Bariatric Embolization of Arteries for the Treatment of Nonalcoholic Steatohepatitis

Launched by KEITH PEREIRA, MD: · Oct 12, 2016

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called Left Gastric Artery Embolization (LGAE) for people who are struggling with obesity and a liver condition known as Nonalcoholic Steatohepatitis (NASH). NASH is a serious liver disease that can lead to cirrhosis and possibly the need for a liver transplant. The trial aims to see if this procedure can help participants lose weight and improve their liver health by blocking blood flow to part of the stomach, which may reduce hunger.

To be eligible for the trial, participants must be at least 22 years old, have a body mass index (BMI) of over 35, and have been diagnosed with NASH within the last year. They should also be willing to follow the study procedures. Participants can expect to undergo the LGAE procedure and will be monitored for changes in their weight and liver condition. This trial is not yet recruiting, but it represents an important step in finding new ways to treat obesity and liver diseases.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or Female, aged 22 years or older.
• • 2. Willing, able and mentally competent to provide written informed consent and willing to comply with all study procedures and be available for the duration of the study
• • 3. BMI \>35 kg/m2
• 4. Adequate hematological, hepatic and renal function as follows:
• • 1. Hematological: Hematological: If the bariatric embolization procedure is being performed by femoral access: platelets \> 50 x 109/L, INR \<1.5. If the bariatric embolization procedure is being performed by radial access: platelets \>35 x 109/L and INR \<1.5 OR platelets \>50 x 109/L and INR between 1.5 and 2."
• • 2. Hepatic : Total bilirubin \<3 mg/dL
• • 3. Renal: Estimated GFR \> 60ml/min.1.73m2
• • 5. 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.
• • 6. Elevated alanine or aspartate aminotransferase values (ALT \>41 or AST\>34 U/L).
• • 7. Liver biopsy showing evidence of NASH in the past 12 months.
• • 8. No evidence of another form of liver disease.
• • 9. Patients diagnosed with NASH and have evidence of failing other methods of weight loss through diet, exercise and behavior modification.
• 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).
• • 12. Presence of systemic illness or other medical conditions relevant to survival .(Note that in the HCC pre liver transplant cohort, the presence of HCC will not be considered an exclusion criteria)
• • 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.