Bariatric Embolization of Arteries for the Treatment of Nonalcoholic Steatohepatitis

Exclusion Criteria

• •1. Pregnancy
• •2. Active substance abuse
• •3. Significant psychiatric problems, severe enough to cause suffering or a poor ability to function in life. Center for Epidemiological Studies Depression (CESD) score \> or = 16 without psychiatric evaluation. \[If Center for Epidemiological Studies Depression (CESD) score \> or =16 AND is in care of behavior health specialist who has indicated patient has adequate coping mechanisms to undergo procedure and does not foresee mental health as barrier to participation in study.\]
• •4. Significant alcohol consumption ( \>20 g/day in women, \>30 g/day in men)
• •5. Weight \> 400 lbs, BMI \> 50 kg/m2.
• •6. Contraindications to obtaining a liver biopsy
• •7. Subjects with pre-existing abdominal pain will be excluded (because of the potential confusion with pain related to the procedure).
• •8. Subjects who are intolerant to PPIs
• •9. Subjects requiring any anticoagulant medications should be excluded if radial access cannot be obtained.
• •10. Subjects with platelets \<35 x 109/L and INR \> 2.0
• •11. Subjects who are taking aspirin/ NSAIDs and in whom these medications are unable to be withdrawn from aspirin and NSAIDs for at least 3 days prior to the LGAE procedure and for 30 days following the LGAE procedure (because of the potential risks of gastric bleeding following the procedure).
• •13. Metastatic cancer
• •14. Evidence of decompensated liver disease (uncontrolled ascites, or uncontrolled spontaneous encephalopathy)
• •15. prior surgical weight loss procedures including gastroplasty, jejunoileal, or jejunocolic bypass, total parenteral nutrition within the past 6 months; Prior history of gastric pancreatic, hepatic, and/or splenic surgery
• •16. Prior embolization to the stomach, spleen or liver, unless the prior embolization was a transarterial chemoembolization (TACE) to the liver for HCC.
• •17. If review of available prior imaging studies (i.e CT, MRI, or US)shows potential anatomical variations, presence of severe atheromatous disease, large arteriovenous shunting of blood.
• •18. Abnormal Endoscopy - large sliding hiatal hernia or paraesophageal hernia, active peptic ulcer disease, active H. pylori infection
• •19. History of abnormal Nuclear Gastric Motility examination-defined as delayed emptying of gastric contents \> 90%, 60% and 10% at 1 hour, 2 hours, and 4 hours respectively.
• •20. ASA Class 4 or 5
• •21. Child Pugh classification C
• •22. Known aortic disease, such as dissection or aneurysm; peripheral arterial disease or other cardiovascular disease.
• •23. Type 2 diabetes on anti-diabetic medications that are known to cause hypoglycemia. e.g. sulphonylureas, meglitinides
• •24. Patients with a known other cause for their increased liver enzyme levels such as viral hepatitis (B or C), autoimmune/chronic immune hepatitis, primary biliary cholangitis, metabolic and genetic hemochromatosis, Wilson's disease, or alpha-1 antitrypsin deficiency
• •25. Patient taking hepatotoxic drugs. List of drugs causing steatohepatitis include but are not limited to: amiodarone, chemotherapy (5-fluorouracil, tamoxifen, irinotecan, cisplatin, and asparaginase), glucocorticoids, methotrexate, sulfonamides, antithyroid drugs, phenytoin, tetracyclines, isoniazid, salicylates, and valproic acid.
• •26. Contraindications to obtaining a liver biopsy (NASH cohort)
• •27. Patients taking other trial medications for NASH.