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.
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).
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)
Single group
Obsidian
DeviceTo create OBSiDiAN BioMatrix, 120 ml of the the patient's blood is added to the processing unit. The Vivostat® processor unit heats, separates, centrifugates to get the plasma. Batroxobin is added. After again processing, the result is an OBSiDian syringe filled with BioMatrix Obsidian®ASG. This will be applied on the anastomosis
Anastomotic leak
Anastomotic leak defined according to the ECCG guidelines type I: local defect requiring no change in therapy or treated medicallly or with dietary modifications type II: localized defect requiring interventional but not surgical therapy, for example, interventional radiology drain, stent or bedside opening and packing or incision type III: localized defect requiring surgical therapy
mortality
in hospital mortality
sepsis
in hospital sepsis
pneumonia
in hospital pneumonia
late anastomotic leakage
late anastomotic leakage (ECCG type I, II and III)
Click on the lead sponsor to view all of their trials.
University Hospital, Ghent
Lead sponsor
Vivostat
Collaborator
