直肠癌经肛全直肠系膜切除术的中期肿瘤学结果:一项前瞻性单中心随机对照研究  

Mid-term oncological outcomes of transanal total mesorectal excision for rectal cancer:a prospective,single center,randomized controlled trial

作　　者：朱永飞 杨选华[1] 滕庆 郭庆 符智勇 范雨诗 黄海霞 敬荣 周冬兵[1] 秦龙 李权林[1] 田云鸿[1] 康亮[2] 任明扬[1] Zhu Yongfei;Yang Xuanhua;Teng Qing;Guo Qing;Fu Zhiyong;Fan Yushi;Huang Haixia;Jing Rong;ZhouDongbing;Qin Long;Li Quanlin;Tian Yunhong;Kang Liang;Ren Mingyang(Department of Gastrointestinal Surgery,Nanchong Central Hospital—Affiliated Hospital of North Sichuan Medical College,Nan-chong,Sichuan 637000,China;Department of Colorectal Surgery,the Sixth Affiliated Hospital of the Sun Yat-sen University,Guangzhou 510655,Guangdong,China)

机构地区：[1]川北医学院附属南充市中心医院胃肠外科,四川南充637000 [2]中山大学附属第六医院结直肠外科,广东广州510655

出　　处：《结直肠肛门外科》2022年第6期551-557,共7页Journal of Colorectal & Anal Surgery

基　　金：国家自然科学基金项目(81401927);四川省卫生健康委员会基金项目(20PJ304);四川省医学科研课题计划(S19040);四川省医学科研课题计划(S21082);四川省医学科研课题计划(S15049);南充市校科技战略合作基金(19SXHZ0452)。

摘　　要：目的比较经肛全直肠系膜切除术(taTME)与腹腔镜全直肠系膜切除术(lapTME)治疗中低位直肠癌的中期肿瘤学结果。方法采用前瞻性随机对照研究,纳入2018年12月至2021年4月期间川北医学院附属南充市中心医院拟行根治性手术治疗的68例中低位直肠癌患者作为研究对象,采用随机数字表法随机分为taTME组(n=33)和lapTME组(n=35)。其中lapTME组中1例患者因术中探查发现已腹膜转移被剔除,最终taTME组纳入33例患者和lapTME组纳入34例患者进行分析。收集并分析两组病理学和随访资料,主要终点为2年OS、2年DFS和肿瘤局部复发、远处转移及死亡情况,次要终点为病理学标本结果。结果两组均无肿瘤远切缘阳性、环周切缘阳性病例。两组的标本长度、肿瘤长径、肿瘤近远切缘距离、环周切缘距离、系膜完整性分级、淋巴结清扫数目、肿瘤病理T分期、N分期、TNM分期比较差异均无统计学意义(均P>0.05)。两组均无失访病例,中位随访时间为31(12,40)个月。截至2022年4月,两组均未发现局部复发病例;taTME组有1例(3.0%)患者和lapTME组有1例(2.9%)患者分别于术后第18个月和第19个月复查时发现肺转移,两组均未发现肝转移及其他远处转移的情况;taTME组1例患者因术后肺部感染致多器官功能衰竭而死亡,lapTME组1例患者于术后1个月因心脏骤停猝死,随访期间两组均未再出现新增死亡病例,taTME组和lapTME组的总死亡率分别是3.0%和2.9%(P=1.000)。taTME组和lapTME组的2年OS分别为97.0%和97.1%(P=0.986),2年DFS分别为93.9%和94.1%(P=0.974)。结论taTME治疗中低位直肠癌安全可行,能达到与lapTME同样的根治效果及良好的中期肿瘤学结果。Objectives To compare mid-term oncological outcomes between transanal total mesorectal excision(taTME)and laparoscopic total mesorectal excision(lapTME)for rectal cancer.Methods This was a prospective randomized controlled trial of 68patients with mid-and low rectal cancer admitted to the Nanchong Central Hospital—Affiliated Hospital of North Sichuan Medical College for planned radical surgery between December 2018 and April 2021.Patients were randomly assigned to the taTME group(n=33)and the lapTME group(n=35)using a random number table.One patient in the lapTME group was found during exploration to have peritoneal metastasis and excluded.The final study included 33 patients in the taTME group and 34 patients in the lapTME group.Pathology and follow-up data were collected and analyzed.Primary endpoints included two-year overall survival(OS),two-year disease-free survival(DFS),local recurrence,distant metastasis,and death.Secondary endpoint was pathology findings.Results No patients in either group showed positive distal resection margin or positive circumferential resection margin.The two groups did not differ significantly in terms of length of specimen,tumor length,distance between proximal and distal resection margin,distance between circumferential resection margin,grade of mesangial integrity,lymph node yield,T stage,N stage,and TNM stage(P>0.05).No patients were lost to follow-up.The Median follow-up was 31(12,40)months.Up to April 2022,no patients had local recurrence.One patient in the taTME group(3.0%)and one in the lapTME group(2.9%)was found to have lung metastasis at 18 and 19 months after surgery,respectively.No liver or other distant metastasis was reported.One patient in the taTME group died due to multiorgan failure caused by postoperative lung infection;one patient in the lapTME group had sudden death due to cardiac arrest at 1 month after surgery;no further death was reported during the follow-up period.The overall mortality rate was 3.0%in the taTME group and 2.9%in the lapTME group(P=1.000)

关 键 词：直肠癌 经肛全直肠系膜切除术 腹腔镜全直肠系膜切除术 中期肿瘤学结果 

分 类 号：R735.37[医药卫生—肿瘤]