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机器人辅助与传统微创食管癌切除术治疗可切除食管鳞状细胞癌：一项多中心随机对照试验的早期结果：RAMIE试验

Robot-assisted Versus Conventional Minimally Invasive Esophagectomy for Resectable Esophageal Squamous Cell Carcinoma: Early Results of a Multicenter Randomized Controlled Trial: the RAMIE Trial.

作者信息

Yang Yang, Li Bin, Yi Jun, Hua Rong, Chen Hezhong, Tan Lijie, Li Hecheng, He Yi, Guo Xufeng, Sun Yifeng, Yu Bentong, Li Zhigang

机构信息

Department of Thoracic Surgery, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China.

Department of Cardiothoracic Surgery, Jinling Hospital, Medical School of Nanjing University, Nanjing, Jiangsu, China.

出版信息

Ann Surg. 2022 Apr 1;275(4):646-653. doi: 10.1097/SLA.0000000000005023.

DOI:10.1097/SLA.0000000000005023

PMID:34171870

Abstract

OBJECTIVE

To compare perioperative and long-term outcomes of robot-assisted minimally invasive esophagectomy (RAMIE) and conventional minimally invasive esophagectomy (MIE) in the treatment for patients with esophageal squamous cell carcinoma (ESCC).

SUMMARY BACKGROUND DATA

RAMIE has emerged as an alternative to traditional open or thoracoscopic approaches. Efficacy and safety of RAMIE and MIE in the surgical treatment for ESCC remains uncertain given the lack of high-level clinical evidence.

METHODS

The RAMIE trial was designed as a prospective, multicenter, randomized, controlled clinical trial that compares the efficacy and safety of RAMIE and MIE in the treatment of resectable ESCC. From August 2017 to December 2019, eligible patients were randomly assigned to receive either RAMIE or MIE performed by experienced thoracic surgeons from 6 high-volume centers in China. Intent-to-treat analysis was performed.

RESULTS

Significantly shorter operation time was taken in RAMIE (203.8 vs 244.9 min, P<0.001). Compared with MIE, RAMIE showed improved efficiency of thoracic lymph node dissection in patients who received neoadjuvant therapy (15 vs 12, P = 0.016), as well as higher achievement rate of lymph node dissection along the left recurrent laryngeal nerve (79.5% vs 67.6%, P = 0.001). No difference was found in blood loss, conversion rate, and R0 resection. The 90-day mortality was 0.6% in each group. Overall complications were similar in RAMIE (48.6%) compared with MIE (41.8%) (RR, 1.16; 95% CI, 0.92-1.46; P = 0.196). Besides, the rate of major complications (Clavien-Dindo classification ≥ III) was also comparable (12.2% vs 10.2%, P = 0.551). RAMIE showed similar incidences of pulmonary complications (13.8% vs 14.7%; P = 0.812), anastomotic leakage (12.2% vs 11.3%; P = 0.801), and vocal cord paralysis (32.6% vs 27.1%, P = 0.258) to MIE.

CONCLUSIONS

Early results demonstrate that both RAMIE and MIE are safe and feasible for the treatment of ESCC. RAMIE can achieve shorter operative duration and better lymph node dissection in patients who received neoadjuvant therapy. Long-term results are pending for further follow-up investigations.

TRIAL REGISTRATION

ClinicalTrial.gov Identifier: NCT03094351.

摘要

目的

比较机器人辅助微创食管切除术（RAMIE）与传统微创食管切除术（MIE）治疗食管鳞状细胞癌（ESCC）患者的围手术期及长期疗效。

总结背景数据

RAMIE已成为传统开放或胸腔镜手术方法的替代方案。鉴于缺乏高级别临床证据，RAMIE和MIE在ESCC外科治疗中的疗效和安全性仍不确定。

方法

RAMIE试验设计为一项前瞻性、多中心、随机对照临床试验，比较RAMIE和MIE治疗可切除ESCC的疗效和安全性。2017年8月至2019年12月，符合条件的患者被随机分配接受由中国6个高容量中心经验丰富的胸外科医生实施的RAMIE或MIE手术。进行意向性分析。

结果

RAMIE的手术时间明显更短（203.8分钟对244.9分钟，P<0.001）。与MIE相比，RAMIE在接受新辅助治疗的患者中显示出更高的胸段淋巴结清扫效率（15个对12个，P = 0.016），以及沿左喉返神经的淋巴结清扫完成率更高（79.5%对67.6%，P = 0.001）。在失血、中转率和R0切除方面未发现差异。每组的90天死亡率均为0.6%。RAMIE的总体并发症发生率（48.6%）与MIE（41.8%）相似（RR，1.16；95%CI，0.92 - 1.46；P = 0.196）。此外，严重并发症（Clavien-Dindo分级≥III级）的发生率也相当（12.2%对10.2%，P = 0.551）。RAMIE的肺部并发症（13.8%对14.7%；P = 0.812）、吻合口漏（12.2%对11.3%；P = 0.801）和声带麻痹（32.6%对27.1%，P = 0.258）发生率与MIE相似。