OBSiDiAN in a Stapled Circular Esophagogastric Anastomosis After Ivor Lewis Esophagectomy

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.

NCT Number	NCT05713955
Lead Sponsor	University Hospital, Ghent Collaborators: Vivostat
Conditions	Anastomotic Leak Esophagus
Enrollment	90 participants
Start Date	2025-04-01
Primary Completion	2028-04-01 (estimated)
Study Completion	2029-04-01 (estimated)
Updated on ClinicalTrials.gov	2025-04-02