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  • Title: [Real-world data analysis of 3012 patients undergoing laparoscopic radical gastrectomy in a single center over the past 12 years].
    Author: Wang LJ, Li Z, Wang S, Liu HD, Li QY, Li BW, Xu JH, Ge H, Wang WZ, Li FY, He ZY, Zhang DC, Xu H, Yang L, Xu ZK.
    Journal: Zhonghua Wei Chang Wai Ke Za Zhi; 2022 Aug 25; 25(8):716-725. PubMed ID: 35970806.
    Abstract:
    Objective: To Summarize the safety, clinical outcome and technical evolution of laparoscopic gastric cancer surgery. Methods: A retrospective cohort study was carried out. Clinical data of 3012 patients who underwent laparoscopic radical gastrectomy for gastric cancer from January 2010 to March 2022 at Department of General Surgery, the First Affiliated Hospital of Nanjing Medical University were retrospectively collected and analyzed. Case inclusion criteria were gastric malignancies confirmed by pathology, without distant metastasis by examination before operation and exploration during operation, patients undergoing laparoscopic radical gastrectomy, intact function of important organs and with complete data. Exclusion criteria were patients who underwent emergency gastric cancer resection due to gastric bleeding, perforation or obstruction, etc., tumor found to invade adjacent organs such as pancreas or transverse colon during the operation, conversion to open surgery during the operation, those who had other malignant tumors (except thyroid cancer) within 5 years, and those had severe cardiopulmonary, liver, or kidney insufficiency before surgery. Outcomes included: (1) baseline information of patients; (2) trend of the quantity of laparoscopic radical gastrectomy year by year; (3) evolution of the mode of digestive tract reconstruction; (4) periopertive outcome short-term complication was defined as complication occurring within 30 days after operation and classified accordiny to the clavien-Dindo criteria; and (5) 5-year overall survival. SPSS software was used for statistical analysis. Continuous variables that obeyed the normal distribution were expressed in the form of Mean±SD. Days of hospital stay that did not follow a normal distribution were expressed as median (Q1,Q3), and the Mann-Whiney U test was used for comparison. Discrete variables were expressed as cases (%), and chi-square test or rank sum test was used for comparison between groups. Linear regression analysis was used to analyze the relationship between the amount of surgery and the year of surgery. Kaplan-Meier method and log-rank test were used for survival analysis. Two-tailed P<0.05 was considered as statistically significant. Results: Among the 3012 cases, 2114 were male and 898 were female. The patients' average age at surgery was (61.1±10.7) years old. According to the number of cumulative cases, the patients were divided into three groups: early, intermediate and late, with 1004 patients in each group. The early group consisted of patients undergoing operation from January 2010 to October 2018, the intermediate group consisted of patients undergoing operation from October 2018 to January 2021, and the late group consisted of patients undergoing operation from January 2021 to March 2022. (1) General information: There were 691 (68.8%), 699 (69.6%) and 724 (72.1%) male patients in early, intermediate and late groups respectively; the average age increased from 56.6 years in 2010 to 62.8 years in March 2022. As for the tumor stage T1, T2, T3, T4, there were 49.0%, 14.4%, 23.9% and 12.6% in the early group; 47.5%, 12.9%, 26.9% and 12.6% in the intermediate group; 39.7%, 14.6%, 30.0%, and 15.6% in the late group, respectively. Patients with N0, N1, N2, N3a, N3b stage were 56.8%, 13.7%, 13.4%, 11.0%, and 5.0% in the early group; 55.7%, 12.9%, 12.8%, 11.6%, and 6.9% in the intermediate group; 51.0%, 16.1%, 12.8%, 12.5%, and 7.5% in the late group, respectively. (2) Year-by-year change in the number of gastric cancer operations: From 19 cases per year in 2010 to 786 per year in 2021, the annual number of gastric cancer operations was proportional to the year of operation (y=47.505x, R2=0.67). The proportion of patients with stage I disease showed a fluctuating downward trend over time, while the proportion of patients with stage III disease increased slightly, accounting for 34% until March 2022. (3) Evolution of digestive tract reconstruction methods: Except in 2010, the digestive tract reconstruction method of distal gastrectomy focused on Billroth-II+Braun anastomosis among patients undergoing laparoscopic gastric cancer surgery in other years, whose proportion had gradually increased from less than 20% in 2016 to about 70% after 2021; the gastrointestinal reconstruction methods after total gastrectomy had gradually increased in π anastomosis and overlap anastomosis since 2016, of which π anastomosis reached about 65% in 2019, and overlap anastomosis reached almost 30% in 2020; the anastomosis methods after proximal gastrectomy had been mainly double-channel anastomosis (54%) and esophagogastric anastomosis (30%) since 2016, and double-channel anastomosis accounted for up to 70% in 2019. (4) Operation time: The operation time of early, intermediate and late group was (193.3±49.8) min, (186.9±44.3) min and (206.7±51.4) min respectively. Intermediate group was significantly shorter than early group (t=3.005, P=0.003), while late group was significantly longer than early group (t=5.875, P<0.001) and intermediate group (t=9.180, P<0.001). (5) Postoperative hospital stay: The median length of hospital stay for gastric cancer patients in early, intermediate and late groups was 9 (8, 11) d, 8 (7, 10) d, and 8 (7.5, 10) d respectively. The postoperative hospital stay of intermediate group and late group was significantly shorter than that of early group (Z=-12.467, Z=-5.981, both P<0.001), but there was no significant difference between intermediate group and late group (Z=0.415,P=0.678). (6) Postoperative complication: The morbidity of short-term complication in early, intermediate and late group was 20.4% (205/1004), 16.2% (163/1004), and 16.2% (162/1004) respectively, and above morbidity of intermediate group and late group was significantly lower than that of early group (χ2=5.869, P=0.015; χ2=6.165, P=0.013), while there was no significant difference between intermediate group and late group (χ2=0.004,P=0.952). The morbidity of short-term complication of grade IIIor higher was 8.0% (80/1004), 7.6% (76/1004), and 4.9% (49/1004) in early, intermediate and late group respectively, and above morbidity of late group was significantly lower than that of early and intermediate group (χ2=7.965, P=0.005; χ2=6.219,P=0.013), while there was no significant difference between intermediate group and early group (χ2=0.111,P=0.739). (7) Survival analysis: The follow-up deadline for survival data was December 31, 2021, and the median follow-up time was 29.5 months. The overall 5-year survival rate of all the patients was 74.7%. The 5-year survival rates of stage I, II and III patients were 92.0%, 77.2%, and 40.3% respectively and 5-year survival rates of patients with stage IA, IB, IIA, IIB, IIIA, IIIB and IIIC were 93.2%, 87.8%, 81.1%, 72.7%, 46.2%, 37.1%, and 34.0% respectively. Conclusions: The number of laparoscopic gastric cancer operation in our center is increasing year by year. With the maturity of laparoscopic technology, the morbidity of complication in laparoscopic gastric cancer surgery is decreasing. 目的： 总结分析本中心腹腔镜胃癌手术的安全性、临床疗效及术式演进。 方法： 采用回顾性队列研究的方法，收集分析南京医科大学第一附属医院普通外科自2010年1月至2022年3月期间，接受腹腔镜胃癌根治手术的3 012例患者临床资料。纳入标准为病理证实为胃恶性肿瘤、术前检查及术中探查未发现远处转移、施行腹腔镜胃癌根治术、重要脏器功能完好及病例资料完整者；排除因胃癌出血或穿孔或梗阻等而行急诊胃癌切除术者、术中发现肿瘤侵及邻近脏器如胰腺或横结肠等者、术中中转开放手术者、5年内罹患其他恶性肿瘤（甲状腺癌除外）以及术前伴有严重心肺功能不全或肝肾功能不全者。观察指标与评价标准：（1）患者基本情况；（2）胃癌手术量逐年变化趋势；（3）消化道重建方式的演变；（4）手术及术后情况：包括手术时间、术后住院时间和术后早期并发症，术后早期并发症定义为术后30 d内的并发症，并发症分级按照Clavien-Dindo标准进行分级归类，其中Ⅲ级以上并发症是指需要手术、内镜或放射学干预，或威胁生命或发生死亡；（5）生存分析：生存时间定义为自手术之日至末次随访时间（或死亡时间或随访截止时间）。采用SPSS软件进行统计分析，服从正态分布的连续分布变量以x±s的方式表示。不服从正态分布的住院天数以“M（Q1，Q3）表示，并利用Mann-Whitney U秩和检验进行比较。离散变量以例（%）表示，组间比较采用χ2检验或秩和检验进行对比。采用线性回归分析的方法，分析手术量与手术年份的关系。生存分析采用Kaplan-Meier法及log-rank检验。双尾检验P<0.05视为差异具有统计学意义。 结果： 全组3 012例患者中男性2 114例，女性898例；年龄（61.1±10.7）岁。按累计病例数顺序，将患者平均分为前期、中期和后期3组，每组1 004例患者。前期、中期和后期3组接受手术的时间依次为2010年1月至2018年10月、2018年10月至2021年1月和2021年1月至2022年3月。（1）患者基本情况，3组中男性患者分别为691例（68.8%）、699例（69.6%）和724例（72.1%）；平均年龄从2010年的56.6岁逐年增加至2022年3月的62.8岁。肿瘤T1、T2、T3、T4期患者前期组分别占49.0%、14.4%、23.9%和12.6%；中期组分别为47.5%、12.9%、26.9%和12.6%；后期组分别占39.7%、14.6%、30.0%和15.6%。N0、N1、N2、N3a、N3b期患者前期组分别占56.8%、13.7%、13.4%、11.0%和5.0%；中期组分别占55.7%、12.9%、12.8%、11.6%和6.9%；后期组分别占51.0%、16.1%、12.8%、12.5%和7.5%。（2）胃癌手术量逐年变化趋势：从2010年的19例/年到2021年的786例/年，每年胃癌的手术量与手术年份成正比（y=47.505x，R2=0.67）；病理分期为Ⅰ期患者占比随时间推移呈现波动式下降趋势，而Ⅲ期患者比例略有增加，截至2022年3月占比为34%。（3）消化道重建方式的演变：除2010年外，其他年份行腹腔镜胃癌手术患者中，远端胃切除消化道重建方式侧重于Billroth-Ⅱ+Braun吻合，从2016年不到20%的占比逐渐升至2021年以后的70%左右；全胃切除后消化道重建方式从2016年开始出现π吻合和Overlap吻合逐渐增加，其中π吻合于2019年达到65%左右，Overlap吻合于2020年占比接近30%；近端胃切除术后吻合方式自2016年以来以双通道吻合（占比54%）和食管胃吻合方式（占比30%）为主，双通道吻合在2019年占比达70%。（4）手术时间：前期、中期和后期3组的手术时间分别为（193.3±49.8）min、（186.9±44.3）min和（206.7±51.4）min，中期组比前期组明显缩短（t=3.005，P=0.003），后期组比前期组（t=5.875，P<0.001）、中期组（t=9.180，P<0.001）均明显延长。（5）术后住院时间：前期、中期和后期3组胃癌患者的中位住院天数分别为9（8，11）d、8（7，10）d和8（8，10）d。中期组和后期组的住院天数均显著短于前期组患者（分别Z=-12.467和Z=-5.981，均P<0.001），但中期组与后期组比较，差异无统计学意义（Z=0.415，P=0.678）。（6）术后并发症：前期、中期和后期胃癌患者术后早期并发症发生率分别为20.4%（205/1 004）、16.2%（163/1 004）和16.2%（162/1 004），中期组较前期组有明显降低（χ2=5.869，P=0.015），后期组较前期组也有明显降低（χ2=6.165，P=0.013），但中期组与后期组比较，差异无统计学意义（χ2=0.004，P=0.952）；3组患者术后早期Ⅲ级及以上并发症发生率分别为8.0%（80/1 004）、7.6%（76/1 004）和4.9%（49/1 004），后期组较前期组有明显降低（χ2=7.965，P=0.005），后期组较中期组也有所降低（χ2=6.219，P=0.013），但中期组与前期组比较，差异无统计学意义（χ2=0.111，P=0.739）。（7）生存分析结果：随访截至2021年12月31日，中位随访时间为29.5个月，全组患者整体5年生存率为74.7%，其中Ⅰ、Ⅱ、Ⅲ期患者5年生存率分别为92.0%、77.2%和40.3%。进一步按照TNM分期进行分组，患者ⅠA、ⅠB、ⅡA、ⅡB、ⅢA、ⅢB、ⅢC期5年生存率分别为93.2%、87.8%、81.1%、72.7%、46.2%、37.1%、34.0%。 结论： 腹腔镜胃癌手术量逐年增加，随着累计病例数的增加，腹腔镜胃癌手术的并发症发生率呈下降趋势。.
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