[Comparison of short-term and long-term efficacy between robot-assisted and thoracoscopy-laparoscopy-assisted radical esophageal cancer surgery].

Objective: To explore the safety and short-term and long-term efficacy of robot-assisted radical esophageal cancer surgery. Methods: A prospective randomized controlled trial was conducted. Patients who were preoperatively diagnosed as stage 0-IIIB esophageal squamous cell carcinoma and suitable for minimally invasive surgery in our hospital from January 1, 2014 to June 30, 2018 were prospectively enrolled. Those of age ≥75 years having received preoperative neoadjuvant therapy, contradicted to anesthesia or operation due to severe complications, with history of thoracotomy or laparotomy, with concurrent malignant tumors, without complete informations or refusing to participate in this study were excluded. Participants were randomly divided into the thoracoscopy-laparoscopy group and the robot group using a random number table in ratio of 1:1. Preoperative clinicopathological data, surgical data and postoperative outcomes were recorded. The patients were followed up mainly by telephone. Follow-up endpoint was recurrence of esophageal cancer and death. Kaplan-Meier method was used to estimate survival rate. The survival difference between the two groups was analyzed using the log-rank test. Results: According to above criteria, a total of 192 esophageal cancer patients were enrolled finally, including 144 males and 48 females with mean age of (61.9±8.6) years. The robot group had 94 cases, including 72 males and 22 females with mean age of (61.3±8.2) years, and the thoracoscopy-laparoscopy group had 98 cases, including 72 males and 26 females with mean age of (62.4±9.1) years. There were no significant differences in baseline data between the two groups (all P>0.05). Operation was abandoned in one case in each group due to extensive pleural cavity metastasis and one case in each group was converted to thoracotomy. The success rate of operation was 97.9% (92/94) in the robot group and 98.0% (96/98) in the thoracoscopy-laparoscopy group (χ(2)=0.002, P=0.996). The number of lymph nodes dissected in the robot group was significantly higher than that in the thoracoscopy-laparoscopy group (29.2±12.5 vs. 22.8±13.3, t=3.433, P=0.001), while there were no significant differences in operative time, intraoperative blood loss, R0 resection rate, postoperative 30-day mortality, postoperative hospital stay, ICU stay, time to withdrawal of chest drainage tube, ICU readmission, and postoperative morbidity of complications between the two groups (all P>0.05). The median follow-up time was 21 (3 to 57) months. During the follow-up, 3 cases and 4 cases were lost, and 2 cases and 3 cases died of other diseases in the robot group and in the thoracoscopy-laparoscopy group respectively. Recurrence occurred in 39 cases during follow-up, including 14 recurrences in the robotic group with 1- and 3-year recurrence-free survival rates of 92.4% and 87.6% respectively and the median recurrence time of 15 (9 to 42) months. There were 25 recurrences in the thoracoscopy-laparoscopy group with 1- and 3-year recurrence-free survival rates of 81.7% and 67.9% respectively and the median recurrence time of 9 (3 to 42) months. There was significant difference in recurrence-free survival between the two groups (χ(2)=4.193, P=0.041). Conclusions: The robotic surgical system has good oncology effect and surgical safety in the radical operation of esophageal cancer, which deserves further research and promotion.目的： 探讨机器人辅助食管癌根治术的安全性及近远期效果。 方法： 采用前瞻性随机对照研究方法。前瞻性纳入2014年1月1日至2018年6月30日期间，术前诊断为0~ⅢB期食管鳞癌、可行微创手术切除的患者，排除≥75岁、术前接受新辅助治疗、术前有严重合并症存在麻醉和（或）手术禁忌者、既往有开胸或开腹手术者、合并其他恶性肿瘤者以及拒绝入组患者研究者。应用随机数字表法将入组患者按1∶1比例随机分为腔镜手术组和机器人手术组，分别行胸腹腔镜手术和机器人手术。记录患者的术前临床病理资料、手术情况和术后近期结局。随访以电话随访为主，随访失效事件为食管癌复发。应用Kaplan-Meier法估算生存率，应用log-rank检验比较两组患者的生存情况。 结果： 剔除入组后发现不符合标准、检测记录不全以及错误的治疗分组患者后，共有192例食管癌患者最终纳入本研究，男性144例，女性48例，年龄（61.9±8.6）岁。其中，机器人手术组94例，男性72例，女性22例，年龄（61.3±8.2）岁；腔镜手术组98例，男性72例，女性26例，年龄（62.4±9.1）岁。两组患者基线资料差异无统计学意义（均P>0.05）。机器人手术组和腔镜手术组各有1例因肿瘤广泛胸膜腔转移而放弃手术，各有1例需中转开胸手术，手术成功率分别为97.9%（92/94）和98.0%（96/98），差异无统计学意义（χ(2)=0.002，P=0.996）。顺利完成手术的92例机器人手术组和96例腔镜手术组患者中，机器人手术组清扫淋巴结数量高于腔镜手术组[（29.2±12.5）枚比（22.8±13.3）枚，t=3.433，P=0.001]，而两组手术时间、术中出血量及R(0)切除率差异均无统计学意义（均P>0.05）；术后住院时间、入住重症监护室时间、术后置胸管时间、再次入住重症监护室比率以及术后并发症发生率之间差异也均无统计学意义（均P>0.05）。中位随访21（3~57）个月，机器人手术组和腔镜手术组分别有3例和4例失访，2例和3例死于其他疾病。共有39例复发，其中机器人手术组有14例复发，1年、3年的累计无复发生存率为92.4%和87.6%，复发时间中位数为15（9~42）个月；腔镜手术组有25例复发，1年、3年的累计无复发生存率为81.7%和67.9%，复发时间中位数为9（3~42）个月。两组之间无复发生存率差异有统计学意义（χ(2)=4.193，P=0.041）。 结论： 机器人外科手术系统在食管癌根治术方面具有较好的肿瘤学效果和手术安全性，值得进一步的研究和推广。.