超声支气管镜引导下双极射频消融术治疗肺癌：首次人类临床试验

2022-04-08 11:41

经皮射频消融术(RFA)是肺肿瘤的一种治疗选择。

SCI

7 April 2022

Endobronchial ultrasound-guided bipolar radiofrequency ablation for lung cancer: a first-in-human clinical trial

(JTCVS, IF: 5.209)

Ishiwata T, Motooka Y, Ujiie H, Inage T, Gregor A, Aragaki M, Chen Z,Kinoshita T, Donahoe L, Yeung J, Cypel M, de Perrot M, Pierre A, Darling G, Waddell T, Keshavjee S,Pal P, Yasufuku K, Endobronchial ultrasound-guided bipolar radiofrequency ablation for lung cancer:a first-in-human clinical trial, The Journal of Thoracic and Cardiovascular Surgery (2022), doi: https://doi.org/10.1016/j.jtcvs.2021.12.059.

OBJECTIVE 目的

Percutaneous radiofrequency ablation (RFA) is a therapeutic option for lung tumors. However, percutaneous approaches have limited access to central lung regions and a relatively high complication rate. To overcome these limitations, a needle-type bipolar RFA device compatible with an endobronchial ultrasound (EBUS) bronchoscope was developed. The aim of this pilot study was to evaluate the immediate-term safety and ablation zone of lung tumor EBUS-guided RFA.

经皮射频消融术(RFA)是肺肿瘤的一种治疗选择。然而，经皮入路进入肺中心区域的途径有限，并发症发生率相对较高。为了克服这些限制，一种与支气管内超声(EBUS)支气管镜兼容的针型双极RFA装置被开发出来。这项初步研究的目的是评估EBUS引导的肺肿瘤RFA的短期安全性和消融区域。

METHODS 方法

This was an ablate-and-resect study in patients scheduled for surgical resection of clinical stage I or II lung cancer or metastatic lung lesions ≥ 1cm that were accessible by EBUS bronchoscope. The RFA electrodes were placed within the lung nodule under EBUS guidance followed by ablation. Bronchoscopy and contrast-enhanced computed tomography were performed to evaluate for post-RFA complications. The resected lung underwent pathological assessment to characterize the ablation zone.

这是一项消融和切除研究，患者计划手术切除临床I期或II期肺癌或转移性肺病变≥1cm，可通过EBUS支气管镜进入。在EBUS引导下将RFA电极置于肺结节内，然后消融。支气管镜和增强CT检查评估射频消融后的并发症。切除的肺进行病理评估以确定消融区特征。

RESULTS 结果

A total of five primary lung cancers were ablated in five separate patients; no patients with metastatic lesions were recruited. For a total energy of 4 kJ (n=3), 6 kJ (n=1), and 8 kJ (n=1) delivered, the ablation time was mean 13.8 min (range,10.3-16.0), 8.4 min, and 15.6 min, respectively, and the maximum ablation diameter was mean 1.8 cm (range,1.3-2.1), 2.7 cm, and 2.6 cm, respectively. No significant immediate post-RFA complications were observed.

在5个单独的患者中，总共有5个原发性肺癌被切除；未招募转移性病变的患者。4 kJ的总能量(n = 3), 6 kJ (n = 1),和8 kJ (n = 1),消融时间平均13.8分钟(范围10.3-16.0)，8.4分钟，15.6分，分别和最大消融直径是1.8厘米(范围1.3-2.1),2.7厘米,2.6厘米。RFA术后无明显并发症。

CONCLUSIONS 结论

EBUS-guided bipolar RFA can ablate lung tumors under real-time ultrasound guidance. EBUS-guided RFA may ultimately represent a minimally invasive therapy for lung cancer in patients unable to tolerate surgery. Longer-term safety will need to be evaluated.

EBUS引导双极RFA可在实时超声引导下消融肺部肿瘤。EBUS引导下的RFA最终可能成为无法耐受手术的肺癌患者的一种微创治疗方法。长期的安全性需要评估。