Clinical Trials Study
Copyright ©The Author(s) 2020. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastrointest Oncol. Jun 15, 2020; 12(6): 651-662
Published online Jun 15, 2020. doi: 10.4251/wjgo.v12.i6.651
Fibrin sealant for esophageal anastomosis: A phase II study
Yao-Bin Lin, Jian-Hua Fu, Yan Huang, Yi-Huai Hu, Kong-Jia Luo, Ke-Xi Wang, Amos Éla 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, the AME Thoracic Surgery Collaborative Group
Yao-Bin Lin, Jian-Hua Fu, Yan Huang, Yi-Huai Hu, Kong-Jia Luo, Ke-Xi Wang, Ji-Yang Chen, Ting Lin, Hong Yang, Department of Thoracic Surgery, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Esophageal Cancer Institute, Sun Yat-sen University Cancer Center, Guangzhou 510060, Guangdong Province, China
Amos Éla Bella, Department of Thoracic Surgery, Avicenne Hospital, Bobigny 93000, France
Amos Éla Bella, Department of Surgery and Specialties, Faculty of Medicine and Biomedical Sciences, University of Yaoundé I, Yaoundé, Cameroon
Dong-Rong Situ, Department of Surgery, Royal Darwin Hospital, Northern Territory 0811, Australia
Xavier B D’Journo, Department of Thoracic Surgery and Diseases of Esophagus, Aix-Marseille University, Hôpital Nord, Marseille 13915, France
Nuria M Novoa, Thoracic Surgery Service, University Hospital of Salamanca, Salamanca 37007, Spain
Alessandro Brunelli, Department of Thoracic Surgery, St James's University Hospital, Leeds LS9 7TF, United Kingdom
Hiran C Fernando, Section of Thoracic Surgery, Inova Fairfax Medical Center, Inova Schar Cancer Institute, Falls Church, VA 22042, United States
Robert J Cerfolio, Department of Cardiothoracic Surgery, New York University Langone Health, New York, NY 10016, United States
Mahmoud Ismail, Department of Thoracic Surgery, Academic Hospital of the Charité–Universitätsmedizin, Humboldt University Berlin, Berlin 10117, Germany
Author contributions: Yang H and Fu JH contributed equally to the supervision of the study and share co-senior authorship; Yang H, Fu JH, and Lin YB conceived of the study and contributed to project design; Yang H, Fu JH, Lin YB, Huang Y, Hu YH, Luo KJ, and Wang KX recruited patients for the study; Lin YB, Huang Y, Hu YH, Chen JY, and Ling T performed data collection; Yang H, Lin YB, Huang Y, Hu YH, Éla Bella A, and Situ DR analyzed and interpreted the data; Lin YB, Huang Y, Hu YH, Luo KJ, Éla Bella A, and Situ DR drafted the manuscript; Yang H, Fu JH, D’Journo XB, Novoa NM, Brunelli A, Fernando HC, Cerfolio RJ, and Ismail M contributed to editing and revising the article; all authors read and approved the final version.
Supported by Fundamental Research Funds for the Central Universities, No. 17ykzd30; National Natural Science Foundation of China, No. 81972614; Guangdong Esophageal Cancer Institute Science and Technology Program, No. M201601; Health &Medical Collaborative Innovation Project of Guangzhou City, China, No. 201803040018.
Institutional review board statement: The study was reviewed and approved by the Ethics Committee of Sun Yat-sen University Cancer Center.
Clinical trial registration statement: This study is registered at https://clinicaltrials.gov (No. NCT03529266).
Informed consent statement: All study participants provided written informed consent prior to study enrolment.
Conflict-of-interest statement: All authors have completed the Unified Competing Interest form and declare the following potential conflicts of interest: Robert J Cerfolio received non-financial support from Intuitive, Inc., Ethicon, Inc., Covidien, Inc., Bovie, Inc., KCL, Inc., Myriad, Inc., Neomend/BARD, Inc., Novartis, Inc., Pinnacle, Inc., TransEnteric, Inc., Medtronic, Inc., Google, Inc., C-SATS video review, Inc., ConMed/AirSeal, Inc., and Aztraseneca, Inc. Robert J Cerfolio is president of ROLO -7 Consulting Firm. The remaining authors declare no conflict of interest.
Data sharing statement: The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to privacy or ethical restrictions.
CONSORT 2010 statement: The manuscript was updated according to the CONSORT 2010.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Corresponding author: Hong Yang, MD, PhD, Associate Professor, Chief, Department of Thoracic Surgery, Sun Yat-sen University Cancer Center, 651 Dongfeng Road East, Guangzhou 510060, Guangdong Province, China. yanghong@sysucc.org.cn
Received: January 20, 2020
Peer-review started: January 20, 2020
First decision: March 24, 2020
Revised: March 28, 2020
Accepted: May 5, 2020
Article in press: May 5, 2020
Published online: June 15, 2020
Processing time: 146 Days and 21.4 Hours
Core Tip

Core tip: The application of fibrin sealant (FS) in esophageal surgery is an attractive therapeutic strategy to prevent anastomotic leakage. In this study, the efficacy and safety of FS were assessed in 57 patients with resectable esophageal or junctional cancer undergoing McKeown esophagectomy. Our findings showed that perioperative sealing with FS was safe and effective for preventing AL in patients with esophageal or junctional cancer, supporting further investigation in phase III trials and implementation in clinical practice.