Fibrin sealant for the prevention of anastomotic leakage after esophagectomy for esophageal or esophagogastric junction cancer:interim report of a prospective,phase III,randomized controlled study

作     者：Zerui Zhao Zhichao Li Weizhao Huang Geng Wang Teng Mao Wenqiang Lv Lin Peng Jiyang Chen Hong Yang 

作者机构：Department of Thoracic SurgeryState Key Laboratory of Oncology in South ChinaCollaborative Innovation Center for Cancer MedicineGuangdong Esophageal Cancer InstituteSun Yat-sen University Cancer CenterGuangzhouGuangdong ProvinceChina Department of Cardiothoracic SurgeryZhongshan Hospital of Sun Yat-Sen University(Zhongshan People’s Hospital)ZhongshanGuangdong ProvinceChina Department of Thoracic SurgeryCancer Hospital of Shantou University Medical CollegeShantouGuangdong ProvinceChina Department of Thoracic SurgeryShanghai Chest HospitalShanghai Jiaotong UniversityShanghaiChina Department of Thoracic SurgeryPeople’s Hospital of JieyangJieyangGuangdong Prov-inceChina Department of Thoracic SurgerySchool of MedicineSichuan Cancer CenterSichuan Cancer Hospital&InstituteUniversity of Electronic Science and Technology of ChinaChengduSichuan ProvinceChina 

出 版 物：《Holistic Integrative Oncology》 (整合肿瘤学（英文）)

年 卷 期：2023年第2卷第1期

页      面：270-277页

学科分类：1002[医学-临床医学] 100214[医学-肿瘤学] 10[医学] 

基　　金：funded by the National Natural Science Foundation of China(grant numbers 81402003 and 81972614) 

主　　题：Esophageal cancer McKeown esophagectomy Fibrin sealant Anastomotic leakage Postoperative complications 

摘      要：Purpose Anastomotic leakage(AL)is one of the most pernicious complications after esophagectomy for patients with esophageal or esophagogastric junction cancer(EC or EJC).The application of fibrin sealant(FS)may be advantageous for reducing the incidence of *** study aims to evaluate the safety and effectiveness of FS in preventing AL in patients undergoing McKeown *** In this multicenter,prospective,randomized controlled trial,we planned to recruit 360 patients aged 18–75 years with resectable EC or EJC and the interim analysis was performed when the number of participants reaches *** assigned to the FS group received McKeown esophagectomy with 2.5ml FS applied to the cervical anastomosis,while patients in the control group received surgery *** primary endpoint was the incidence of cervical AL within the first 3 months *** From February 2019 to November 2021,180 patients were recruited,with 89 in the FS group and 91 in the control *** was no statistically difference between the incidence of AL between the two groups[6.7%(6/89)in the FS vs.14.3%(13/91)in the control group,P=0.16].Complications was comparable(P=0.76)between the FS group(42 of 89,47.2%)and the control group(45 of 91,49.5%).No adverse events related to FS or deaths occurred *** The application of FS intraoperatively is feasible and does not increase the risk of complications,and its effectiveness for the prevention of AL needs to be revalidated after the completion of patient *** registration This trial was registered at ***(NCT03847857)on February 19th,2019.