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Fibrin sealant for esophageal anastomosis:A phase II study

World Journal of Gastrointestinal Oncology 2020年第6期12卷 651-662页

作者： Yao-Bin Lin Jian-Hua Fu Yan Huang Yi-Huai Hu Kong-Jia Luo Ke-Xi Wang AmosÉla Bella Dong-Rong Situ Ji-Yang Chen Ting Lin Xavier B D’Journo Nuria M Novoa Alessandro Brunelli Hiran C Fernando Robert J Cerfolio Mahmoud Ismail Hong Yang 无 Department of Thoracic Surgery State Key Laboratory of Oncology in South ChinaCollaborative Innovation Center for Cancer MedicineGuangdong Esophageal Cancer InstituteSun Yat-sen University Cancer CenterGuangzhou 510060Guangdong ProvinceChina Department of Thoracic Surgery Avicenne HospitalBobigny 93000France Department of Surgery and Specialties Faculty of Medicine and Biomedical SciencesUniversity of YaoundéIYaoundéCameroon Department of Surgery Royal Darwin HospitalNorthern Territory 0811Australia Department of Thoracic Surgery and Diseases of Esophagus Aix-Marseille UniversityHôpital NordMarseille 13915France Thoracic Surgery Service University Hospital of SalamancaSalamanca 37007Spain Department of Thoracic Surgery St James's University HospitalLeeds LS97TFUnited Kingdom Section of Thoracic Surgery Inova Fairfax Medical CenterInova Schar Cancer InstituteFalls ChurchVA 22042United States Department of Cardiothoracic Surgery New York University Langone HealthNew YorkNY 10016United States Department of Thoracic Surgery Academic Hospital of the Charité–UniversitätsmedizinHumboldt University BerlinBerlin 10117Germany the AME Thoracic Surgery Collaborative Group

BACKGROUND esophagectomy is a pivotal curative modality for localized esophageal or esophagogastric junction cancer(EC or EJC).Postoperative anastomotic leakage(AL)remains *** use of fibrin sealant(FS)may improve the strength of esophageal anastomosis and reduce the incidence of *** To assess the efficacy and safety of applying FS to prevent AL in patients with EC or *** In this single-arm,phase II trial(*** identifier:NCT03529266),we recruited patients aged 18-80 years with resectable EC or EJC clinically staged as *** open or minimally invasive mckeown esophagectomy was performed with a circular stapled *** performing the anastomosis,2.5 mL of porcine FS was applied *** primary endpoint was the proportion of patients with AL within 3 *** From June 4,2018,to December 29,2018,57 patients were *** the data cutoff date(June 30,2019),three(5.3%)of the 57 patients had developed AL,including two(3.5%)with esophagogastric AL and one(1.8%)with gastric *** incidence of anastomotic stricture and other major postoperative complications was 1.8%and 17.5%,*** median time needed to resume oral feeding after operation was 8 d(Interquartile range:7.0-9.0 d).No adverse events related to FS were *** deaths occurred within 90 d after *** Perioperative sealing with porcine FS appears safe and may prevent AL after esophagectomy in patients with resectable EC or *** phase III studies are warranted.

关键词： Esophageal cancer mckeown esophagectomy Fibrin sealant Anastomotic leakage Postoperative complications Prevention

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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

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Holistic Integrative Oncology 2023年第1期2卷 270-277页

作者： Zerui Zhao Zhichao Li Weizhao Huang Geng Wang Teng Mao Wenqiang Lv Lin Peng Jiyang Chen Hong Yang Department of Thoracic Surgery State Key Laboratory of Oncology in South ChinaCollaborative Innovation Center for Cancer MedicineGuangdong Esophageal Cancer InstituteSun Yat-sen University Cancer CenterGuangzhouGuangdong ProvinceChina Department of Cardiothoracic Surgery Zhongshan Hospital of Sun Yat-Sen University(Zhongshan People’s Hospital)ZhongshanGuangdong ProvinceChina Department of Thoracic Surgery Cancer Hospital of Shantou University Medical CollegeShantouGuangdong ProvinceChina Department of Thoracic Surgery Shanghai Chest HospitalShanghai Jiaotong UniversityShanghaiChina Department of Thoracic Surgery People’s Hospital of JieyangJieyangGuangdong Prov-inceChina Department of Thoracic Surgery School of MedicineSichuan Cancer CenterSichuan Cancer Hospital&InstituteUniversity of Electronic Science and Technology of ChinaChengduSichuan ProvinceChina

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.

关键词： Esophageal cancer mckeown esophagectomy Fibrin sealant Anastomotic leakage Postoperative complications

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