N/A
N=21
Endoscopic Ultrasound(EUS)-Guided TRUCUT Biopsy (EUS-TCB) of Suspected Nonalcoholic Fatty Liver Disease(NAFLD.)
Non-alcoholic Fatty Liver Disease · Nonalcoholic Steatohepatitis
Bottom Line
View on ClinicalTrials.gov: NCT00586313 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Nov 2015
Primary outcome: Primary: Median Total Specimen Length — 8; 14; 8; 11.5 mm
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Tru-cut biopsy (Device); Tru-cut (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Indiana University
- Primary completion
- Jul 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Total Specimen Length |
8; 14; 8; 11.5; 9 | — |
| SECONDARY The Number of Procedural Complications |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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 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.
Data sourced from ClinicalTrials.gov (NCT00586313). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.