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

Completed · Not applicable

Conditions studied: Non-alcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis

In brief

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.

Key facts

Study ID

NCT00586313

Run by

Indiana University

People needed

21

Starts

2007-01-01

Expected to finish

2008-07-01

Last updated by the study team

2016-10-17

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).
• 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.
• Evidence of fatty liver (as detected by an increase in echogenicity or brightness of the liver) by EUS exam.
• 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.

You may not qualify if…

• Inpatient status.
• Normal liver enzyme tests (AST, ALT).
• Previous or current alcohol abuse (≥3 drinks/day for men; ≥2 drinks/day for women)
• Planned liver biopsy within 30 days for known or suspected liver disease.
• Suspected metastatic lesion in the liver by any previous imaging study or discovered during EUS exam.
• EUS-FNA of the liver is required for another reason (i.e. suspected metastatic lesion)
• 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.
• Previously diagnosed NAFLD including steatosis or NASH (in this situation, another biopsy is not beneficial to the patient).
• Chronic liver disease including Hepatitis B, Hepatitis C, Wilson's disease, alpha-1-antitrypsin disease, autoimmune hepatitis.
• Known or suspected cirrhosis.
• Esophageal or gastric varices by previous imaging or discovered during EUS.
• Previous liver surgery including resection or transplant.
• Thrombocytopenia (platelets <150,000)
• Anemia (hemoglobin <10 gm/dL).
• Coagulopathy (INR>1.2 or aPTT > 35 secs).
• Use of coumadin or other anticoagulants.
• Use of aspirin or nonsteroidal antinflammatory product within 7 days of EUS.
• Total bilirubin >2.0 mg/dL and dilated bile duct on previous imaging study.
• Inability to provide informed consent.
• Pregnancy or suspected pregnancy.

Where it is running

• University Hospital — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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