可扩张支架联合新辅助化疗后择期手术治疗梗阻性左半结肠癌的前瞻性、多中心、开放研究初步报告  

Preliminary report on prospective,multicenter,open research of selective surgery after expandable stent combined with neoadjuvant chemotherapy in the treatment of obstructive left hemicolon cancer

作　　者：韩加刚[1] 王振军[1] 戴勇[2] 李小荣[3] 钱群[4] 王贵英[5] 魏广辉[1] 曾维根 马连港 赵宝成[1] 王延磊[2] 杨开焰[3] 丁召[4] 胡旭华[5] Han Jiagang;Wang Zheajun;Dai Yong;Li Xiaorong;Qian Oun;Wang Guiying;Wei Guanghui;Zeng Weigen;Ma Liangang;Zhao Baocheng;Wang Yanlei;Yang Kaiyan;Ding Zhao;Hu Xuhua(Department of General Surgery,Beijing Chaoyang Hosptial,Capital Medical University,Beijing 100020,China;Department of General Surgery,Qilu Hospital,Shandong University,Jinan 250012,China;Department of General Surgery,The Third Xiangya Hospital,Central South University,Changsha 410013,China;Department of General Surgery,Zhongnan Hospital,Wuhan University,Wuhan 430071,China;Department of General Surgery,The Fourth Hospital,Hebei Medical University,Shijiazhuang 050011,China)

机构地区：[1]首都医科大学附属北京朝阳医院普通外科,100020 [2]山东大学齐鲁医院普通外科,济南250012 [3]中南大学湘雅三医院普通外科,长沙410013 [4]武汉大学中南医院普通外科,430071 [5]河北医科大学第四医院普通外科,石家庄050011

出　　处：《中华胃肠外科杂志》2018年第11期1233-1239,共7页Chinese Journal of Gastrointestinal Surgery

基　　金：国家高技术研究发展863计划(2015AA033602);国家自然科学基金(81541101);首都卫生发展科研专项重点攻关(2018-1-2032);北京朝阳医院1351人才培养计划项目(CYXZ-2017-09);北京市属医院科研培育项目(PX2019012).

摘　　要：目的探讨可扩张支架置入联合新辅助化疗后手术治疗完全梗阻性左半结肠癌的安全性和可行性。方法本研究为前瞻性、多中心、开放研究(临床注册号:NCT02972541,首都医科大学附属北京朝阳医院伦理委员批号:2016-科-161-1)。病例入组标准:(1)年龄18~75岁;(2)病理证实为腺癌;(3)临床表现及影像学检查证实为合并完全性肠梗阻的左半结肠癌(距肛门>15cm);(4)影像学评估肿瘤可切除,无远处转移;(5)体力状况ECOG评分≤1分或者Karnofsky评分>70分,经评估可耐受新辅助化疗和手术;(6)6个月内未接受过针对肿瘤的放疗和化疗;(7)骨髓系统和肝肾功能的要求:血红蛋白≥90g/L(14d内未输血)、中性粒细胞≥1.5×10^9/L、血小板≥80×10^9/L,总胆红素≤1.5×正常值上限(ULN)、血清转氨酶≤2.5×ULN,血清肌酐≤1.0×ULN、内生肌酐清除率>50ml/min;(8)签署知情同意书。排除标准:(1)多原发结直肠癌;(2)拒绝手术;(3)合并腹膜炎或者支架置入前存在肠穿孔;(4)其他审查员从登记研究中认为有充分理由是不合格的情况:如有潜在的与临床方案不符的情况。根据上述标准,纳入2015年12月至2017年12月期间,在首都医科大学附属北京朝阳医院(31例)、山东大学齐鲁医院(14例)、中南大学湘雅三医院(13例)、武汉大学中南医院(2例)、河北医科大学第四医院(2例)诊断为完全性梗阻性左半结肠癌,并接受可扩张支架置入的患者总计62例。根据术者操作习惯和患者意愿,分为新辅助化疗组和直接手术组。其中新辅助化疗组(21例)在放置可扩张支架后1~2周,给予2个疗程CapeOX(卡培他滨加奥沙利铂)或3个疗程mFOLFOX6(氟尿嘧啶、奥沙利铂加亚叶酸钙)方案新辅助化疗,化疗结束后3周内接受手术;直接手术组(41例)放置支架后1~2周内接受手术。采用t检验、χ^2检验或Fisher确切概率法比较两组患者的临床基本资料(包括年龄、性别、体质指数、Objective To evaluate the safety and feasibility of neoadjuvant chemotherapy prior elective surgery following self-expanding metallic stents (SEMS)for complete obstructive left hemicolon cancer.Methods This prospective,multicenter,open-labelled trial was approved by the Ethics Committee of Beijing Chaoyang Hospital,Capital Medical University (2016-ke-161-1)and registered in Clinicaltrials.gov (NCT02972541).Inclusion criteria:(1)age between 18and 75years old;(2)adenocarcinoma confirmed by pathology;(3)left hemicolon cancer confirmed by clinical manifestations and imaging examinations with the distance to anal verge >15cm;(4)resectable cancer evaluated by imaging examination without distant metastasis;(5)Eastern Cooperative Oncology Group (ECOG)score ≤or Karnofsky Performance Scale (KPS)>70,indicating tolerance of neoadjuvant chemotherapy and operation;(6)absence of chemotherapy or radiotherapy within past six months; (7)bone marrow system and hepatorenal function:hemoglobin ≥90g/L,neutrophil ≥1.5×109/L, platelet ≥80×10^9/L,total bilirubin ≤1.5×ULN(upper limits of normal),serum transaminase ≤2.5×ULN,serum creatinine ≤1.0×ULN,endogenous creatinine clearance rate >50ml/min;(8)sign for informed consent.Exclusion criteria:(1)multiple primary colorectal cancer;(2)rejection of operation; (3)presenting peritonitis or bowel perforation before SEMS;(4)unqualified conditions proved by inspector from registration data.According to inclusion criteria,62consecutive patients receiving neoadjuvant chemotherapy prior to elective surgery following SEMS for complete obstructive left hemicolon cancer from Beijing Chaoyang Hospital of Capital Medical University (n=31),Qilu Hospital of Shandong University (n=14),the Third Xiangya Hospital of Central South University (n=13), Zhongnan Hospital of Wuhan University (n=2),the Fourth Hospital of Hebei Medical University (n=2) between December 2015and December 2017were prospectively enrolled in this study.Patients were divided into neoadjuvant chemotherapy group and electiv

关 键 词：左半结肠肿瘤 肠梗阻 可扩张支架 新辅助化疗 造口 

分 类 号：R735.35[医药卫生—肿瘤]