RECRUITING Phase 2 ClinicalTrials.gov

OBSiDiAN in a Stapled Circular Esophagogastric Anastomosis After Ivor Lewis Esophagectomy

Sponsor: University Hospital, Ghent • ClinicalTrials.gov ID: NCT05713955

Registry updated: 2026-09-21

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Description

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.

Interventions

Obsidian (Device)
To 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

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

Conditions

Anastomotic Leak Esophagus

Locations

University Hospital Ghent — Ghent, East-Flanders, Belgium
University Hospital Ghent — Ghent, East-Flanders, Belgium

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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