A Single Center, Non-randomized Study to Evaluate the Safety and Efficacy of Left Gastric Artery Embolization, to Promote Short-term Weight Loss in Obese Patients With Nonalcoholic Steatohepatitis (NASH) and Thereby Improve NASH
Keith Pereira, MD:
Summary
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.
Description
Obesity:In adults, obesity is defined as a BMI of greater than 30 kg/m2. It is estimated that, by the year 2030, 38% of the world's adult population will be overweight and another 20% obese.An expert panel convened by the NIH stated that for the first time in history, the steadily improving worldwide life expectancy could level off or even decline, as the result of increasing obesity. NAFLD and NASH: The Problem: Obesity is a chronic disease that is strongly associated with a number of diseases with an increase in mortality and morbidity. Metabolic syndrome (obesity, diabetes mellitus, hyper…
Eligibility
- Age range
- 22–65 years
- Sex
- All
- Healthy volunteers
- Yes
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 \>5…
Interventions
- DeviceEmbospheres Microspheres
Via 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.
Location
- Saint Louis UniversitySt Louis, Missouri