Trial Outcomes & Findings for Ultrasound Method to Measure Fibrosis of the Liver in Children (NCT NCT02086708)
NCT ID: NCT02086708
Last Updated: 2017-02-01
Results Overview
Assess liver stiffness as measured by sonoelastography with results of liver biopsy as read by a single-pathologist using the METAVIR criteria (F0-F4).
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
24 participants
Primary outcome timeframe
Day one
Results posted on
2017-02-01
Participant Flow
1\. Patients scheduled for Liver Biopsy 2.
Participant milestones
| Measure |
Shear Wave Sonoelastography, Fibrosis
Shear Wave sonoelastography is performed on patients who are scheduled for a non-focal liver biopsy.
Shear Wave sonoelastography: Shear Wave Sonoelastography as a ultrasound technique to measure liver fibrosis is performed on patients scheduled for non-focal liver biopsy. Results are compared with pathological score from liver biopsy.
|
|---|---|
|
Overall Study
STARTED
|
24
|
|
Overall Study
COMPLETED
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ultrasound Method to Measure Fibrosis of the Liver in Children
Baseline characteristics by cohort
| Measure |
Shear Wave Sonoelastography, Fibrosis
n=24 Participants
Shear Wave sonoelastography is performed on patients who are scheduled for a non-focal liver biopsy.
Shear Wave sonoelastography: Shear Wave Sonoelastography as a ultrasound technique to measure liver fibrosis is performed on patients scheduled for non-focal liver biopsy. Results are compared with pathological score from liver biopsy.
|
|---|---|
|
Age, Continuous
|
17 years
n=5 Participants
|
|
Gender
Female
|
11 Participants
n=5 Participants
|
|
Gender
Male
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day oneAssess liver stiffness as measured by sonoelastography with results of liver biopsy as read by a single-pathologist using the METAVIR criteria (F0-F4).
Outcome measures
| Measure |
Fibrosis 0
n=10 Participants
Patients with no Fibrosis on liver biopsy evaluation
|
Fibrosis 1
n=9 Participants
Patients with liver biopsy METAVIR stage 1 on pathology evaluation
|
Fibrosis 2
n=1 Participants
Patients with liver biopsy METAVIR stage 2 on pathology evaluation
|
Fibrosis 3
n=3 Participants
Patients with liver biopsy METAVIR stage 3 on pathology evaluation
|
Fibrosis 4
n=1 Participants
Patients with liver biopsy METAVIR stage 4 on pathology evaluation
|
|---|---|---|---|---|---|
|
Measure Liver Elasticity Value Using Sonoelastography.
|
6.93 kPa
Interval 6.33 to 7.44
|
8.33 kPa
Interval 6.83 to 10.8
|
6.12 kPa
For 1 subject, 95% confidence intervals cannot be calculated.
|
8.86 kPa
Interval 5.7 to 11.4
|
17.85 kPa
For 1 subject, 95% confidence intervals cannot be calculated.
|
Adverse Events
Fibrosis 0
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Fibrosis 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Fibrosis 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Fibrosis 3
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Fibrosis 4
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place