STUDY PRODUCT Autologous BioMatrix: Obsidian (medical device class III)~STUDY POPULATION Subjects ≥ 18 years and ≤ 75 years of age scheduled for elective Ivor Lewis esophagectomy for oesophageal cancer with a circular stapled intrathoracic esophagogastric anastomosis.~SAMPLE SIZE A total of 600 patients will be included in the study. 300 patients in each study arm.~ENROLEMENT PERIOD Based on an annual number of 70-80 esophagectomies in this centre, University Hospital Ghent, with inclusion of patients in other European high volume centers, we predict an enrolment period of 4 years.~PRIMARY ENDPOINT Anastomotic leak type I, II and III within 30 days post operatively. Anastomotic leak is defined according to the Esophagectomy Complications Consensus Group (ECCG).
Multicentre randomized controlled trial to evaluate the effectiveness of an autologous BioMatrix on a circular stapled esophagogastric anastomosis after Ivor Lewis esophagectomy.