Endoscopic Ultrasound(EUS)-Guided TRUCUT Biopsy (EUS-TCB) of Suspected Nonalcoholic Fatty Liver Disease(NAFLD.) (NAFLD)
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|ClinicalTrials.gov Identifier: NCT00586313|
Recruitment Status : Completed
First Posted : January 4, 2008
Results First Posted : November 30, 2015
Last Update Posted : October 17, 2016
|Condition or disease||Intervention/treatment|
|Non-alcoholic Fatty Liver Disease Nonalcoholic Steatohepatitis||Device: Tru-cut biopsy Procedure: Tru-cut|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Endoscopic Ultrasound(EUS)-Guided TRUCUT Biopsy (EUS-TCB) of Suspected Nonalcoholic Fatty Liver Disease(NAFLD.)|
|Study Start Date :||January 2007|
|Primary Completion Date :||July 2008|
|Study Completion Date :||July 2008|
U.S. FDA Resources
Experimental: a1: Tru-Cut biopsy for liver
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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00586313
|United States, Indiana|
|Indianapolis, Indiana, United States, 46202-5121|
|Principal Investigator:||John M. DeWitt, M.D.||Indiana University School of Medicine|