Huang Jia, Tian Yu, Li Chongwu, Shen Yaofeng, Li Hecheng, Lv Fanzhen, Lin Hao, Lu Peiji, Lin Jules, Lau Christopher, Terra Ricardo Mingarini, Jiang Long, Luo Qingquan
Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China.
Department of Thoracic Surgery, Shanghai Pulmonary Hospital, School of Medicine, Tongji University, Shanghai, China.
Transl Lung Cancer Res. 2021 Nov;10(11):4281-4292. doi: 10.21037/tlcr-21-898.
Our previous study demonstrated the safety and short-term efficacy of robotic-assisted thoracic surgery (RATS) in clinical N2 (c-N2) stage non-small cell lung cancer (NSCLC) patients. From this, the present study was devised, in which the follow-up time and sample size were both extended to explore the long-term efficacy and potential benefit in survival of RATS compared with lobectomy in c-N2 stage NSCLC patients.
Patients with c-N2 NSCLS were randomly assigned in a 1:1 ratio to accept operation through thoracotomy or RATS. The da Vinci Surgical System (Si/Xi) was applied in the RATS group, while conventional lobectomy with a rib-spreading incision was applied in the posterolateral thoracotomy group. Primary endpoint was defined as disease free survival and overall survival (OS) of all recruited patients.
Compared with posterolateral thoracotomy group (N=72), the RATS group (N=76) had a reduced blood loss (P<0.001), decreased drainage duration (P=0.002), and decreased postoperative pain visual analog score (all P<0.001), but increased overall cost (P<0.001). Meanwhile, no difference in the other postoperative complications (such as air leakage, subcutaneous emphysema, atrial fibrillation etc.) was found between the RATS group and the posterolateral thoracotomy group (all P>0.05). Regarding long-term outcome, no difference in disease-free survival (DFS; P=0.925) or OS (P=0.853) was observed between the RATS group and posterolateral thoracotomy group. Subgroup analyses and multivariable Cox regression analyses also found no difference in DFS or OS between the RATS group and posterolateral thoracotomy groups.
RATS reduced intraoperative bleeding, drainage duration, postoperative pain, and achieved similar long-term survival outcomes compared with posterolateral thoracotomy in c-N2 stage NSCLC patients.
Chinese Clinical Trial Registry ChiCTR-INR-17012777.
我们之前的研究证明了机器人辅助胸腔镜手术（RATS）在临床N2（c-N2）期非小细胞肺癌（NSCLC）患者中的安全性和短期疗效。据此，开展了本研究，将随访时间和样本量均进行了延长，以探讨与c-N2期NSCLC患者肺叶切除术相比，RATS的长期疗效及生存潜在获益。
c-N2期NSCLC患者按1:1比例随机分配，分别接受开胸手术或RATS。RATS组应用达芬奇手术系统（Si/Xi），后外侧开胸组则采用传统的撑开肋骨切口行肺叶切除术。主要终点定义为所有入组患者的无病生存期和总生存期（OS）。
与后外侧开胸组（N = 72）相比，RATS组（N = 76）术中出血量减少（P < 0.001）、引流时间缩短（P = 0.002）、术后疼痛视觉模拟评分降低（均P < 0.001），但总体费用增加（P < 0.001）。同时，RATS组与后外侧开胸组在其他术后并发症（如漏气、皮下气肿、房颤等）方面未发现差异（均P > 0.05）。关于长期结局，RATS组与后外侧开胸组在无病生存期（DFS；P = 0.925）或总生存期（OS；P = 0.853）方面未观察到差异。亚组分析和多变量Cox回归分析也发现RATS组与后外侧开胸组在DFS或OS方面无差异。
在c-N2期NSCLC患者中，与后外侧开胸手术相比，RATS减少了术中出血、引流时间和术后疼痛，并获得了相似的长期生存结局。
中国临床试验注册中心ChiCTR-INR-17012777
