Clinical efficacy of laparoscopy-assisted radical gastrectomy for gastric cancer

目的 探讨腹腔镜辅助胃癌根治术的临床疗效.方法 采用回顾性队列研究方法.收集2009年5月至2012年12月北京大学肿瘤医院收治的210例行腹腔镜辅助胃癌根治术患者的临床资料.患者术后病理学分期:Ⅰ期52例,Ⅱ期43例,Ⅲ期115例.根据肿瘤所在的部位和范围选择行腹腔镜辅助根治性远端胃大部切除术、近端胃大部切除术或全胃切除术.观察指标:(1)患者总体治疗情况:手术方式、是否中转开腹、手术时间、术中出血量及输血情况、淋巴结清扫数目;术后肛门排气时间、术后住院时间及术后并发症情况;术后病理学检查肿瘤根治程度.(2)Ⅰ、Ⅱ、Ⅲ期胃癌患者临床病理特征[性别、年龄、BMI、美国麻醉医师协会(ASA)分级、内科合并症、肿瘤部位、肿瘤分化程度、脉管癌栓];术中及术后情况(手术方式、中转开腹、手术时间、术中出血量、术中输血、淋巴结清扫数目、术后肛门排气时间、术后住院时间、肿瘤根治程度);术后并发症情况、再次手术、术后30 d内死亡情况;术后随访期间患者死亡情况以及3、5年生存率.(3)评价标准:按照美国癌症联合会(AJCC)及国际抗癌协会(UICC)第7版胃癌TNM分期系统对肿瘤进行分期评估和组织学分级.术后并发症严重程度按照Clavien-Dindo分级标准进行划分.采用门诊、电话或邮件形式进行随访,每半年随访1次.随访内容为术后2年内每半年复查腹盆腔CT、胸部X线片和血液检查,每年复查胃镜;术后2～5年每年复查腹盆腔CT、胸部X线片、胃镜和血液检查.随访时间截至2015年12月31日.总生存时间指患者自手术当日至末次随访或因该疾病死亡的时间.正态分布的计量资料以(x)±s表示,组间比较采用方差分析;偏态分布的计量资料以M(范围)表示,组间比较采用非参数检验.计数资料比较采用x2检验.采用Kaplan-Meier法绘制生存曲线,采用Log-rank检验进行生存分析.结果 (1)总体治疗情况:210例胃癌患者顺利行胃癌根治术,其中行远端胃大部切除术100例,近端胃大部切除术35例,全胃切除术75例.其中198例患者行腹腔镜胃癌根治术,中转开腹患者12例.210例患者手术时间为(258±54) min,术中出血量为(103±86) mL,19例患者接受术中输血.淋巴结清扫数目为(29±12)枚/例.患者术后恢复情况:术后肛门排气时间为(3.8±0.9)d,术后住院时间为(17±7)d,45例患者术后发生并发症,术后30 d内2例患者死亡.肿瘤根治程度:R0切除209例,R1切除1例.(2)不同病理学分期患者的临床病理特征比较:Ⅰ、Ⅱ、Ⅲ期胃癌患者肿瘤位于胃上部、胃中部、胃下部和跨区域分别为9、17、36例,3、9、22例,40、16、47例,0、1、10例;肿瘤分化程度G1级和G2级分别为30、23、23例,G3级和G4级分别为21、19、92例;有脉管癌栓者分别为7、13、69例,上述指标3者比较,差异均有统计学意义(x2=25.990,32.928,35.027,P＜O.05).(3)不同病理学分期患者的术中及术后情况比较:Ⅰ、Ⅱ、Ⅲ期胃癌患者行腹腔镜辅助远端胃大部切除术、近端胃大部切除术、全胃切除术分别为40、20、40例,3、8、24例,9、15、51例;淋巴结清扫数目分别为(26±9)枚/例、(29±13)枚/例、(31±12)枚/例;上述指标3者比较,差异有统计学意义(x2=25.730,F=4.336,P＜0.05).(4)不同病理学分期患者的术后并发症及病死患者比较:Ⅰ、Ⅱ、Ⅲ期胃癌患者术后总体并发症分别为11、8、26例,3者比较,差异无统计学意义(x2=0.301,P＞0.05).(5)不同病理学分期患者的远期生存情况比较:203例患者获得术后随访,随访率为96.67％(203/210),中位随访时间为43个月(1～ 80个月).截至随访结束,68例患者死亡,其中因肿瘤复发死亡60例,术后30 d内因外科并发症死亡2例,其他原因死亡6例.Ⅰ、Ⅱ、Ⅲ期胃癌患者术后3年和5年总体生存率分别为96.1％、87.8％、62.4％和92.9％、77.5％、52.7％,3者生存情况比较,差异有统计学意义(x2=29.071,P ＜0.05).结论 腹腔镜辅助胃癌根治术治疗早期胃癌和进展期胃癌的安全性相当,临床疗效满意.Objective To investigate the clinical efficacy of laparoscopy-assisted radical gastrectomy for gastric cancer.Methods The retrospective cohort study was adopted.The clinical data of 210 patients with gastric cancer who underwent laparoscopy-assisted radical gastrectomy at the Peking University Cancer Hospital between May 2009 and December 2012 were collected.Fifty-two,43 and 115 patients were respectively detected in stage Ⅰ,Ⅱ and Ⅲ of postoperative pathological stage.Laparoscopy-assisted radical distal,proximal and total gastrectomies were selectively performed according to the location and extent of tumors.(1) Overall treatment indicators were observed,including surgical procedure,with or without conversion to open surgery,operation time,volumes of intraoperative blood loss and transfusion,number of lymph node dissected,time to anal exsufflation,duration of hospital stay,occurrence of complications,radical degree of tumors of pathological examination.(2) Other indicators were observed,including pathological features of patients in stage Ⅰ,Ⅱ and Ⅲ [gender,age,body mass index (BMI),scores of American Society of Anesthesiologists (ASA),medicinal complication,location of tumors,degree of tumor differentiation and with or without vascular tumor thrombi],intraoperative and postoperative situations (surgical procedure,conversion to open surgery,operation time,volumes of intraoperative blood loss and transfusion,number of lymph node dissected,time to anal exsufflation,duration of hospital stay and radical degree of tumors),postoperative complications,reoperation,death within postoperative day 30 and during follow-up,3-and 5-year survival rates.(3) Evaluation criteria:stages and classification of tumors were evaluated according to the tumor node metastasis (TNM) classification of malignant tumours (Seventh Edition) published by American Joint Committee on Cancer (AJCC) and Union for International Cancer Control (UICC).Severity of complications was evaluated according to Clavien-Dindo classification.Patients were followed up by outpatient examination,telephone interview and correspondence once every half a year up to December 31,2015,abdominal / pelvic CT,chest X-ray and blood test were performed once every half a year within 2 years and once every year within 2-5 years postoperatively,and gastroscopy was performed once every year.Overall survival time was counted from operation date to end of follow-up or time of death.Measurement data with normal distribution were presented as x ± s and comparison between groups was analyzed using the ANOVA.Measurement data with skewed distribution were presented as M (range) and comparison between groups was analyzed using nonparametric test.Comparisons of count data were analyzed using the chisquare test.Survival curve was drawn by the Kaplan-Meier method,and survival analysis was done using the Logrank test.Results (1) Overall treatment:all the 210 patients underwent successful radical gastrectomy,including 100 undergoing distal gastrectomy,35 undergoing proximal gastrectomy and 75 undergoing total gastrectomy.There were 198 patients undergoing radical gastrectomy and 12 patients converted to open surgery.Operation time,volume of intraoperative blood loss,number of patients with blood transfusion and number of lymph node dissected were (258 ± 54) minutes,(103 ± 86) mL,19 and 29 ± 12,respectively.Postoperative recovery:time to anal exsufflation and duration of hospital stay were (3.8 ± 0.9) days and (17 ± 7) days.Fortyfive patients had postoperative complications and 2 were dead within 30 days postoperatively.R0 and R1 resections were respectively applied to 209 and 1 patients.(2) Comparisons among the patients with the different pathological stage:numbers of patients in stage Ⅰ,Ⅱ and Ⅲ were 9,17 and 36 with tumor located in the upper stomach,3,9 and 22 with tumor located in the middle stomach,40,16 and 47 with tumor located in the lower stomach,0,1 and 10 with tumor located in the cross-region stomach,30,23 and 23 in G1 and G2 of tumor differentiation,21,19 and 92 in G3 and G4 of tumor differentiation,7,13 and 69 with vascular tumor thrombi,respectively,with significant differences in above indicators among the patients in stage Ⅰ,Ⅱ and Ⅲ (x2 =25.990,32.928,35.027,P ＜ 0.05).(3) Intra-and post-operative comparisons among the patients with the different pathological stage:numbers of patients in stage Ⅰ,Ⅱ and Ⅲl were respectively 40,20 and 40 with distal gastrectomy,3,8 and 24 with proximal gastrectomy,9,15 and 51 with total gastrectomy,and number of lymph node dissected were 26 ± 9,29 ± 13 and 31 ± 12 in patients with stage Ⅰ,Ⅱ and Ⅲ,showing significant differences in above indicators among the patients in stage Ⅰ,Ⅱ and Ⅲ (x2 =25.730,F =4.336,P ＜ 0.05).(4) Numbers of patients with postoperative overall complications were 11,8 and 26 in stage Ⅰ,Ⅱ and Ⅲ,showing no significant difference (x2 =0.301,P ＞ 0.05).(5) Of 210 patients,203 were followed up for a median time of 43 months (range,1-80 months) with a follow-up rate of 96.67％ (203/210).Sixty-eight patients were dead till the end of follow-up,including 60 died of recurrence of tumor,2 died of surgical complications and 6 died of other causes.Postoperative 3-,5-year overall survival rates were 96.1％,87.8％,62.4％ and 92.9％,77.5％,52.7％ in patients with stage Ⅰ,Ⅱ and Ⅲ,respectively,with a significant difference (x2 =29.071,P ＜ 0.05).Conclusion Laparoscopy-assisted radical gastrectomy for advanced gastric cancer is at least equivalent to early gastric cancer in the safety,with the satisfactory long-term outcomes.国家高技术研究发展计划(863计划); 国家自然科学基金; 首都临床特色应用研究; 北京市医院管理局临床医学发展专项经费资助(XM201309) National High-tech Research & Development Program of China (863 Program); National Natural Science Foundation of China; Clinical Distinctive Application Program of the Capital; Special Funds for Development of Clinical Medicine of Beijing Municipal Administration of Hospitals中文核心期刊要目总览(PKU)中国科技核心期刊(ISTIC)中国科学引文数据库(CSCD)3234-2401