OBSiDiAN in a Stapled Circular Esophagogastric Anastomosis After Ivor Lewis Esophagectomy

Multicentre randomized controlled trial to evaluate the effectiveness of an autologous BioMatrix on a circular stapled esophagogastric anastomosis after Ivor Lewis esophagectomy.

Inclusion Criteria:preoperativelySubjects ≥ 18 years and ≤ 75 years who are willing to participate and provide written informed consent prior to any study-related procedures.Subjects with oesophageal carcinoma scheduled for elective minimally invasive or open Ivor Lewis esophagectomy Intra-operativelyintrathoracic circular stapled esophagogastric anastomosisExclusion Criteria:preoperativelyFemale patients who are pregnant or nursingParticipation in another study involving investigational drugs or devices.Use of Avastin within 30 days prior to surgeryASA IV (American Society of Anesthesiologists physical status classification system: patient with severe systemic disease that is a constant threat to life)Patients with other malignanciesPatients with previous oesophageal or gastric surgeryKnown hypersensitivity to batroxobin and tranexamic acid.Hemoglobin level < 8 g/dL Intra-operativelyIntra-operative findings that may preclude conduct of the study procedures, such as pleural metastasis, tumor invasion in other organs, …Anastomosis preformed differently than the standard of careExcessive bleeding (>500 ml) prior to anastomosis