Veronesi Giulia, Abbas Abbas El-Sayed, Muriana Piergiorgio, Lembo Rosalba, Bottoni Edoardo, Perroni Gianluca, Testori Alberto, Dieci Elisa, Bakhos Charles T, Car Shamus, Luzzi Luca, Alloisio Marco, Novellis Pierluigi
Department of Thoracic Surgery, IRCCS San Raffaele Scientific Institute, Milan, Italy.
Faculty of Medicine and Surgery, Vita-Salute San Raffaele University, Milan, Italy.
Front Oncol. 2021 Sep 9;11:726408. doi: 10.3389/fonc.2021.726408. eCollection 2021.
We report the results of the first prospective international randomized control trial to compare the perioperative outcome and surgical radicality of the robotic approach with those of traditional video-assisted surgery in the treatment of early-stage lung cancer.
Patients with clinical stage T1-T2, N0-N1 non-small cell lung cancer (NSCLC) were randomly assigned to robotic-assisted thoracoscopic surgery (RATS) or video-assisted thoracic surgery (VATS) resection arms. The primary objective was the incidence of adverse events including complications and conversion to thoracotomy. The secondary objectives included extent of lymph node (LN) dissection and other indicators.
This trial was closed at 83 cases as the probability of concluding in favor of the robot arm for the primary outcome was null according to the observed trend. In this study, we report the results of the analysis conducted on the patients enrolled until trial suspension. Thirty-nine cases were randomized in the VATS arm and 38 in the robotic arm. Six patients were excluded from analysis. Despite finding no difference between the two arms in perioperative complications, conversions, duration of surgery, or duration of postoperative stay, a significantly greater degree of LN assessment by the robotic technique was observed in regards to the median number of sampled LN stations [6, interquartile range (IQR) 4-6 . 4, IQR 3-5; = 0.0002], hilar LNs (7, IQR 5-10 . 4, IQR 2-7; = 0.0003), and mediastinal LNs (7, IQR 5-10 . 5, IQR 3-7; = 0.0001).
The results of this trial demonstrated that RATS was not superior to VATS considering the perioperative outcome for early-stage NSCLC, but the robotic approach allowed an improvement of LN dissection. Further studies are suggested to validate the results of this trial.
clinicaltrials.gov, identifier NCT02804893.
我们报告了第一项前瞻性国际随机对照试验的结果，该试验旨在比较机器人手术与传统电视辅助手术在治疗早期肺癌时的围手术期结果和手术根治性。
将临床分期为T1-T2、N0-N1的非小细胞肺癌（NSCLC）患者随机分配至机器人辅助胸腔镜手术（RATS）组或电视辅助胸腔手术（VATS）切除组。主要目标是不良事件的发生率，包括并发症和中转开胸。次要目标包括淋巴结（LN）清扫范围和其他指标。
由于根据观察到的趋势，得出机器人手术组在主要结局方面更具优势的概率为零，该试验在纳入83例患者后结束。在本研究中，我们报告了对试验暂停前入组患者进行分析的结果。VATS组随机纳入39例患者，机器人手术组随机纳入38例患者。6例患者被排除在分析之外。尽管发现两组在围手术期并发症、中转情况、手术时长或术后住院时长方面无差异，但在采样LN站的中位数[6，四分位间距（IQR）4-6. 4，IQR 3-5；P = 0.0002]、肺门LN（7，IQR 5-10. 4，IQR 2-7；P = 0.0003）和纵隔LN（7，IQR 5-10. 5，IQR 3-7；P = 0.0001）方面，机器人技术的LN评估程度明显更高。
该试验结果表明，对于早期NSCLC，考虑围手术期结果时RATS并不优于VATS，但机器人手术方法可改善LN清扫。建议进一步开展研究以验证该试验结果。
clinicaltrials.gov，标识符NCT02804893。
