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典型文献
Laparoscopic vs.open lower mediastinal lymphadenectomy for Siewert type Ⅱ/Ⅲ adenocarcinoma of esophagogastric junction:An exploratory,observational,prospective,IDEAL stage 2b cohort study(CLASS-10 study)
文献摘要:
Objective:This study aims to verify the feasibility and efficacy of laparoscopic lower mediastinal lymphadenectomy for Siewert type Ⅱ/Ⅲ adenocarcinoma of esophagogastric junction(AEG).Setting:An exploratory,observational,prospective,cohort study will be carried out under the Idea,Development,Exploration,Assessment and Long-term Follow-up(IDEAL)framework(stage 2b).Participants:The study will recruit 1,036 patients with cases of locally advanced AEG(Siewert type Ⅱ/Ⅲ,clinical stage cT2-4aN0-3M0),and 518 will be assigned to either the laparoscopy group or the open group.Interventions:Patients will receive lower mediastinal lymphadenectomy along with either total or proximal gastrectomy.Primary and secondary outcome measures:The primary endpoint is the number of lower mediastinal lymph nodes retrieved,and the secondary endpoints are the surgical safety and prognosis,including intraoperative and postoperative lower-mediastinal-lymphadenectomy-related morbidity and mortality,rate of rehospitalization,R0 resection rate,3-year local recurrence rate,and 3-year overall survival.Conclusions:The study will provide data for the guidance and development of surgical treatment strategies for AEG.Trial registration number:The study has been registered in ClinicalTrials.gov(No.NCT04443478).
文献关键词:
作者姓名:
Shuangxi Li;Xiangji Ying;Fei Shan;Yongning Jia;Zhemin Li;Kan Xue;Rulin Miao;Yinkui Wang;Zhaode Bu;Xiangqian Su;Ziyu Li;Jiafu Ji
作者机构:
Key Laboratory of Carcinogenesis and Translational Research(Ministry of Education/Beijing),Gastrointestinal Cancer Center,Peking University Cancer Hospital&Institute,Beijing 100142,China
引用格式:
[1]Shuangxi Li;Xiangji Ying;Fei Shan;Yongning Jia;Zhemin Li;Kan Xue;Rulin Miao;Yinkui Wang;Zhaode Bu;Xiangqian Su;Ziyu Li;Jiafu Ji-.Laparoscopic vs.open lower mediastinal lymphadenectomy for Siewert type Ⅱ/Ⅲ adenocarcinoma of esophagogastric junction:An exploratory,observational,prospective,IDEAL stage 2b cohort study(CLASS-10 study))[J].中国癌症研究(英文版),2022(04):406-414
A类:
NCT04443478
B类:
Laparoscopic,open,lower,mediastinal,lymphadenectomy,Siewert,type,adenocarcinoma,esophagogastric,junction,An,exploratory,observational,prospective,IDEAL,stage,2b,cohort,study,CLASS,Objective,This,aims,verify,feasibility,efficacy,laparoscopic,AEG,Setting,will,carried,under,Idea,Development,Exploration,Assessment,Long,term,Follow,framework,Participants,recruit,patients,cases,locally,advanced,clinical,cT2,4aN0,3M0,assigned,either,laparoscopy,group,Interventions,Patients,receive,along,total,proximal,gastrectomy,Primary,secondary,outcome,measures,primary,number,nodes,retrieved,endpoints,are,surgical,safety,prognosis,including,intraoperative,postoperative,related,morbidity,mortality,rehospitalization,R0,resection,year,recurrence,overall,survival,Conclusions,provide,data,guidance,development,treatment,strategies,registration,has,been,registered,ClinicalTrials,gov,No
AB值:
0.579807
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