OBSiDiAN in a Stapled Circular Esophagogastric Anastomosis After Ivor Lewis Esophagectomy
- Conditions
- Anastomotic Leak Esophagus
- Interventions
- Device: Obsidian
- Registration Number
- NCT05713955
- Lead Sponsor
- University Hospital, Ghent
- 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).
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 90
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description study group Obsidian 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 or other 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method mortality from surgery until 30 days post operative in hospital mortality
inflammation WBC from date of randomisation to postoperative day 5 post operative inflammation (WBC)
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 duration from surgery until removal of thoracic drain within the first week postoperative duration of thoracic drain
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 (ECCG type I, II and III)
stricture from surgery until 1 year post operative stricture of the esophagogastric anastomosis
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
thoracic drainage volume from surgery until removal of thoracic drain within the first week postoperative Volume 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
Trial Locations
- Locations (1)
University Hospital Ghent
🇧🇪Ghent, East-Flanders, Belgium