Lung Cancer Research Institute, Sun Yat-sen University, Guangzhou, China; Sun Yat-sen University Cancer Center, Guangzhou, China; State Key Laboratory of Oncology in South China, Guangzhou, China; Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.
Department of Thoracic Surgery, Daping Hospital of the Third Military Medical University, Chongqing, China.
Ann Thorac Surg. 2018 Feb;105(2):386-392. doi: 10.1016/j.athoracsur.2017.08.045. Epub 2017 Dec 2.
Safety and short-term efficacy of video-assisted thoracoscopic surgery (VATS) for early-stage non-small lung cancer (NSCLC) has been demonstrated by observational studies previously. However, these outcomes have never been verified by a large randomized controlled trial (RCT). The aim of our RCT was to confirm that VATS is not inferior or even superior to open operation for early-stage NSCLC in terms of short-term and oncologic efficacy.
The trial was undertaken at five tertiary hospitals. Patients aged between 18 and 75 years with clinically early-stage NSCLC were randomly assigned to the VATS and axillary thoracotomy groups. Lobectomy plus mediastinal lymph node dissection was standard surgical intervention. Because patients continue to be followed up for oncologic outcome, the short-term perioperative outcomes would be reported here.
Between 2008 and 2014, 508 patients were recruited and 425 were eligible for analyses (215 VATS and 210 axillary thoracotomy). Eight VATS procedures were converted to open operation intraoperatively (3.72%). Median operation time with VATS was significantly less than axillary thoracotomy (150 versus 166 minutes, p = 0.009). In addition, VATS was associated with less intraoperative blood loss (p = 0.001). There was no difference for postoperative pleural drainage, length of hospitalization, and rates of morbidity and mortality. Cancer residual margins were found in 1 patient with VATS and 5 with axillary thoracotomy (p = 0.128). The yield of lymph nodes from either surgical approach was similar (p = 0.389).
Our study demonstrates that VATS lobectomy is safe and reliable to treat NSCLCs, and it may be superior to axillary thoracotomy for operation time and intraoperative blood loss. ClinicalTrials.gov identifier: NCT01102517.
先前的观察性研究已经证明,电视辅助胸腔镜手术(VATS)治疗早期非小细胞肺癌(NSCLC)的安全性和短期疗效。然而,这些结果从未被大型随机对照试验(RCT)所证实。我们的 RCT 的目的是确认 VATS 在短期和肿瘤学疗效方面并不逊于或甚至优于开放性手术治疗早期 NSCLC。
该试验在五家三级医院进行。年龄在 18 至 75 岁之间的临床早期 NSCLC 患者被随机分配到 VATS 和腋窝剖胸组。肺叶切除术加纵隔淋巴结清扫术是标准的手术干预。由于患者继续接受肿瘤学结果的随访,因此这里将报告短期围手术期结果。
2008 年至 2014 年期间,共招募了 508 名患者,其中 425 名符合分析条件(215 名 VATS 和 210 名腋窝剖胸)。8 例 VATS 手术术中转为开放性手术(3.72%)。VATS 的中位手术时间明显短于腋窝剖胸(150 分钟对 166 分钟,p=0.009)。此外,VATS 术中出血量较少(p=0.001)。术后胸腔引流、住院时间以及发病率和死亡率无差异。VATS 组有 1 例、腋窝剖胸组有 5 例发现癌症残留边缘(p=0.128)。两种手术方式的淋巴结检出率相似(p=0.389)。
我们的研究表明,VATS 肺叶切除术治疗 NSCLC 安全可靠,在手术时间和术中出血量方面可能优于腋窝剖胸术。临床试验.gov 标识符:NCT01102517。