背景：視頻輔助胸腔鏡手術(VATS)是一種常用的肺部腫瘤手術切除方式。然而，這些隨機對照試驗從入院到微創手術後一年的臨床療效，安全性和腫瘤結局中獲取的信息有限。
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 是一個平行組多中心隨機對照試驗，在英國 9 個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).
結果：2015 年 7 月至 2019 年 2 月，503 例患者隨機分到視頻輔助胸腔鏡手術組(n=247)和開放肺葉切除術組(n=256)。分配到視頻輔助胸腔鏡手術組的患者疼痛的感覺更少，視覺模擬評分法中位數-0.54（95%置信區間-0.99 至-0.10），盡管他們的鎮痛劑消耗量更少，(平均比率 0.90，95%置信區間 0.80 至 1.01）。出院後疼痛在多個量表上是一致的，包括總體疼痛（中位數-7.19， -10.59 至-3.80），胸痛，長達一年的切口疼痛相對風險度減少了 18%（中位數 0.82; 0.72 至 0.94)。出院後 VATS 組表現出更好的功能恢複持續改善，同時更好的身體功能(主要結局)改善，5 周的中位數為 4.65 (1.69 至 7.61; P=0.002)，全球健康狀況總體改善，中位數為 4.21 (1.62 至 6.79;P = 0.001)。住院時 VATS 組並發症少(RR 0.74、0.66 ~ 0.84;p < 0.001)，嚴重不良事件發生率無差異(RR 0.98, 0.59 ~ 1.63;P = 0.948)。VATS 組的中位住院時間縮短了 1天(4 vs 5 天)，對應的出院風險比(HR)為 1.34,（95%置信區間為 1.09 ~ 1.65;P = 0.006)。出院後 VATS 組嚴重不良事件減少 19% (RR 0.81、0.66 ~ 1.00;P =0.053)和較低的再入院率(分別為29.0%和 35.9%)。在淋巴結疾病患者中，50.9%的 VATS 患者和 45.9%的開放式患者接受了輔助治療。在輔助化療攝入時間上兩組無差異(HR 1.12、0.62 ~ 2.02;p = 0.716)。臨床隨訪和 1年 CT 檢查的複發率相似，VATS 組和開放組分別為 7.7%和 8.1%。無進展生存期(HR 0.74, 0.43 ~ 1.27;p=0.27)和總生存率(HR)分別為 0.67、0.32 ~ 1.40;P =0.282)差異無統計學意義。
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.
結論：肺癌的視頻輔助胸腔鏡肺葉切除術與更少的疼痛、更少的住院並發症和更短的住院時間相關，且在不損害早期腫瘤預後和嚴重不良事件的情況下實現。術後持續良好的功能恢複，改善身體功能，較低的再入院率，無病生存率和 1 年的總生存率無差異。
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.
