[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"anastomotic-leak-esophagus\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:anastomotic-leak-esophagus":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100494113","phase-2-obsidian-in-a-stapled-circular-esophagogastric-anastomosis-after-ivor-lewis-esophagectomy-100494113",false,"NCT05713955","OBSiDiAN in a Stapled Circular Esophagogastric Anastomosis After Ivor Lewis Esophagectomy","Evaluation of Effectiveness and Safety of Autologous BioMatrix OBSiDiAN to Enhance a Stapled Circular Esophagogastric Anastomosis After Ivor Lewis Esophagectomy, a Phase II Study.","Obsidian ph II","1. Inclusion criteria Preoperatively\n\n   * Subjects ≥ 18 years and ≤ 75 years who are willing to participate and provide written informed consent prior to any study-related procedures.\n   * Subjects with esophageal carcinoma (distal until Siewert II) scheduled for elective minimally invasive Ivor Lewis esophagectomy (cT1-4a,N0-3,M0).\n\n   Intra-operatively\n\n   \\- Intrathoracic circular stapled esophagogastric anastomosis\n2. Exclusion criteria preoperatively\n\n   * Female patients who are pregnant or nursing\n   * Participation in another study involving investigational drugs or devices.\n   * Use of Avastin within 30 days prior to surgery\n   * ASA IV (patient with severe systemic disease that is a constant threat to life)\n   * Patients with other malignancies\n   * Patients with previous esophageal or gastric surgery\n   * Known hypersensitivity to batroxobin and tranexamic acid.\n   * HB level \\\u003C 8 g\u002FdL\n   * Patients on medicine containing acetylsalicylic acid not able to stop using the medicine for medical reasons minimum 3 days before taking the blood sampling.\n   * Patients on clopidogrel not able to stop clopidogrel for medical reasons 7 days before blood sampling\n   * 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.\n\nIntra-operatively\n\n* Intra-operative findings that may preclude conduct of the study procedures, such as pleural metastasis, tumor invasion in other organs, …\n* Anastomosis preformed differently than the standard of care\n* Excessive bleeding (\\>500 ml) prior to anastomosis","ALL","18 Years","75 Years",{"count":21,"type":22},90,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","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.",[28],"Anastomotic Leak Esophagus",[30,31,32],"anastomotic leakage","esophageal cancer surgery","autologous biomatrix","RECRUITING","2026-09-16",{"date":36,"type":37},"2026-09-21","ACTUAL",{"date":39,"type":37},"2025-06-01",{"date":41,"type":22},"2027-01-01",{"name":43,"class":44},"University Hospital, Ghent","OTHER",2]