OBSiDiAN in a Stapled Circular Esophagogastric Anastomosis After Ivor Lewis Esophagectomy
Study Details
Study Description
Brief Summary
Multicentre randomized controlled trial to evaluate the effectiveness of an autologous BioMatrix on a circular stapled esophagogastric anastomosis after Ivor Lewis esophagectomy.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 oesophageal cancer with a circular stapled intrathoracic esophagogastric anastomosis.
SAMPLE SIZE A total of 250 patients will be included in the study. 125 patients in each study arm.
ENROLEMENT PERIOD Based on an annual number of 70-80 esophagectomies in this centre, University Hospital Ghent, with inclusion of patients in a German, three or two Austrian and a Dutch centre, we predict an enrolment period of 2 years.
PRIMARY ENDPOINT Absence of anastomotic leak within 30 days post operatively. Anastomotic leak is defined according to the Esophagectomy Complications Consensus Group (ECCG) type III.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: study group For the study group, a unit of autologous BioMatrix OBSiDiAN will be produced. Blood sample (120ml) will be taken after randomization at the ending of the abdominal phase of the surgery. The surgeon will create an esophagogastric anastomosis, after ruling out tension or torsion. Around 1-2ml of autologous BioMatrix OBSiDiAN will be applied on the distal/or proximal resection stump before the stapled anastomose will be created. After firing the standard circular device and creation of a functional anastomosis, a further 2.5-3ml OBSiDiAN must be applied circumferentially on the outside on the anastomosis. Once application is completed, a 30 seconds waiting period is required before putting the esophagus back into the surgical field (study specific). A methylene blue leakage test is performed (standard of care). If there is a leak, the anastomosis will be corrected or the completed procedure has to be done again. |
Device: Obsidian
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
|
| No Intervention: standard group The surgeon will create an esophagogastric anastomosis, after ruling out tension or torsion. A methylene blue leakage test is performed (standard of care). If there is a leak, the anastomosis will be corrected. |
Outcome Measures
Primary Outcome Measures
- Anastomotic leak [Absence of anastomotic leak within 30 days post operatively]
Anastomotic leak defined according to the ECCG guidelines11 type III: localized defect requiring surgical therapy
Secondary Outcome Measures
- mortality [from surgery until 30 days post operative]
in hospital mortality
- sepsis [from surgery until 30 day post operative]
in hospital sepsis
- pneumonia [from surgery until 30 day post operative]
in hospital pneumonia
- late anastomotic leakage [from surgery until 90 days post operative]
late anastomotic leakage
- stricture [from surgery until 1 year post operative]
stricture of the esophagogastric anastomosis
- inflammation [from date of randomisation to postoperative day 5]
post operative inflammation (WBC)
- inflammation [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
- 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
Eligibility Criteria
Criteria
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.
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Subjects with oesophageal carcinoma scheduled for elective minimally invasive or open Ivor Lewis esophagectomy Intra-operatively
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intrathoracic circular stapled esophagogastric anastomosis
Exclusion Criteria:
preoperatively
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Female patients who are pregnant or nursing
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Participation in another study involving investigational drugs or devices.
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Use of Avastin within 30 days prior to surgery
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ASA IV (American Society of Anesthesiologists physical status classification system: patient with severe systemic disease that is a constant threat to life)
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Patients with other malignancies
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Patients with previous oesophageal or gastric surgery
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Known hypersensitivity to batroxobin and tranexamic acid.
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Hemoglobin level < 8 g/dL Intra-operatively
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Intra-operative findings that may preclude conduct of the study procedures, such as pleural metastasis, tumor invasion in other organs, …
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Anastomosis preformed differently than the standard of care
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Excessive bleeding (>500 ml) prior to anastomosis
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University Hospital, Ghent
Investigators
- Principal Investigator: Piet Pattyn, UZ Gent
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BC-09974