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Trial record 33 of 277 for:    Non-alcoholic Steatohepatitis | United States

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 : May 8, 2019
Sponsor:
Information provided by (Responsible Party):
Keith Pereira, MD:, St. Louis University

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.


Condition or disease Intervention/treatment Phase
Obesity Weight Loss Body Weight Nonalcoholic Steatohepatitis Nonalcoholic Fatty Liver Disease NAFLD Device: Embospheres Microspheres Not Applicable

Detailed 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, 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 [10]. 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 : December 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Weight [ Time Frame: 12 months ]
    Total body Weight loss > 10 % in 12 months


Secondary Outcome Measures :
  1. Clinical parameter- Abdominal circumference [ Time Frame: 12 months ]
    Improvement in abdominal circumference measured in centimeters (cm)

  2. Clinical parameter-Blood pressure [ Time Frame: 12 months ]
    Improvement in blood pressure measured in mmHg

  3. 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

  4. Laboratory parameter-serum glucose [ Time Frame: 12 months ]
    Reduction in serum glucose levels measured as mg/dL

  5. Laboratory parameters- HbA1c [ Time Frame: 12 months ]
    Reduction in HbA1c measures as percentage(%)

  6. Laboratory parameters-Lipid profile [ Time Frame: 12 months ]
    Improvement in lipid profile measured as mg/dL

  7. Number of patients with clincal adverse events [ Time Frame: 12 months ]
  8. Results from endoscopy [ Time Frame: 12 months ]
    Photos and clinical reports analyzed

  9. Change in inflammation, fibrosis, steatosis in liver histology [ Time Frame: 12 months ]
    Change in liver histology between baseline and 12 months in liver histology

  10. NAFLD activity score [ Time Frame: 12 months ]
    Change in NAFLD Activity score (Kleiner) between baseline and 12 months in liver histology



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Keith Pereira, MD 314-268-5558 keith.pereira@health.slu.edu

Locations
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United States, Missouri
Saint Louis University
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Keith Pereira, MD:
Investigators
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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

Publications of Results:

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Responsible Party: Keith Pereira, MD:, MD, St. Louis University
ClinicalTrials.gov Identifier: NCT02933554     History of Changes
Other Study ID Numbers: 27420-NASH
First Posted: October 14, 2016    Key Record Dates
Last Update Posted: May 8, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Keith Pereira, MD:, St. Louis University:
bariatric surgery
minimally invasive
Embolization
NASH
ghrelin
gastric artery embolization

Additional relevant MeSH terms:
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Body Weight
Weight Loss
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Signs and Symptoms
Body Weight Changes
Digestive System Diseases