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Endoscopic Ultrasound(EUS)-Guided TRUCUT Biopsy (EUS-TCB) of Suspected Nonalcoholic Fatty Liver Disease(NAFLD.) (NAFLD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00586313
Recruitment Status : Completed
First Posted : January 4, 2008
Results First Posted : November 30, 2015
Last Update Posted : October 17, 2016
Information provided by (Responsible Party):
Indiana University

Brief Summary:
Endoscopic Ultrasound involves the placement of a small flexible camera through the mouth and into the stomach to image various parts of the body. A small piece of tissue called a biopsy, of your liver nay be obtained by this method. the tissue (biopsy) would be obtained by inserting a small needle through the lining of the stomach into the liver. Consideration for this biopsy is because there may be extra fat stored within the liver. In some people who drink too much alcohol, extra fat may be stored in the liver, however, in some people who don't drink too much alcohol, this may also occur and is called :non-alcoholic fatty liver disease or NAFLD. Over time, this extra fat may lead to liver irritation and scar tissue called cirrhosis. If NAFLD is detected early enough, then treatment with medications, losing weight, or dietary changes may help avoid cirrhosis. the purpose of this study is to learn about whether doctors can obtain the biopsy from the liver by a new method. The biopsy of the liver allows the doctors to look for any signs of scar tissue or inflammation from any cause.

Condition or disease Intervention/treatment Phase
Non-alcoholic Fatty Liver Disease Nonalcoholic Steatohepatitis Device: Tru-cut biopsy Procedure: Tru-cut Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Endoscopic Ultrasound(EUS)-Guided TRUCUT Biopsy (EUS-TCB) of Suspected Nonalcoholic Fatty Liver Disease(NAFLD.)
Study Start Date : January 2007
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Arm Intervention/treatment
Experimental: a1: Tru-Cut biopsy for liver
Tru-Cut Biospy.
Device: Tru-cut biopsy
Tru-cut biopsy may be an alternative to percutaneous and transjugular liver biopsy.
Other Name: Wilson-Cook 19 Gauge Quick-Core EUS Biopsy Needle.

Procedure: Tru-cut
Tru-cut may be an alternative to percutaneous and transjugular liver biopsy.

Primary Outcome Measures :
  1. Median Total Specimen Length [ Time Frame: 24 months ]
    Median Total Specimen Length grouped for indication for liver biopsy: Suspected NAFLD, Intrahepatic Cholestasis, Exclusion of Cirrhosis, Increased Liver Function Tests (LFTs) of Uncertain Cause and the Total.

Secondary Outcome Measures :
  1. The Number of Procedural Complications [ Time Frame: 24 months ]
    Major procedural complications could include: hospitalization, surgery or a radiologic procedure to correct an adverse event; bleeding, infection. Minor procedural complications could be increase in abdominal pain, self-limited hypoxia, bradycardia, tachycardia, hypo or hyper-tension, change in vital signs.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients between the ages of 18 and 70 years old referred to Indiana University Hospital for outpatient upper EUS for clinical purposes (e.g., pancreatic disease).
  2. Increased hepatic enzymes (AST or ALT) above the upper limit of normal within the past 3 months. These values at University Hospital are ALT>45 U/L and AST> 41 U/L but may vary among laboratories at different institutions.
  3. Evidence of fatty liver (as detected by an increase in echogenicity or brightness of the liver) by EUS exam.
  4. Liver biopsy for suspected NAFLD is clinically indicated as determined by Dr Naga Chalasani, one of our staff hepatologists who is an expert in NAFLD.

Exclusion Criteria:

  1. Inpatient status.
  2. Normal liver enzyme tests (AST, ALT).
  3. Previous or current alcohol abuse (≥3 drinks/day for men; ≥2 drinks/day for women)
  4. Planned liver biopsy within 30 days for known or suspected liver disease.
  5. Suspected metastatic lesion in the liver by any previous imaging study or discovered during EUS exam.
  6. EUS-FNA of the liver is required for another reason (i.e. suspected metastatic lesion)
  7. Newly diagnosed, currently treated or suspected malignancy. (In this case, the diagnosis of NAFLD would not likely impact patient care or survival). Patients with a previously diagnosed malignancy that is in remission will be considered eligible.
  8. Previously diagnosed NAFLD including steatosis or NASH (in this situation, another biopsy is not beneficial to the patient).
  9. Chronic liver disease including Hepatitis B, Hepatitis C, Wilson's disease, alpha-1-antitrypsin disease, autoimmune hepatitis.
  10. Known or suspected cirrhosis.
  11. Esophageal or gastric varices by previous imaging or discovered during EUS.
  12. Previous liver surgery including resection or transplant.
  13. Thrombocytopenia (platelets <150,000)
  14. Anemia (hemoglobin <10 gm/dL).
  15. Coagulopathy (INR>1.2 or aPTT > 35 secs).
  16. Use of coumadin or other anticoagulants.
  17. Use of aspirin or nonsteroidal antinflammatory product within 7 days of EUS.
  18. Total bilirubin >2.0 mg/dL and dilated bile duct on previous imaging study.
  19. Inability to provide informed consent.
  20. Pregnancy or suspected pregnancy.

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 identifier (NCT number): NCT00586313

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United States, Indiana
University Hospital
Indianapolis, Indiana, United States, 46202-5121
Sponsors and Collaborators
Indiana University
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Principal Investigator: John M. DeWitt, M.D. Indiana University School of Medicine

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Indiana University Identifier: NCT00586313     History of Changes
Other Study ID Numbers: 0608-17
First Posted: January 4, 2008    Key Record Dates
Results First Posted: November 30, 2015
Last Update Posted: October 17, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Indiana University:
EUS Biopsy for Non-alcoholic Fatty Liver Disease
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases
Liver Extracts