Efficacy and safety of novel airway balloon cryoablation system for malignant central airway obstruction: a prospective, multicentre, randomised, non-inferiority study.

This study aimed to evaluate the efficacy and safety of this system.

本研究旨在评估该系统的疗效和安全性。

Methods

This was a prospective, randomised, controlled, non-inferiority study that enrolled MCAO patients at 15 sites in China.

这是一项前瞻性、随机、对照、非劣效性研究，在中国的15个地点招募了大脑中动脉闭塞（MCAO）患者。

Patients were assigned to the ABC group and the ERBOKRYOCA Cryosurgical (EC) system group in a 1:1 ratio.

患者按1:1的比例被分配到ABC组和ERBOKRYOCA冷冻外科（EC）系统组。

Airway tumour debulking with multimodality was permitted before cryoablation.

在冷冻消融之前，允许采用多模式进行气道肿瘤减容。

The primary outcome was the airway patency rate after 6 weeks of intervention with a non-inferiority margin of -10%.

主要结果是在干预后6周的气道通畅率，非劣效性边界为-10%。

Secondary outcomes included modified Medical Research Council (mMRC) Dyspnoea Scale and Karnofsky Performance Scale (KPS) assessment, and the duration of cryoablation.

次要结果包括改良医学研究委员会（mMRC）呼吸困难量表和卡诺夫斯基表现量表（KPS）评估，以及冷冻消融的持续时间。

Results

198 patients were randomised.

共有198名患者被随机分配。

After 6 weeks of intervention, the airway patency rate was 78.49% in the ABC group and 60.92% in the EC group, showing that the difference was over the non-inferiority margin of -10% at 17.58% (95% CI 4.35% to 30.80%), p<0.001.

干预6周后，ABC组的气道通畅率为78.49%，EC组为60.92%，显示出差异超过了非劣效性界限的-10%，为17.58%（95%置信区间4.35%至30.80%），p<0.001。

The mMRC and KPS scores were significantly improved after 3 and 6 weeks in both groups, with no difference.

在两组中，经过3周和6周的干预后，mMRC和KPS评分均显著改善，且两组间无差异。

The duration of cryoablation was shortened remarkably in the ABC group (378.29±399.54 s vs 624.93±443.72 s, p<0.001).

ABC组的冷冻消融时间显著缩短（378.29±399.54秒 vs 624.93±443.72秒，p<0.001）。

The prevalenceof bleeding was similar in the two groups, without life-threatening events.

两组的出血发生率相似，均未出现生命威胁性事件。

Conclusions

The ABC system provided non-inferior and subsequent superior effect in airway patency rate compared with traditional carbon dioxide-driven cryoprobe in MCAO.

在MCAO中，ABC系统在气道通畅率方面提供了非劣效性，并随后显示出优于传统二氧化碳驱动的冷冻探针的效果。

This study supports this novel system as an alternative to cryoablation via bronchoscope for MCAO patients.

本研究支持这种新型系统作为通过支气管镜进行冷冻消融的MCAO患者的替代方案。

trial_registration_number

ChiCTR2100042051.

ChiCTR2100042051