Anastomotic Leak Esophagus
Conditions
Keywords
anastomotic leakage, esophageal cancer surgery, autologous biomatrix
Brief summary
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.
Detailed description
STUDY PRODUCT Autologous BioMatrix: Obsidian (medical device class III) STUDY POPULATION Subjects ≥ 18 years and ≤ 75 years of age scheduled for elective Ivor Lewis esophagectomy for esophageal cancer with a circular stapled intrathoracic esophagogastric anastomosis. SAMPLE SIZE A total of 90 patients will be included in the study. ENROLEMENT PERIOD Based on an annual number of 70-80 esophagectomies in University Hospital Ghent, we predict an enrolment period of 3 years. STUDY DURATON Considering a 3 years enrolment period and a 1 year follow up we predict a study duration of 4 years. PRIMAIRY ANALYSIS • Anastomotic leak within 30 days post operatively. Anastomotic leak type I, II and III is defined according to the Esophagectomy Complications Consensus Group (ECCG).
Interventions
DEVICEObsidian
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
Sponsors
Vivostat
University Hospital, Ghent
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anastomotic leak | Absence of anastomotic leak within 30 days post operatively | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| inflammation CRP | from date of randomisation to postoperative day 5 | post operative inflammation (CRP) |
| ICU stay | from surgery until discharge or until the date of death from any cause, whichever came first, assessed up to 3 months | length of ICU stay |
| hospital stay | from surgery until discharge or until the date of death from any cause, whichever came first, assessed up to 3 months | total hospital stay |
| mortality | from surgery until 30 days post operative | in hospital mortality |
| sepsis | from surgery until 30 day post operative | in hospital sepsis |
| inflammation WBC | from date of randomisation to postoperative day 5 | post operative inflammation (WBC) |
| late anastomotic leakage | from surgery until 90 days post operative | late anastomotic leakage (ECCG type I, II and III) |
| stricture | from surgery until 1 year post operative | stricture of the esophagogastric anastomosis |
| thoracic drainage volume | from surgery until removal of thoracic drain within the first week postoperative | Volume of thoracic drain |
| thoracic drainage duration | from surgery until removal of thoracic drain within the first week postoperative | duration of thoracic drain |
| intra-operative checklist | peroperative | * Hb \> 8 g/dL * No tension on the anastomosis * No torsion on the anastomosis * Complete visibility of the anastomosis * Dry operation area * Application on the gastric stump * Application area of 2 cm proximal and distal of the anastomosis * Application completely covering the anastomosis * Visible white layer of fibrin sealant * Dry for 30 seconds |
| pneumonia | from surgery until 30 day post operative | in hospital pneumonia |
Countries
Belgium
Contacts
Primary ContactHanne Vanommeslaeghe
Outcome results
None listed