Background Transbronchial cryoablation shows potential as a local therapy for inoperable peripheral lung cancer. However, its clinical application for peripheral pulmonary lesions has not been reported yet. Methods An improved cryoprobe with an 8-mm-long, 1.9-mm-wide cryotip was used. Initially, the safety and effectiveness of this cryoprobe were assessed in an in vivo porcine model. Transbronchial cryoablation with 2 or 3 freeze-thaw cycles (10 min or 15 min in each freezing time) was performed in 18 pigs under CT monitoring. Radiological and pathological examinations were performed to evaluate the extent of cryoablation. Subsequently, nine patients with stage IA peripheral lung cancer or metastases underwent transbronchial cryoablation with this cryoprobe under the guidance of navigation bronchoscopy and cone-beam CT. Technical success, safety and outcomes were assessed. Results 36 cryoablation procedures were performed successfully without any major complications in the porcine model. The extent of cryoablation increased with freezing time and the number of freeze-thaw cycles, which peaked at 24 hours and then gradually decreased. Pathological results showed a change from massive haemorrhage at 24 hours to fibrous hyperplasia with chronic inflammation after 4 weeks. In the clinical trial, 10 cryoablations were performed on 9 tumours with a technical success rate of 100%. One mild treatment-related complication occurred. Of the nine tumours, seven achieved complete ablation, while two exhibited incomplete ablation and subsequent local progression at 6 months. Conclusion Our initial experience indicated that transbronchial cryoablation was a safe and feasible procedure for non-surgical peripheral stage IA lung cancer or pulmonary metastases. Trial registration number ChiCTR2200061544. Data are available upon reasonable request.

中文翻译：

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使用新型细冷冻探针对周围肺实质进行经支气管冷冻消融和初步临床测试


背景 经支气管冷冻消融显示出作为无法手术的周围型肺癌局部治疗的潜力。但其临床应用于周围型肺部病变尚未见报道。方法 使用改进的冷冻探针，其冷冻尖端长 8 毫米、宽 1.9 毫米。最初，在猪体内模型中评估了这种冷冻探针的安全性和有效性。在 CT 监测下，对 18 头猪进行了 2 或 3 个冻融循环（每次冷冻时间 10 分钟或 15 分钟）的经支气管冷冻消融。进行放射学和病理学检查以评估冷冻消融的程度。随后，9名IA期周围型肺癌或转移瘤患者在导航支气管镜和锥形束CT引导下使用该冷冻探头接受了经支气管冷冻消融术。评估了技术成功、安全性和结果。结果 36 次冷冻消融手术在猪模型中成功进行，没有出现任何重大并发症。冷冻消融的程度随着冷冻时间和冻融循环次数的增加而增加，在24小时达到峰值，然后逐渐下降。病理结果显示，从24小时大出血到4周后纤维增生伴慢性炎症。临床试验中，对9个肿瘤进行了10次冷冻消融，技术成功率为100%。发生了一种与治疗相关的轻度并发症。在这九个肿瘤中，七个实现了完全消融，而两个则表现出不完全消融并随后在 6 个月时出现局部进展。结论 我们的初步经验表明，经支气管冷冻消融对于非手术周围型 IA 期肺癌或肺转移瘤是一种安全可行的手术。 试验注册号ChiCTR2200061544。数据可根据合理要求提供。