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腹腔镜高强度聚焦超声治疗肾肿瘤:概念验证研究。

Laparoscopic high-intensity focused ultrasound for renal tumours: a proof of concept study.

机构信息

Department of Urology, Churchill Hospital, Oxford, UK.

出版信息

BJU Int. 2011 Apr;107(8):1290-6. doi: 10.1111/j.1464-410X.2010.09620.x. Epub 2010 Sep 21.

Abstract

UNLABELLED

Study Type--Therapy (case series) Level of Evidence What's known on the subject? and What does the study add? Renal cancer is increasingly diagnosed when tumours are small and asymptomatic, during routine abdominal imaging. Whilst surgery is an effective and potentially curative option, it carries a significant risk of complications. Recent work suggests that thermally ablative therapies (RFA, cryotherapy, HIFU) may be suitable minimally invasive treatment options in selected patients. The success of extracorporeal HIFU has been limited by the abdominal wall and rib-cage limiting energy delivery. For this study, a purpose-built laparoscopic HIFU probe was designed to allow direct application of the transducer to the tumour surface, thus facilitating tumour destruction. Successful and accurate tumour destruction was demonstrated, paving the way for further clinical trials, subject to device modifications.

OBJECTIVE

• To test and establish clinical proof of concept for a laparoscopic high-intensity focused ultrasound (HIFU) device that facilitates delivery of ultrasound by direct application of a probe to the tumour surface.

PATIENTS AND METHODS

•   Twelve patients with renal tumours were treated with laparoscopic HIFU using a newly designed probe inserted via an 18-mm laparoscopic port. • HIFU treatment was targeted at a pre-defined proportion of the tumour and immediate laparoscopic partial or radical nephrectomy was then performed.

RESULTS

• No tumour ablation was seen in the first five patients which made modifications in the treatment protocol necessary. After this, definite histological evidence of ablation was seen in the remaining seven patients. • The ablated zones were within the targeted area in all patients and no intra-lesional skipping was seen. • Subcapsular skipping was seen at the probe-tumour interface in two patients with viable tumour cells seen at microscopy. • One patient did not undergo surgical extirpation; subsequent biopsy revealed no viable tumour cells. • There were no intraoperative or postoperative complications directly related to HIFU therapy and patients have reached a mean (range) follow-up of 15 (8-24) months with no evidence of metastatic disease or late complications.

CONCLUSIONS

• Tumour ablation with laparoscopic HIFU is feasible. • Homogenous ablation can be achieved with no vital tissue within the targeted zone. • The technique is associated with low morbidity and may have a role in the definitive management of small tumours.

摘要

背景

研究类型——治疗(病例系列) 证据水平 关于这个主题我们已经了解了什么?以及这项研究有何新发现? 当肿瘤体积较小且无症状时,在常规腹部成像过程中,越来越多地诊断出肾癌。虽然手术是一种有效的治疗方法,有治愈的可能,但它也存在严重并发症的风险。最近的研究表明,热消融治疗(RFA、冷冻治疗、HIFU)可能是适合部分患者的微创治疗选择。由于腹壁和肋骨限制了能量传递,体外 HIFU 的成功应用受到了限制。为了进行这项研究,设计了一种专用的腹腔镜 HIFU 探头,可直接将换能器应用于肿瘤表面,从而促进肿瘤破坏。成功且准确地破坏了肿瘤,为进一步的临床试验铺平了道路,但需要对设备进行修改。

目的

• 测试并建立一种腹腔镜高强度聚焦超声(HIFU)设备的临床概念验证,该设备通过直接将探头应用于肿瘤表面来促进超声的传递。

患者和方法

• 12 名患有肾肿瘤的患者接受了使用新设计的探头通过 18mm 腹腔镜端口插入的腹腔镜 HIFU 治疗。• HIFU 治疗的目标是肿瘤的预定义比例,然后立即进行腹腔镜部分或根治性肾切除术。

结果

• 在前 5 名患者中未观察到肿瘤消融,因此需要修改治疗方案。在此之后,在其余 7 名患者中观察到明确的消融组织学证据。• 在所有患者中,消融区域均位于靶区范围内,未见腔内跳跃现象。• 在探头-肿瘤界面处观察到包膜下跳跃,显微镜下可见活肿瘤细胞。• 1 名患者未进行手术切除;随后的活检显示无存活肿瘤细胞。• 没有与 HIFU 治疗直接相关的术中或术后并发症,患者平均(范围)随访 15(8-24)个月,无转移疾病或晚期并发症的证据。

结论

• 腹腔镜 HIFU 消融肿瘤是可行的。• 可以实现均匀消融,靶区内无存活组织。• 该技术具有低发病率,可能在小肿瘤的确定性治疗中发挥作用。

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