Bariatric Embolization of Arteries for the Treatment of Nonalcoholic Steatohepatitis

NCT02933554 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: 27420-NASH
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity; Weight Loss; Body Weight; Nonalcoholic Steatohepatitis; Nonalcoholic Fatty Liver Disease; NAFLD

Keywords

bariatric surgery; minimally invasive; Embolization; NASH; ghrelin; gastric artery embolization

Outcome Measures

Primary Outcomes (1)

• Weight

  Total body Weight loss \> 10 % in 12 months

  12 months

Secondary Outcomes (10)

• Clinical parameter- Abdominal circumference

  12 months

• Clinical parameter-Blood pressure

  12 months

• Laboratory parameter-Ghrelin and other serum obesity hormones(Leptin, GLP-1, PYY)

  12 months

• Laboratory parameter-serum glucose

  12 months

• Laboratory parameters- HbA1c

  12 months

Study Arms (1)

NASH- Left gastric artery embolization

EXPERIMENTAL

Embospheres Microspheres as artificial embolic agent for left gastric artery embolization

Device: Embospheres Microspheres

Interventions

Embospheres Microspheres DEVICE

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.

Also known as: Bariatric embolization

NASH- Left gastric artery embolization

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Adequate hematological, hepatic and renal function as follows:
• 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."
• Hepatic : Total bilirubin \<3 mg/dL
• Renal: Estimated GFR \> 60ml/min.1.73m2
• 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.
• Elevated alanine or aspartate aminotransferase values (ALT \>41 or AST\>34 U/L).
• Liver biopsy showing evidence of NASH in the past 12 months.
• No evidence of another form of liver disease.
• Patients diagnosed with NASH and have evidence of failing other methods of weight loss through diet, exercise and behavior modification.

You may not qualify if:

• 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)
• Weight \> 400 lbs, BMI \> 50 kg/m2.
• Contraindications to obtaining a liver biopsy
• Subjects with pre-existing abdominal pain will be excluded (because of the potential confusion with pain related to the procedure).
• Subjects who are intolerant to PPIs
• Subjects requiring any anticoagulant medications should be excluded if radial access cannot be obtained.
• Subjects with platelets \<35 x 109/L and INR \> 2.0
• 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).
• Metastatic cancer
• Evidence of decompensated liver disease (uncontrolled ascites, or uncontrolled spontaneous encephalopathy)
• 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
• Prior embolization to the stomach, spleen or liver, unless the prior embolization was a transarterial chemoembolization (TACE) to the liver for HCC.

Sponsors & Collaborators

• Keith Pereira, MD: lead

Study Sites (1)

Saint Louis University

St Louis, Missouri, 63110, United States

Location

Related Publications (11)

• Chalasani N, Younossi Z, Lavine JE, Diehl AM, Brunt EM, Cusi K, Charlton M, Sanyal AJ. The diagnosis and management of non-alcoholic fatty liver disease: practice Guideline by the American Association for the Study of Liver Diseases, American College of Gastroenterology, and the American Gastroenterological Association. Hepatology. 2012 Jun;55(6):2005-23. doi: 10.1002/hep.25762. No abstract available.

  PMID: 22488764 RESULT

• Caldwell S, Argo C. The natural history of non-alcoholic fatty liver disease. Dig Dis. 2010;28(1):162-8. doi: 10.1159/000282081. Epub 2010 May 7.

  PMID: 20460906 RESULT

• Dyson JK, Anstee QM, McPherson S. Non-alcoholic fatty liver disease: a practical approach to treatment. Frontline Gastroenterol. 2014 Oct;5(4):277-286. doi: 10.1136/flgastro-2013-100404. Epub 2014 Jan 22.

  PMID: 25285192 RESULT

• Arepally A, Barnett BP, Montgomery E, Patel TH. Catheter-directed gastric artery chemical embolization for modulation of systemic ghrelin levels in a porcine model: initial experience. Radiology. 2007 Jul;244(1):138-43. doi: 10.1148/radiol.2441060790.

  PMID: 17581899 RESULT

• Arepally A, Barnett BP, Patel TH, Howland V, Boston RC, Kraitchman DL, Malayeri AA. Catheter-directed gastric artery chemical embolization suppresses systemic ghrelin levels in porcine model. Radiology. 2008 Oct;249(1):127-33. doi: 10.1148/radiol.2491071232.

  PMID: 18796671 RESULT

• Bawudun D, Xing Y, Liu WY, Huang YJ, Ren WX, Ma M, Xu XD, Teng GJ. Ghrelin suppression and fat loss after left gastric artery embolization in canine model. Cardiovasc Intervent Radiol. 2012 Dec;35(6):1460-6. doi: 10.1007/s00270-012-0362-8. Epub 2012 Feb 25.

  PMID: 22367009 RESULT

• Paxton BE, Alley CL, Crow JH, Burchette J, Weiss CR, Kraitchman DL, Arepally A, Kim CY. Histopathologic and immunohistochemical sequelae of bariatric embolization in a porcine model. J Vasc Interv Radiol. 2014 Mar;25(3):455-61. doi: 10.1016/j.jvir.2013.09.016. Epub 2014 Jan 21.

  PMID: 24462005 RESULT

• Kipshidze N, Archvadze A, Bertog S, Leon MB, Sievert H. Endovascular Bariatrics: First in Humans Study of Gastric Artery Embolization for Weight Loss. JACC Cardiovasc Interv. 2015 Oct;8(12):1641-4. doi: 10.1016/j.jcin.2015.07.016. No abstract available.

  PMID: 26493259 RESULT

• Syed MI, Morar K, Shaikh A, Craig P, Khan O, Patel S, Khabiri H. Gastric Artery Embolization Trial for the Lessening of Appetite Nonsurgically (GET LEAN): Six-Month Preliminary Data. J Vasc Interv Radiol. 2016 Oct;27(10):1502-8. doi: 10.1016/j.jvir.2016.07.010. Epub 2016 Aug 24.

  PMID: 27567998 RESULT

• Gunn AJ, Oklu R. A preliminary observation of weight loss following left gastric artery embolization in humans. J Obes. 2014;2014:185349. doi: 10.1155/2014/185349. Epub 2014 Sep 30.

  PMID: 25349724 RESULT

• Salsamendi J, Pereira K, Kang K, Fan J. Minimally invasive percutaneous endovascular therapies in the management of complications of non-alcoholic fatty liver disease (NAFLD): A case report. J Radiol Case Rep. 2015 Sep 30;9(9):36-43. doi: 10.3941/jrcr.v9i9.2557. eCollection 2015 Sep.

  PMID: 26629307 RESULT

MeSH Terms

Conditions

Obesity; Weight Loss; Body Weight; Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Keith Pereira, MD

CONTACT

314-268-5558; keith.pereira@health.slu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 11, 2016
• First Posted: October 14, 2016
• Study Start: December 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)