Obesity is an epidemic in the US. With progression of obesity, Nonalcoholic steatohepatitis (NASH) has been a growing public health issue. Presently there is no cure for NASH.Prevention of progression of fibrosis in NASH is crucial, as they are at a high risk for cirrhosis and may need liver transplant.
Recent studies have shown that blocking blood vessels to a particular portion of the stomach (bariatric or left gastric artery embolization) can temporarily decrease levels of the appetite inducing hormone ghrelin, and result in weight loss.The purpose of this study is to determine if Left gastric artery embolization (LGAE) in patients with obesity and NASH leads to clinically significant weight loss with improvement of NASH.
Male or Female, aged 22 years or older.
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
BMI >35 kg/m2
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."
Pregnancy
Active substance abuse
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.]
Significant alcohol consumption ( >20 g/day in women, >30 g/day in men)
Single group
Embospheres Microspheres
DeviceVia a radial artery in the wrist or the femoral artery in the groin, arterial access will be obtained.Under live X-ray monitoring and using contrast, a catheter will be advanced into the artery of the stomach (left gastric artery). A CT scan will be performed on the X ray table to confirm the placement of catheter. Once this is confirmed small micro spherical particles (Embopheres Microspheres) will be injected though the catheter to occlude the artery and cut off blood supply to the stomach. Once the procedure is complete, in case of wrist access compression will be achieved with a band; in case of groin access a closure device will be used to plug the site of entry.
Weight
Total body Weight loss \> 10 % in 12 months
Clinical parameter- Abdominal circumference
Improvement in abdominal circumference measured in centimeters (cm)
Clinical parameter-Blood pressure
Improvement in blood pressure measured in mmHg
Laboratory parameter-Ghrelin and other serum obesity hormones(Leptin, GLP-1, PYY)
Reduction in serum Ghrelin and other serum obesity hormones(Leptin, GLP-1, PYY) measured in pg/mL
Laboratory parameter-serum glucose
Reduction in serum glucose levels measured as mg/dL
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Keith Pereira, MD:
Lead sponsor
St. Louis University
Sponsor institution
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