Trial Outcomes & Findings for Endoscopic Ultrasound(EUS)-Guided TRUCUT Biopsy (EUS-TCB) of Suspected Nonalcoholic Fatty Liver Disease(NAFLD.) (NCT NCT00586313)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

21 participants

Primary outcome timeframe

24 months

Results posted on

2016-10-17

Participant Flow

Consecutive subjects undergoing EUS with suspected hepatic parenchymal disease

Participant milestones

Participant milestones
Measure	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. 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 Study STARTED	21
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	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. 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 Study Lack of Efficacy	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Participants Undergoing the Tru-Cut Biopsy n=21 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	EUS Tru-cut Biopsy n=21 Participants 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.
Median Total Specimen Length Total, n=21	9 mm Interval 1.0 to 23.0
Median Total Specimen Length Suspected NAFLD, n=9	8 mm Interval 1.0 to 13.0
Median Total Specimen Length Intrahepatic Cholestasis, n=4	14 mm Interval 3.0 to 22.0
Median Total Specimen Length Exclusion of Cirrhosis, n=4	8 mm Interval 6.0 to 22.0
Median Total Specimen Length Increased Liver Function Tests (LFTs), n=4	11.5 mm Interval 6.0 to 23.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	EUS Tru-cut Biopsy n=21 Participants 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.
The Number of Procedural Complications	0 complications

Adverse Events

EUS Tru-cut Biopsy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

John DeWitt, MD

Indiana University Hospital

Phone: 317-944-1113

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place