NCT05713955RecruitingPhase 2
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.
Source: ClinicalTrials.gov · Last updated 21 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 8 Nov 2021
- Start date
- 1 Jun 2025
- Primary completion date
- 1 Jan 2027
- Lead sponsor
- University Hospital, Ghent
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT05713955
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 90
- From 1 Jun 2025 to the primary completion date, 1 Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Ghent Coordinator of this site? Confirm its status | Ghent | Belgium | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.