老年胃癌病人行腹腔镜和开腹远端胃癌根治术临床疗效的前瞻性研究中期分析

Clinical efficacy of laparoscopic and open distal gastrectomy for gastric cancer in elderly patients:an interim analysis of prospective study

目的探讨老年胃癌病人行腹腔镜和开腹远端胃癌根治术的中期临床疗效。方法采用前瞻性随机对照研究方法。选取2014年9月至2018年5月南方医科大学南方医院收治的102例年龄≥65岁行远端胃癌根治术病人的临床病理资料,剔除6例病人,最终入组96例病人。按照随机数字表法将病人分为两组。病人行腹腔镜远端胃癌根治术设为腹腔镜组;行传统开腹远端胃癌根治术设为开腹组。观察指标:(1)入组病人分组情况。(2)术中情况。(3)术后情况。(4)随访情况。采用门诊和电话方式进行随访,随访内容为术后30 d内并发症发生情况。随访时间截至2018年7月。正态分布的计量资料以x±s表示,组间比较采用t检验;偏态分布的计量资料以M(P25,P75)或M(范围)表示,组间比较采用Mann-Whitney U检验。计数资料以绝对数或百分比表示,组间比较采用χ²检验。等级资料采用非参数Mann-Whitney U检验。结果(1)入组病人分组情况:筛选出符合条件的病人96例,男66例,女30例;中位年龄为69岁,年龄范围为65~85岁。96例病人中,腹腔镜组49例,开腹组47例。(2)术中情况:两组病人均顺利行远端胃癌根治术+D2淋巴结清扫术,腹腔镜组无中转开腹。腹腔镜组病人术中出血量、手术切口长度分别为50 mL(50 mL,100 mL)、(7.1±1.7)cm,开腹组上述指标分别为100 mL(100 mL,200 mL)、(19.1±1.7)cm,两组病人上述指标比较,差异均有统计学意义(Z=-3.779,t=-34.880,P<0.05)。(3)术后情况:腹腔镜组病人淋巴结清扫数目、术后首次下床活动时间、术后首次肛门排气时间、术后首次进食全流质食物时间、术后首次进食半流质食物时间、引流管拔除时间、术后住院时间分别为49枚(35枚,62枚)、1.9 d(1.3 d,2.9 d)、2.6 d(2.2 d,2.9 d)、3.4 d(2.7 d,4.0 d)、5.9 d(4.7 d,7.7 d)、4.9 d(3.5 d,6.8 d)、7.7 d(6.7 d,8.9 d),开腹组病人上述指标分别为40枚(27枚,51枚)、2.5 d(1.8 d,3.3 d)、2.6 d(2.2 d,2.9 d)、3.9 d(2.9 d,5.7 d)、4.9 d(3.9 d,5.9 d)、6.3 d(4.7 d,8.9 d)、8.7 d(6.9 d,11.7 d),两组病人上述指标比较,差异均有统计学意义(Z=-2.354,-2.210,-2.743,-2.474,-2.906,-2.503,-2.359,P<0.05)。(4)随访情况:两组病人均获得术后30 d随访,随访期间,腹腔镜组8例病人发生术后并发症,其中Clavien-Dindo分级Ⅰ级、Ⅱ级、Ⅲb级分别为1、7、0例;开腹组13例病人发生术后并发症,其中Clavien-Dindo分级Ⅰ级、Ⅱ级、Ⅲb级分别为2、10、1例,两组病人上述指标比较,差异均无统计学意义(χ²=1.135,1.973,1.054,P>0.05)。腹腔镜组和开腹组病人术后并发症总发生率分别为16.3%(8/49)和27.7%(13/47),两组病人比较,差异无统计学意义(χ²=1.803,99.7%可信区间为-∞~2.4%,P>0.05),99.7%可信区间上限小于非劣效界值15%,可行中期分析,腹腔镜组并发症发生率非劣效于开腹组。结论老年胃癌病人可行腹腔镜或开腹远端胃癌根治术,腹腔镜手术未增加病人术中、术后并发症;且腹腔镜手术微创化和精细化优势更明显,病人术后恢复快、住院时间短。临床试验注册:在美国clinicaltrials.gov注册,注册号为NCT02246153。

Objective To analyze the interim clinical efficacy of laparoscopic and open distal gastrectomy for gastric cancer in elderly patients.Methods The prospective randomized controlled study was conducted.The clinicopathological data of 102 patients aged≥65 years who underwent distal gastrectomy for gastric cancer in the Nanfang Hospital of Southern Medical University from September 2014 to May 2018 were collected.After excluding 6 patients,96 patients were finally included.Based on random number table,patients were allocated into two groups.Patients undergoing laparoscopic distal gastrectomy were allocated into laparoscopic group,and patients undergoing open distal gastrectomy were allocated into open group,respectively.Obser-vation indicators:(1)grouping situations of the enrolled patients;(2)intraoperative situations;(3)postoperative situations;(4)follow-up.Follow-up using outpatient examination and telephone interview was conducted to detect complications in the postoperative 30 days up to July 2018.Measurement data with normal distribution were represented as Mean±SD,and comparison between groups was analyzed using the t test.Measurement data with skewed distribution were represented as M(P25,P75)or M(range),and comparison between groups was analyzed using the Mann-Whitney U test.Count data were described as absolute numbers or percentages,and comparison between groups was analyzed using the chi-square test.Comparison of ordinal data was analyzed using the non-parameter Mann-Whitney U test.Results(1)Grouping situations of the enrolled patients:a total of 96 patients were selected for eligibility.There were 66 males and 30 females,aged from 65 to 85 years,with a median age of 69 years.There were 49 of 96 patients in the laparoscopic group and 47 patients in the open group.(2)Intraoperative situations:patients in the two groups underwent distal gastrectomy successfully with D2 lymphadenectomy,without intra-operative conversion to laparotomy.The volume of intraoperative blood loss and surgical incision length were 50 mL(50 mL,100 mL)and(7.1±1.7)cm for the laparoscopic group,respectively,versus 100 mL(100 mL,200 mL)and(19.1±1.7)cm for the open group,showing significant differences between the two groups(Z=‒3.779,t=‒34.880,P<0.05).(3)Postoperative situations:the number of lymph node dissected,time to postoperative initial out-of-bed activities,time to postoperative first flatus,time to postoperative first liquid food intake,time to postoperative first semi-liquid food intake,time to drainage tube removal,duration of postoperative hospital stay were 49(35,62),1.9 days(1.3 days,2.9 days),2.6 days(2.2 days,2.9 days),3.4 days(2.7days,4.0 days),5.9 days(4.7 days,7.7 days),4.9 days(3.5 days,6.8 days),7.7 days(6.7 days,8.9 days)for the laparoscopic group,respectively,versus 40(27,51),2.5 days(1.8 days,3.3 days),2.6 days(2.2 days,2.9 days),3.9 days(2.9 days,5.7 days),4.9 days(3.9 days,5.9 days),6.3 days(4.7 days,8.9 days),8.7 days(6.9 days,11.7 days),showing significant differences between the two groups(Z=‒2.354,‒2.210,‒2.743,‒2.474,‒2.906,‒2.503,‒2.359,P<0.05).(4)Follow-up:patients in the two groups received 30 days of follow-up.During the follow-up,8 patients in the laparoscopic group had postoperative complications,including 1 case with Clavien-Dindo gradeⅠcomplications,7 cases with Clavien-Dindo gradeⅡcomplications,and no patient with Clavien-Dindo gradeⅢcomplications.Thirteen patients in the open group had postoperative complications,including 2 cases with Clavien-Dindo gradeⅠcomplications,10 cases with Clavien-Dindo gradeⅡcomplications,and 1 case with Clavien-Dindo gradeⅢcomplications.There was no significant difference in the above indicators between the two groups(χ2=1.135,1.973,1.054,P>0.05).The overall complication rate was 16.3%(8/49)and 27.7%(13/47)for the laparoscopic group and open group,respectively,showing no significant difference between the two groups(χ2=1.803,99.7%confidence interval as‒∞to 2.4%,P>0.05).The upper limit of 99.7%confidence interval was less than non-inferiority level of 15%,interim analysis of which showed that the complication rate of the laparoscopic group was non-inferior to the open group.Conclusion For elderly patients undergoing laparoscopic or open distal gastrectomy for gastric cancer,laparoscopic surgery does not increase intraoperative or postoperative complications,and has advantages of minimally invasiveness,fine operation,quicker recovery,and shorter hospital stay.Registry:this study was registered at clinicaltrials.gov in United States,with the registry number of NCT02246153.