背景：视频辅助胸腔镜手术(VATS)是一种常用的肺部肿瘤手术切除方式。然而，这些随机对照试验从入院到微创手术后一年的临床疗效，安全性和肿瘤结局中获取的信息有限。

Background: Video assisted thoracoscopic surgery (VATS) is a popular access for lung cancer resection. However, there is limited information from RCTs from in-hospital to one-year clinical efficacy, safety and oncologic outcomes of a minimal access approach.

方法：VIOLET 是一个平行组多中心随机对照试验，在英国 9 个中心招募了已知或疑似(cT1-3, N0-1 和 M0)肺癌(ISRCTN13472721)。

Methods: VIOLET is a parallel group multi-center RCT conducted in 9 centers in the United Kingdom that recruited participants with known or suspected (cT1-3, N0-1 and M0) lung cancer (ISRCTN13472721).

结果：2015 年 7 月至 2019 年 2 月，503 例患者随机分到视频辅助胸腔镜手术组(n=247)和开放肺叶切除术组(n=256)。分配到视频辅助胸腔镜手术组的患者疼痛的感觉更少，视觉模拟评分法中位数-0.54（95%置信区间-0.99 至-0.10），尽管他们的镇痛剂消耗量更少，(平均比率 0.90，95%置信区间 0.80 至 1.01）。出院后疼痛在多个量表上是一致的，包括总体疼痛（中位数-7.19， -10.59 至-3.80），胸痛，长达一年的切口疼痛相对风险度减少了 18%（中位数 0.82; 0.72 至 0.94)。出院后 VATS 组表现出更好的功能恢复持续改善，同时更好的身体功能(主要结局)改善，5 周的中位数为 4.65 (1.69 至 7.61; P=0.002)，全球健康状况总体改善，中位数为 4.21 (1.62 至 6.79;P = 0.001)。住院时 VATS 组并发症少(RR 0.74、0.66 ~ 0.84;p < 0.001)，严重不良事件发生率无差异(RR 0.98, 0.59 ~ 1.63;P = 0.948)。VATS 组的中位住院时间缩短了 1天(4 vs 5 天)，对应的出院风险比(HR)为 1.34,（95%置信区间为 1.09 ~ 1.65;P = 0.006)。出院后 VATS 组严重不良事件减少 19% (RR 0.81、0.66 ~ 1.00;P =0.053)和较低的再入院率(分别为29.0%和 35.9%)。在淋巴结疾病患者中，50.9%的 VATS 患者和 45.9%的开放式患者接受了辅助治疗。在辅助化疗摄入时间上两组无差异(HR 1.12、0.62 ~ 2.02;p = 0.716)。临床随访和 1年 CT 检查的复发率相似，VATS 组和开放组分别为 7.7%和 8.1%。无进展生存期(HR 0.74, 0.43 ~ 1.27;p=0.27)和总生存率(HR)分别为 0.67、0.32 ~ 1.40;P =0.282)差异无统计学意义。

Results: From July 2015 to February 2019, 503 participants were randomized to VATS (n=247) or open (n=256) lobectomy. Patients allocated to VATS had less pain with a mean difference (MD) in visual analogue score of -0.54 (95%CI -0.99 to -0.10) despite less analgesic consumption (mean ratio 0.90, 95%CI 0.80 to 1.01). After discharge pain was consistent on multiple sub-scales including overall pain (MD -7.19, -10.59 to -3.80), chest pain (MD -4.66, -7.96 to -1.36) and an 18% relative risk (RR) reduction in incision pain (RR 0.82; 0.72 to 0.94) up to one-year. Better functional recovery continued in VATS arm after discharge with better physical function (primary outcome) with MD of 4.65 (1.69 to 7.61; P=0.002) at 5 weeks and overall improvement in global health status with a MD of 4.21 (1.62 to 6.79; P=0.001). In hospital, VATS arm had fewer complications (RR 0.74, 0.66 to 0.84; P<0.001) with no difference in serious adverse events (RR 0.98, 0.59 to 1.63; P=0.948). Median hospital stay was one day shorter in the VATS arm (4 vs 5 days) corresponding to hazard ratio (HR) for discharge of 1.34, 95%CI 1.09 to 1.65; P=0.006). After discharge VATS arm had 19% less serious adverse events (RR 0.81, 0.66 to 1.00; p=0.053) and lower readmission rates (29.0% vs. 35.9% respectively) to one-year. Of those with lymph node disease, 50.9% in the VATS and 45.9% in open arms received adjuvant treatment. There was no difference in the time to uptake of adjuvant chemotherapy (HR 1.12, 0.62 to 2.02; p=0.716). Recurrence with clinical follow up and CT at one-year was similar with 7.7% versus 8.1% in the VATS and open groups respectively. Progression-free survival (HR 0.74, 0.43 to 1.27; p=0.27) and overall survival HR 0.67, 0.32 to 1.40; p=0.282) was not significantly different.

结论：肺癌的视频辅助胸腔镜肺叶切除术与更少的疼痛、更少的住院并发症和更短的住院时间相关，且在不损害早期肿瘤预后和严重不良事件的情况下实现。术后持续良好的功能恢复，改善身体功能，较低的再入院率，无病生存率和 1 年的总生存率无差异。

Conclusions: VATS lobectomy for lung cancer is associated with less pain, fewer in-hospital complications and shorter hospital stay, achieved without any compromise to early oncologic outcomes nor serious adverse events. Superior functional recovery continues in the post-operative period with improved physical function, lower re-admission rates and no difference in disease-free and overall survival up to one-year.