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机器人辅助与胸腹腔镜联合辅助食管癌根治术的短期和长期疗效比较

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

作者信息

He Z F, Zheng T L, Liu D L, Yang Y, Zhu D Y, Wu K, Wang L P, Zhao S

机构信息

Department of Thoracic Surgery, the First Affiliated Hospital of Zhengzhou University, Zhengzhou 450052, China.

Medical School of Zhengzhou University, Zhengzhou 450052, China.

出版信息

Zhonghua Wei Chang Wai Ke Za Zhi. 2020 Apr 25;23(4):390-395. doi: 10.3760/cma.j.cn.441530-20190327-00120.

Abstract

To explore the safety and short-term and long-term efficacy of robot-assisted radical esophageal cancer surgery. 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. 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 >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, =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, =3.433, =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 >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, =0.041). The robotic surgical system has good oncology effect and surgical safety in the radical operation of esophageal cancer, which deserves further research and promotion.

摘要

探讨机器人辅助根治性食管癌手术的安全性及短期和长期疗效。进行了一项前瞻性随机对照试验。前瞻性纳入2014年1月1日至2018年6月30日在我院术前诊断为0-IIIB期食管鳞状细胞癌且适合微创手术的患者。排除年龄≥75岁、接受过术前新辅助治疗、因严重并发症而麻醉或手术禁忌、有开胸或开腹手术史、合并恶性肿瘤、资料不全或拒绝参加本研究的患者。采用随机数字表法将参与者按1:1的比例随机分为胸腔镜-腹腔镜组和机器人组。记录术前临床病理资料、手术资料及术后结局。主要通过电话对患者进行随访。随访终点为食管癌复发和死亡。采用Kaplan-Meier法估计生存率。采用log-rank检验分析两组间的生存差异。根据上述标准,最终共纳入192例食管癌患者,其中男性144例,女性48例,平均年龄(61.9±8.6)岁。机器人组94例,其中男性72例,女性22例,平均年龄(61.3±8.2)岁;胸腔镜-腹腔镜组98例,其中男性72例,女性26例,平均年龄(62.4±9.1)岁。两组基线资料比较差异无统计学意义(均>0.05)。两组各有1例因广泛胸腔转移放弃手术,两组各有1例中转开胸。机器人组手术成功率为97.9%(92/94),胸腔镜-腹腔镜组为98.0%(96/98)(χ²=0.002,P=0.996)。机器人组清扫淋巴结数目显著高于胸腔镜-腹腔镜组(29.2±12.5 vs. 22.8±13.3,t=3.433,P=0.001),而两组手术时间、术中出血量、R0切除率、术后30天死亡率、术后住院时间、ICU住院时间、胸腔引流管拔除时间、ICU再入院率及术后并发症发生率比较差异均无统计学意义(均>0.05)。中位随访时间为21(3至57)个月。随访期间,机器人组和胸腔镜-腹腔镜组分别失访3例和4例,分别有2例和3例死于其他疾病。随访期间39例复发,其中机器人组14例复发,1年和3年无复发生存率分别为92.4%和87.6%,中位复发时间为15(9至42)个月。胸腔镜-腹腔镜组25例复发,1年和3年无复发生存率分别为81.7%和67.9%,中位复发时间为9(3至42)个月。两组无复发生存率比较差异有统计学意义(χ²=4.193,P=0.041)。机器人手术系统在食管癌根治手术中具有良好的肿瘤学效果和手术安全性,值得进一步研究和推广。

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