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Trial Outcomes & Findings for Sonoelastography: Ultrasound Method to Measure Liver Fibrosis (NCT NCT01747772)

NCT ID: NCT01747772

Last Updated: 2017-06-14

Results Overview

Liver elasticity/stiffness was assessed via SE and compared against results of liver biopsy as read by a single pathologist using the Meta-analysis of Histological Data in Viral Hepatitis (METAVIR) 5-point scale (F \[Fibrosis\]0=no fibrosis, F1=portal fibrosis without septa, F2=portal fibrosis with few septa, F3=numerous septa without cirrhosis, and F4=cirrhosis). Using SE, fibrosis is measured in kilopascals (kPa) with normal values equaling approximately 5.5 kPa (normal liver stiffness ranges between 3.3-7.8 kPa). Significant Fibrosis (F3): = or \> 7.6 kPa, Cirrhosis (F4): = or \> 9.0- 26 kPa. A higher number corresponds to an increase in stiffness and hepatic fibrosis.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

180 participants

Primary outcome timeframe

Day 1

Results posted on

2017-06-14

Participant Flow

Patients known to have or suspected of having diffuse liver disease who were scheduled for ultrasound-guided non-focal liver biopsy were eligible for the study.

Participant milestones

Participant milestones
Measure
Shear Wave Sonoelastography for Fibrosis Assessment
Shear Wave sonoelastography (SWE) was performed in patients who were scheduled for a non-focal liver biopsy.
Overall Study
STARTED
180
Overall Study
Analysis Population
164
Overall Study
COMPLETED
171
Overall Study
NOT COMPLETED
9

Reasons for withdrawal

Reasons for withdrawal
Measure
Shear Wave Sonoelastography for Fibrosis Assessment
Shear Wave sonoelastography (SWE) was performed in patients who were scheduled for a non-focal liver biopsy.
Overall Study
SWE Data Not Obtainable Prior to Biopsy
9

Baseline Characteristics

Sonoelastography: Ultrasound Method to Measure Liver Fibrosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Shear Wave Sonoelastography for Fibrosis Assessment
n=164 Participants
Shear Wave sonoelastography (SWE) was performed in patients who were scheduled for a non-focal liver biopsy.
Age, Continuous
48 years
STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male
Female
81 Participants
n=5 Participants
Sex: Female, Male
Male
83 Participants
n=5 Participants

PRIMARY outcome

Timeframe: Day 1

Population: The analysis population included all participants who completed the study and had adequate shear-wave sonoelastography (SWE) and liver biopsy data. 16 participants were excluded: 9 discontinued and 7 had inadequate SWE or biopsy data.

Liver elasticity/stiffness was assessed via SE and compared against results of liver biopsy as read by a single pathologist using the Meta-analysis of Histological Data in Viral Hepatitis (METAVIR) 5-point scale (F \[Fibrosis\]0=no fibrosis, F1=portal fibrosis without septa, F2=portal fibrosis with few septa, F3=numerous septa without cirrhosis, and F4=cirrhosis). Using SE, fibrosis is measured in kilopascals (kPa) with normal values equaling approximately 5.5 kPa (normal liver stiffness ranges between 3.3-7.8 kPa). Significant Fibrosis (F3): = or \> 7.6 kPa, Cirrhosis (F4): = or \> 9.0- 26 kPa. A higher number corresponds to an increase in stiffness and hepatic fibrosis.

Outcome measures

Outcome measures
Measure
Fibrosis 0
n=24 Participants
Participants with no fibrosis on liver biopsy evaluation.
Fibrosis 1
n=97 Participants
Participants with portal fibrosis without septa on liver biopsy evaluation.
Fibrosis 2
n=18 Participants
Participants with portal fibrosis with few septa on liver biopsy evaluation.
Fibrosis 3
n=18 Participants
Participants with numerous septa without cirrhosis on liver biopsy evaluation.
Fibrosis 4
n=7 Participants
Participants with cirrhosis on liver biopsy evaluation.
Liver Elasticity Value Measured Using Sonoelastography (SE)
7.225 kilopascals (kPa)
Interval 6.106 to 8.344
7.332 kilopascals (kPa)
Interval 6.903 to 7.762
8.548 kilopascals (kPa)
Interval 7.666 to 9.429
12.101 kilopascals (kPa)
Interval 8.464 to 15.738
10.469 kilopascals (kPa)
Interval 8.592 to 12.345

Adverse Events

Shear Wave Sonoelastography for Fibrosis Assessment

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

Anthony E. Samir MD

Division of Abdominal Imaging and Interventional Radiology, Massachusetts General Hospital

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place