Chronic Liver Disease, Drug-Induced Liver Injury, HBV, HCV Coinfection, Non-Alcoholic Fatty Liver Disease
Conditions
Keywords
Sonoelastography,, Diffuse liver disease,, chronic liver disease,, NASH,, NAFLD,, Elevated Transaminases,, Liver Biopsy,, Fibrosis,, METAVIR
Brief summary
HYPOTHESIS: The investigators hypothesize that sonoelastography (SE) provide accurate quantitative measurements that can be used to stage liver fibrosis in pediatric patients with chronic liver disease. Specific Aims: To measure liver stiffness with sonoelastography in pediatric and adolescents with suspect diffuse liver disease who will undergo nonfocal liver biopsy as part of their routine clinical care.
Interventions
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 of fibrosis from liver biopsy.
Sponsors
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 21 Years
Healthy volunteers
No
Inclusion criteria
* Patients scheduled for random liver biopsy for routine staging of liver fibrosis * Pediatric patients patients (ages 1-21) * Girls or boys * Suspected liver disease * Consent to participate in the study
Exclusion criteria
* Pregnancy * Acute illness/cognitive impairment resulting in inability to cooperate with ultrasound * Patients that do not consent to ultrasound guided liver biopsy. * Contraindications to liver biopsy (e.g. low platelets defined as a platelet count of less than 50,000, and hemophilia/coagulopathy as an INR higher than 1.5.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measure Liver Elasticity Value Using Sonoelastography. | Day one | Assess liver stiffness as measured by sonoelastography with results of liver biopsy as read by a single-pathologist using the METAVIR criteria (F0-F4). |
Countries
United States
Participant flow
Recruitment details
1\. Patients scheduled for Liver Biopsy 2.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 24 |
| Total | 24 |
Baseline characteristics
| Characteristic | Shear Wave Sonoelastography, Fibrosis |
|---|---|
| Age, Continuous | 17 years |
| Gender Female | 11 Participants |
| Gender Male | 13 Participants |
| Region of Enrollment United States | 24 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 10 | 0 / 9 | 0 / 1 | 0 / 3 | 0 / 1 |
| serious Total, serious adverse events | 0 / 10 | 0 / 9 | 0 / 1 | 0 / 3 | 0 / 1 |
Outcome results
Primary
Measure Liver Elasticity Value Using Sonoelastography.
Assess liver stiffness as measured by sonoelastography with results of liver biopsy as read by a single-pathologist using the METAVIR criteria (F0-F4).
Time frame: Day one
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Fibrosis 0 | Measure Liver Elasticity Value Using Sonoelastography. | 6.93 kPa |
| Fibrosis 1 | Measure Liver Elasticity Value Using Sonoelastography. | 8.33 kPa |
| Fibrosis 2 | Measure Liver Elasticity Value Using Sonoelastography. | 6.12 kPa |
| Fibrosis 3 | Measure Liver Elasticity Value Using Sonoelastography. | 8.86 kPa |
| Fibrosis 4 | Measure Liver Elasticity Value Using Sonoelastography. | 17.85 kPa |