Bariatric Embolization Before Sleeve Gastrectomy for Super Obese Patients (EMBOSLEEVE)
Sleeve Gastrectomy, Morbid Obesity, Bariatric Surgery
About this trial
This is an interventional other trial for Sleeve Gastrectomy focused on measuring bariatric embolization, sleeve gastrectomy, super obese, left gastric artery, Morbid Obesity, bariatric surgery
Eligibility Criteria
Inclusion Criteria: Willing, able and mentally competent to provide written informed consent. Body mass index (BMI) >50kg/m². 3 risk factors (De Maria et al) among: hypertension, male gender, age>45, risk of pulmonary embolism Vascular anatomy (including celiac, hepatic, and gastric arteries) that in the opinion of the interventional radiologist amenable to Bariatric Embolization, as assessed on 3D CT angiography. Adequate hematological, hepatic and renal function as follows: Hematological Neutrophils > 1.5 x 109/L Platelets > 100 x 109/L INR <1.5 Hepatic Bilirubin ≤ 2.0 mg/dL Albumin ≥ 2.5 g/L Renal Estimated GFR > 60ml/min.1.73m2 Aged 18 years or older. Patient who is going to be operated by sleeve gastrectomy Exclusion Criteria: Prior history of gastric pancreatic, hepatic, and/or splenic surgery Prior radiation to the upper abdomen Prior embolization to the stomach, spleen or liver Portal venous hypertension Prior or current history of peptic ulcer disease Significant risk factors for peptic ulcer disease including daily NSAID use and smoking. Active H. Pylori infection Weight greater than 240 kg Known aortic pathology such as aneurysm or dissection renal insufficiency as evidenced by an estimated glomerular filtration rate of < 60 milliliters per minute Major comorbidity such as cancer, significant cardiovascular disease, diabetes, or peripheral arterial disease. Pregnancy ASA Class 4 or 5 (very high risk surgical candidates: class 4= incapacitating disease that is a constant threat to life) at the time of screening for enrollment into the study will be excluded from participation. This exclusion criterion exists because of the possibility that surgical intervention will be needed if the study intervention subsequently leads to severe adverse effects. History of Inflammatory Bowel Disease Cirrhosis Known history of allergy to iodinated contrast media Contraindications to use Embosphere (ex:known allergy to gelatin ..)
Sites / Locations
- CHU Amiens-PicardieRecruiting