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||Phase|
|Non-alcoholic Fatty Liver Disease Nonalcoholic Steatohepatitis||Device: Tru-cut biopsy Procedure: Tru-cut||Not Applicable|
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|
|Actual Primary Completion Date :||July 2008|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|