therapeutic effects were assessed at follow-up with CEUS and CDFI. All patients were followed up to observe long-term therapeutic effects. Leiomyoma mean diameters, volumes and reduction rates 1, 3, 6 and 12 months after RFA treatment were calculated and compared by using one-way ANOVA and Student-Newman-Keuls tests.Improvement in myoma-related symptoms and impacton quality of life were assessed using a validated questionnaire (UFS-QOL).Results: All patients were followed up for 12-26 months (mean, 19.6±2.4 months). After the RFA, on the CEUS, complete tumor ablation was observed in 92.7% of the 114 uterine leiomyomas and residual unablated fibroids were found in 9 leiomyomas (7.3%). Follow-up images showed absence or reduction of blood supply in the lesions after RFA. Results showed that the mean diameter began to decrease one month after RFA, Median reductions in tumor size as a percentage of initial fibroid volume at 1, 3, 6, and 12 months after RFA treatment were 32.4%, 48.3%, 64.1% and 76.7% respectively. 40.4% of women in our study declared significant relief from previous symptoms 12 months after RFA treatment and 66.3% reported completely asymptomatic after RFA treatment. One year after the procedure, 7 women (6.7%) were recurrence of fibroid-related symptoms. Quality-of-life measures showed significant and durable improvement compared with baseline.Conclusions: RFA ablation appears to be an effective treatment of uterine leiomyomain reducing the volume and treating the symptoms.Part three Ultrasound guided ablation treatments for uterine leiomyoma: a comparison between radiofrequency ablation and microwave coagulation treatmentObjective: Comparing the value in clinical practice of ultrasound guided ablation therapies for uterine leiomyoma between using radiofrequency ablation and microwave coagulation treatment.Methods: From Aug 2006 to Jan 2008, percutaneous radiofrequency (RFA) was used to treat 104 cases with 123 fibroids, with a diameter of 4.8±1.4cm (3.0-9.93cm), percutaneous microwave coagulation therapy (MCT) was employed to treat 48 cases with 60 fibroids, with a diameter of 4.7±1.2cm (3.0-7.17cm). To compare RFA and MCT in local ablation effect, effective rate of improve symptoms, recurernce rate in local and the incidence of complications.Results: The fibroid completely ablation rate was 92.7% (114/123) in RFA and 86.7% (52/60) in MCT, which showed no significant difference in statistics(χ2 = 0. 17, P>0.05). The effective rate of improve symptoms was 90.3 %(94/104) in RFA, 87.5% ( 42/48 ) in MCT, which showed no significant difference in statistics(χ2 = 0. 29,P>0.05). The recurernce rate was 5.7% (7/123) in RFA, 15% (9/60) in MCT, which showed significant difference in statistics(χ2= 4.37,P<0.05). There was also no difference in vaginal between the two ablations (x2= 2.61, P>0.05), the light fever was 7.7% (8/104) in RFA and 18.8% (9/48) in MCT, which showed significant difference (χ2 = 4.04, P<0.05). In addition, one microwave antenna was broken in the pull needle.Conclusions: RFA is contemporary ideal therapeutic approaches of interventional ultrasound for uterine leiomyoma. The rate of recurrence and complication were lower in RFA compare with MCT.