Bariatric Embolization of Arteries for the Treatment of Nonalcoholic Steatohepatitis
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|ClinicalTrials.gov Identifier: NCT02933554|
Recruitment Status : Not yet recruiting
First Posted : October 14, 2016
Last Update Posted : August 17, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Obesity Weight Loss Body Weight Nonalcoholic Steatohepatitis Nonalcoholic Fatty Liver Disease NAFLD||Device: Embospheres Microspheres||Not Applicable|
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, hyperlipidemia) has been established as risk factor for primary nonalcoholic fatty liver disease (NAFLD) .In the US, recent estimates suggest that NAFLD affects 30% of the general population, 90% of the morbidly obese . NAFLD can progress to nonalcoholic steatohepatitis (NASH) in up to 25% . Of patients with NASH progression of fibrosis is seen in 26-37% and progressing to cirrhosis in 9-25 % . NASH cirrhosis can result in liver failure, portal hypertension, and hepatocellular carcinoma(HCC) .
Current options in management of NASH: The goal of managing NASH is to eliminate risk factors and preventing fibrosis by treating metabolic syndrome, primarily obesity . Although dietary modification and exercise can achieve weight loss, this is difficult to sustain . Very few effective medical therapies are available, and are associated with adverse effects. Although weight loss after bariatric surgery has demonstrated histological improvement in NASH, a recent Cochrane review concluded that there is insufficient data to determine if bariatric surgery is an effective treatment. Also high mortality rates are seen post-bariatric surgery.
Thus a safe and effective minimally invasive option is needed. Based on currently available data, Left gastric artery embolization (LGAE) appears effective in inducing weight loss of about 10.5% in 3-6 months, with a high safety profile. In patients with NAFLD, a 3-5% weight loss is thought to improve steatosis, 7- 10% may be needed to improve necroinflammation. Thus, LGAE has the potential to reverse the histology of NASH to prevent progression to cirrhosis, HCC and its sequale.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Estimated Study Start Date :||January 2019|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
Experimental: NASH- Left gastric artery embolization
Embospheres Microspheres as artificial embolic agent for left gastric artery embolization
Device: Embospheres 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.
Other Name: Bariatric embolization
- Weight [ Time Frame: 12 months ]Total body Weight loss > 10 % in 12 months
- Clinical parameter- Abdominal circumference [ Time Frame: 12 months ]Improvement in abdominal circumference measured in centimeters (cm)
- Clinical parameter-Blood pressure [ Time Frame: 12 months ]Improvement in blood pressure measured in mmHg
- Laboratory parameter-Ghrelin and other serum obesity hormones(Leptin, GLP-1, PYY) [ Time Frame: 12 months ]Reduction in serum Ghrelin and other serum obesity hormones(Leptin, GLP-1, PYY) measured in pg/mL
- Laboratory parameter-serum glucose [ Time Frame: 12 months ]Reduction in serum glucose levels measured as mg/dL
- Laboratory parameters- HbA1c [ Time Frame: 12 months ]Reduction in HbA1c measures as percentage(%)
- Laboratory parameters-Lipid profile [ Time Frame: 12 months ]Improvement in lipid profile measured as mg/dL
- Number of patients with clincal adverse events [ Time Frame: 12 months ]
- Results from endoscopy [ Time Frame: 12 months ]Photos and clinical reports analyzed
- Change in inflammation, fibrosis, steatosis in liver histology [ Time Frame: 12 months ]Change in liver histology between baseline and 12 months in liver histology
- NAFLD activity score [ Time Frame: 12 months ]Change in NAFLD Activity score (Kleiner) between baseline and 12 months in liver histology
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02933554
|Contact: Keith Pereira, MDfirstname.lastname@example.org|
|United States, Missouri|
|Saint Louis University|
|Saint Louis, Missouri, United States, 63110|
|Principal Investigator:||Keith Pereira, MD||Assistant professor of radiology-Interventional radiology|
|Principal Investigator:||Brent Neuschwander-Tetri, MD||Professor of medicine- gastroenterology|
|Principal Investigator:||Kirubahara Vaheesan, MD||Assistant professor of radiology- Interventional radiology|