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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
Sponsor:
Information provided by (Responsible Party):
Indiana University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions Non-alcoholic Fatty Liver Disease
Nonalcoholic Steatohepatitis
Interventions Device: Tru-cut biopsy
Procedure: Tru-cut
Enrollment 21
Recruitment Details Consecutive subjects undergoing EUS with suspected hepatic parenchymal disease
Pre-assignment Details  
Arm/Group Title EUS Tru-cut Biopsy
Hide Arm/Group Description

Transgastric EUS-TCB may prove to be a safe alternative to percutaneous and transjugular liver biopsy methods in obtaining liver biopsy samples.

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.

Period Title: Overall Study
Started 21
Completed 19
Not Completed 2
Reason Not Completed
Lack of Efficacy             2
Arm/Group Title Participants Undergoing the Tru-Cut Biopsy
Hide Arm/Group Description

Transgastric EUS-TCB may prove to be a safe alternative to percutaneous and transjugular liver biopsy methods in obtaining liver biopsy samples.

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.

Overall Number of Baseline Participants 21
Hide Baseline Analysis Population Description
13 females
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
<=18 years
0
   0.0%
Between 18 and 65 years
21
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
Female
13
  61.9%
Male
8
  38.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 21 participants
21
1.Primary Outcome
Title Median Total Specimen Length
Hide Description 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.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title EUS Tru-cut Biopsy
Hide Arm/Group Description:

Transgastric EUS-TCB may prove to be a safe alternative to percutaneous and transjugular liver biopsy methods in obtaining liver biopsy samples.

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.

Overall Number of Participants Analyzed 21
Median (Full Range)
Unit of Measure: mm
Suspected NAFLD, n=9
8
(1 to 13)
Intrahepatic Cholestasis, n=4
14
(3 to 22)
Exclusion of Cirrhosis, n=4
8
(6 to 22)
Increased Liver Function Tests (LFTs), n=4
11.5
(6 to 23)
Total, n=21
9
(1 to 23)
2.Secondary Outcome
Title The Number of Procedural Complications
Hide Description 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.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title EUS Tru-cut Biopsy
Hide Arm/Group Description:

Transgastric EUS-TCB may prove to be a safe alternative to percutaneous and transjugular liver biopsy methods in obtaining liver biopsy samples.

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.

Overall Number of Participants Analyzed 21
Measure Type: Number
Unit of Measure: complications
0
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title EUS Tru-cut Biopsy
Hide Arm/Group Description

Transgastric EUS-TCB may prove to be a safe alternative to percutaneous and transjugular liver biopsy methods in obtaining liver biopsy samples.

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.

All-Cause Mortality
EUS Tru-cut Biopsy
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
EUS Tru-cut Biopsy
Affected / at Risk (%)
Total   0/21 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
EUS Tru-cut Biopsy
Affected / at Risk (%)
Total   0/21 (0.00%) 
The small sample size and low-risk population.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: John DeWitt, MD
Organization: Indiana University Hospital
Phone: 317-944-1113
EMail: jodewitt@iu.edu
Layout table for additonal information
Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT00586313     History of Changes
Other Study ID Numbers: 0608-17
First Submitted: December 21, 2007
First Posted: January 4, 2008
Results First Submitted: March 17, 2014
Results First Posted: November 30, 2015
Last Update Posted: October 17, 2016