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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT00586313
First received: December 21, 2007
Last updated: November 6, 2013
Last verified: April 2013
  Purpose

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
Fatty Liver Disease.
Endoscopic Ultrasound Tru-Cut Biopsy.
Device: EUS 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:
  • To evaluate the utility, diagnostic yield and complications of EUS-TCB for the histologic diagnosis of suspected NAFLD. This is a "proof of concept" pilot study. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Transgastric EUS-TCB may prove to be a safe alternative to percutaneous and transjugular liver biopsy methods in obtaining liver biopsy samples [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Enrollment: 15
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
Active Comparator: a1
Transgastric EUS-TCB may prove to be a safe alternative to percutaneous and transjugular liver biopsy methods in obtaining liver biopsy samples.
Device: EUS Tru-cut biopsy
Transgastric EUS-TCB may prove to be a safe alternative to percutaneous and transjugular liver biopsy methods in obtaining liver biopsy samples. This technique may be particularly helpful to obtain liver biopsies in patients with morbid obesity or patients in whom there is no obtainable view to obtain a percutaneous biopsy.
Other Name: Wilson-Cook 19 Gauge Quick-Core EUS Biopsy Needle.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

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

No publications provided

Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT00586313     History of Changes
Other Study ID Numbers: 0608-17
Study First Received: December 21, 2007
Last Updated: November 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
EUS Tru-Cut biopsy for Fatty liver disease.

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

ClinicalTrials.gov processed this record on April 16, 2014