Fibrin sealant for esophageal anastomosis: A phase II study
| Autor: | 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, Yang Hong, Collaborative Group the AME Thoracic Surgery |
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| Rok vydání: | 2020 |
| Předmět: |
Fibrin sealant
medicine.medical_specialty medicine.medical_treatment Fistula Esophageal cancer Clinical Trials Study Phases of clinical research McKeown esophagectomy Anastomosis Postoperative complications 03 medical and health sciences 0302 clinical medicine Interquartile range Clinical endpoint Anastomotic leakage Medicine business.industry Prevention Gastroenterology Perioperative medicine.disease Surgery Oncology Esophagectomy 030220 oncology & carcinogenesis 030211 gastroenterology & hepatology business |
| Zdroj: | World Journal of Gastrointestinal Oncology |
| ISSN: | 1948-5204 0352-9266 |
| DOI: | 10.4251/wjgo.v12.i6.651 |
| Popis: | Background Esophagectomy is a pivotal curative modality for localized esophageal or esophagogastric junction cancer (EC or EJC). Postoperative anastomotic leakage (AL) remains problematic. The use of fibrin sealant (FS) may improve the strength of esophageal anastomosis and reduce the incidence of AL. Aim To assess the efficacy and safety of applying FS to prevent AL in patients with EC or EJC. Methods In this single-arm, phase II trial (Clinicaltrial.gov identifier: NCT03529266), we recruited patients aged 18-80 years with resectable EC or EJC clinically staged as T1-4aN0-3M0. An open or minimally invasive McKeown esophagectomy was performed with a circular stapled anastomosis. After performing the anastomosis, 2.5 mL of porcine FS was applied circumferentially. The primary endpoint was the proportion of patients with AL within 3 mo. Results From June 4, 2018, to December 29, 2018, 57 patients were enrolled. At 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 fistula. The incidence of anastomotic stricture and other major postoperative complications was 1.8% and 17.5%, respectively. The 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 recorded. No deaths occurred within 90 d after surgery. Conclusion Perioperative sealing with porcine FS appears safe and may prevent AL after esophagectomy in patients with resectable EC or EJC. Further phase III studies are warranted. |
| Databáze: | OpenAIRE |
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