Oxford Clinical HIFU Unit, Churchill Hospital, Oxford, UK.
Br J Radiol. 2012 Oct;85(1018):1363-70. doi: 10.1259/bjr/56737365. Epub 2012 Jun 14.
To assess the safety and feasibility of high-intensity focused ultrasound (HIFU) ablation of liver tumours and to determine whether post-operative MRI correlates with intra-operative imaging.
31 patients were recruited into two ethically approved clinical trials (median age 64; mean BMI 26 kg m(-2)). Patients with liver tumours (primary or metastatic) underwent a single HIFU treatment monitored using intra-operative B-mode ultrasound. Follow-up consisted of radiology and histology (surgical trial) or radiology alone (radiology trial). Radiological follow-up was digital subtraction contrast-enhanced MRI.
Treatment according to protocol was possible in 30 of 31 patients. One treatment was abandoned because of equipment failure. Transient pain and superficial skin burns were seen in 81% (25/31) and 39% (12/31) of patients, respectively. One moderate skin burn occurred. One patient died prior to radiological follow-up. Radiological evidence of ablation was seen in 93% (27/29) of patients. Ablation accuracy was good in 89% (24/27) of patients. In three patients the zone of ablation lay ≤2 mm outside the tumour. The median cross-sectional area (CSA) of the zone of ablation was 5.0 and 5.1 cm(2) using intra-operative and post-operative imaging, respectively. The mean MRI:B-mode CSA ratio was 1.57 [95% confidence interval (CI)=0.57-2.71]. There was positive correlation between MRI and B-mode CSA (Spearman's r=0.48; 95% CI 0.11-0.73; p=0.011) and the slope of linear regression was significantly non-zero (1.23; 95% CI=0.68-1.77; p<0.0001).
HIFU ablation of liver tumours is safe and feasible. HIFU treatment is accurate, and intra-operative assessment of treatment provides an accurate measure of the zone of ablation and correlates well with MRI follow-up.
评估高强度聚焦超声（HIFU）消融肝脏肿瘤的安全性和可行性，并确定术后 MRI 是否与术中影像相关。
将 31 名患者纳入两项伦理批准的临床试验（中位年龄 64 岁；平均 BMI 26kg/m²）。患有肝肿瘤（原发性或转移性）的患者接受单次 HIFU 治疗，并在术中使用 B 型超声监测。随访包括影像学和组织学检查（外科试验）或仅影像学检查（影像学试验）。影像学随访为数字减影对比增强 MRI。
31 名患者中有 30 名按照方案进行了治疗。由于设备故障，一次治疗被放弃。81%（25/31）和 39%（12/31）的患者分别出现短暂疼痛和浅表皮肤灼伤。发生 1 例中度皮肤灼伤。1 例患者在影像学随访前死亡。29 名患者中有 93%（27/29）的患者有消融的影像学证据。消融的准确性在 89%（24/27）的患者中较好。在 3 名患者中，消融区域位于肿瘤外 2mm 以内。术中和术后影像学测量的消融区域的横截面积（CSA）中位数分别为 5.0cm²和 5.1cm²。MRI：B 型 CSA 比值的平均值为 1.57[95%置信区间（CI）=0.57-2.71]。MRI 和 B 型 CSA 之间存在正相关（Spearman's r=0.48；95%CI=0.11-0.73；p=0.011），线性回归的斜率显著不为零（1.23；95%CI=0.68-1.77；p<0.0001）。
HIFU 消融肝脏肿瘤是安全可行的。HIFU 治疗准确，术中评估治疗提供了消融区域的准确测量值，与 MRI 随访相关性良好。
