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

Abstract

PurposeAnastomotic 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 AL. This study aims to evaluate the safety and effectiveness of FS in preventing AL in patients undergoing McKeown esophagectomy.MethodsIn 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 180. Patients 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 alone. The primary endpoint was the incidence of cervical AL within the first 3 months postoperatively.ResultFrom February 2019 to November 2021, 180 patients were recruited, with 89 in the FS group and 91 in the control group. There 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 postoperatively.ConclusionThe 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 enrollment.Trial registrationThis trial was registered at ClinicalTrials.gov (NCT03847857) on February 19th, 2019.