Robot-assisted versus conventional minimally invasive oesophagectomy for oesophageal squamous cell carcinoma (RAMIE): a multicentre, open-label, randomised, phase 3, non-inferiority trial.

However, no large-scale, multicentre, randomised controlled trialhas compared long-term survival as the primary endpoint between robot-assisted oesophagectomy and conventional thoracoscopic oesophagectomy.

然而，尚无大规模、多中心、随机对照试验将机器人辅助食管切除术与传统胸腔镜食管切除术作为主要终点进行长期生存率的比较。

We aimed to confirm the non-inferiority in overall survivalof robot-assisted oesophagectomy over thoracoscopic oesophagectomy in patients with resectable oesophageal squamous cell carcinoma.

我们旨在确认机器人辅助食管切除术在可切除食管鳞状细胞癌患者中的总生存非劣效性优于胸腔镜食管切除术。

Methods

This multicentre, open-label, randomised, controlled, phase 3, non-inferiority trial (RAMIE) was conducted at six hospitals in China.

这项多中心、开放标签、随机、对照、第三阶段、非劣效性试验（RAMIE）在中国六家医院进行。

Patients aged 18-75 years, with biopsy-proven squamous cell carcinoma, Eastern Cooperative Oncology Group scores of 0-2, and with tumour and nodal classifications of cT1-4a, N0-2, M0, or M1 (supraclavicular lymph nodes metastasis) were eligible.

年龄在18-75岁之间，经活检证实为鳞状细胞癌，Eastern Cooperative Oncology Group评分为0-2，肿瘤和淋巴结分期为cT1-4a，N0-2，M0或M1（锁骨上淋巴结转移）的患者符合入选条件。

Patients were randomly assigned (1:1) using a computer-generated randomisation list and stratified by neoadjuvant therapy to robot-assisted oesophagectomy or thoracoscopic oesophagectomy, both with at least two-field lymphadenectomy.

患者通过计算机生成的随机列表按1:1的比例随机分配，并根据新辅助治疗进行分层，接受机器人辅助食管切除术或胸腔镜食管切除术，两者均至少进行两野淋巴结清扫。

The primary endpoint was overall survival, analysed in the intention-to-treatpopulation.

主要终点是总生存，分析了意向治疗人群。

The non-inferiority margin was 9% for 5-year overall survival(the upper limit of 95% CI of the hazard ratio[HR] was 1·33).

非劣效界值为5年总生存率的9%（风险比的95%置信区间上限为1.33）。

Harms were assessed in the per-protocol population, defined as all eligible participants undergoing resection.

在符合方案的人群中评估了不良事件，该人群被定义为所有符合条件并接受切除术的参与者。

This trial was registered with ClinicalTrials.gov, number NCT03094351 and is completed.

该试验已在ClinicalTrials.gov注册，注册号为NCT03094351，并已完成。

Results

Between Aug 2, 2017, and Dec 23, 2019, 362 patients were randomly assigned (183 to robot-assisted oesophagectomy and 179 to thoracoscopic oesophagectomy. 309 (85%) of 362 patients were men and 53 (15%) were women.

2017年8月2日至2019年12月23日期间，362名患者被随机分配（183名接受机器人辅助食管切除术，179名接受胸腔镜食管切除术。362名患者中，309名（85%）为男性，53名（15%）为女性。

Two patients in each group did not undergo resection and were excluded from the per-protocol population.

每组各有两名患者未进行切除手术，并从按方案分析的人群中排除。

Median follow-up of the planned final analysis was 71·5 months (IQR 63·9-81·8).

计划最终分析的中位随访时间为71.5个月（四分位数间距63.9-81.8）。

At 5 years, overall survivalwas 69·4% (95% CI 62·1-75·6) with robot-assisted oesophagectomy versus 56·2% (48·5-63·2) with thoracoscopic oesophagectomy (HR 0·71, 95% CI 0·51-0·97), confirming non-inferiority (one-sided pnon-inferiority=0·0001; exploratory analysis of p=0·032 for superiority).

在5年时，机器人辅助食管切除术的总生存率为69.4%（95%置信区间62.1-75.6），而胸腔镜食管切除术的总生存率为56.2%（48.5-63.2）（风险比0.71，95%置信区间0.51-0.97），确认了非劣效性（单侧p非劣效性=0.0001；探索性分析p=0.032用于优越性）。

Intraoperative conversions to open surgery were similar between study groups (seven [4%] of 181 patients in the robot-assisted group vs six [3%] of 177 in the thoracoscopic group).

研究组之间的术中转为开放手术的比例相似（机器人辅助组181名患者中有7名（4%），胸腔镜组177名患者中有6名（3%））。

Postoperative grade 3 or higher complications were comparable (22 [12%] of 181 patients in the robot-assisted group vs 18 [10%] of 177 in the thoracoscopic group).

术后3级或更高级别的并发症相当（机器人辅助组181名患者中有22名（12%），胸腔镜组177名患者中有18名（10%））。

One treatment-related death occurred in each group.

每组中均发生了一例与治疗相关的死亡。

interpretation

In patients with resectable oesophageal squamous cell carcinoma, robot-assisted oesophagectomy was non-inferior, and seemed superior, to thoracoscopic oesophagectomy in terms of 5-year overall survival.

在可切除食管鳞状细胞癌的患者中，机器人辅助食管切除术在5年总生存方面非劣于且似乎优于胸腔镜下食管切除术。

funding

National Clinical Key Specialty Construction Project, Shanghai Hospital Development Center, and the Program of Shanghai Academic/Technology Research Leader.

国家临床重点专科建设项目，上海市医院发展中心，以及上海市学术/技术研究带头人计划。

translation

For the Chinese translation of the abstract see Supplementary Materials section.

摘要的中文翻译请参见补充材料部分。