obsidian in a stapled circular esophagogastric anastomosis after ivor lewis esophagectomy

Conditions: Anastomotic Leak Esophagus

Summary: oesophagectomy is very invasive surgery. a leakage at the level of the connection between oesophagus and stomach made during surgery causes a lot more problems and can lead to death. studies show that the leakage rate sometimes goes up to 40 per cent. the chance of dying if you develop a leak after surgery is 15%, while the overall chance of dying during hospitalisation for this procedure is about 4%. we want to investigate whether the use of this new type of 'glue' (obsidian®) can reduce the number of leaks. we invite you to participate in a clinical trial with the aim of investigating whether obsidian® is safe and can reduce the number of leaks after oesophageal surgery in patients with oesophageal cancer. we want to apply a new type of 'glue', obsidian®, at the level of the new connection between oesophagus and stomach.

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 esophageal cancer with a circular stapled intrathoracic esophagogastric anastomosis. sample size a total of 90 patients will be included in the study. enrolement period based on an annual number of 70-80 esophagectomies in university hospital ghent, we predict an enrolment period of 3 years. study duraton considering a 3 years enrolment period and a 1 year follow up we predict a study duration of 4 years. primairy analysis • anastomotic leak within 30 days post operatively. anastomotic leak type i, ii and iii is defined according to the esophagectomy complications consensus group (eccg).

Eligibility criteria:
1. inclusion criteria preoperatively * subjects ≥ 18 years and ≤ 75 years who are willing to participate and provide written informed consent prior to any study-related procedures. * subjects with esophageal carcinoma (distal until siewert ii) scheduled for elective minimally invasive ivor lewis esophagectomy (ct1-4a,n0-3,m0). intra-operatively - intrathoracic circular stapled esophagogastric anastomosis 2. exclusion criteria preoperatively * female patients who are pregnant or nursing * participation in another study involving investigational drugs or devices. * use of avastin within 30 days prior to surgery * asa iv (patient with severe systemic disease that is a constant threat to life) * patients with other malignancies * patients with previous esophageal or gastric surgery * known hypersensitivity to batroxobin and tranexamic acid. * hb level \< 8 g/dl * patients on medicine containing acetylsalicylic acid not able to stop using the medicine for medical reasons minimum 3 days before taking the blood sampling. * patients on clopidogrel not able to stop clopidogrel for medical reasons 7 days before blood sampling * patients on other platelet aggregation inhibitor therapies not able to stop using the platelet aggregation inhibitor therapies for 3 days before taking the blood sample. intra-operatively * intra-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 care * excessive bleeding (\>500 ml) prior to anastomosis

Keywords: anastomotic leakage esophageal cancer surgery autologous biomatrix