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

This study has been completed.
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
First received: December 21, 2007
Last updated: October 27, 2015
Last verified: October 2015
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 Intervention
Non-alcoholic Fatty Liver Disease
Nonalcoholic Steatohepatitis
Device: Tru-cut biopsy

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Endoscopic Ultrasound(EUS)-Guided TRUCUT Biopsy (EUS-TCB) of Suspected Nonalcoholic Fatty Liver Disease(NAFLD.)

Resource links provided by NLM:

Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Median Total Specimen Length [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    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:
  • The Number of Procedural Complications [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    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.

Enrollment: 21
Study Start Date: January 2007
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 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.
Device: Tru-cut biopsy
Try-cut biopsy may prove to be a safe alternative to percutaneous and transjugular liver biopsy methods in obtaining liver biopsy samples

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Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00586313

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

Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT00586313     History of Changes
Other Study ID Numbers: 0608-17
Study First Received: December 21, 2007
Results First Received: March 17, 2014
Last Updated: October 27, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
EUS Biopsy for Non-alcoholic Fatty Liver Disease

Additional relevant MeSH terms:
Fatty Liver
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on December 01, 2015