An interventional study of Shear Wave sonoelastography in Chronic Liver Disease, Non-Alcoholic Fatty Liver Disease and HCV Coinfection, sponsored by Massachusetts General Hospital. Terminated at 1 site in United States. Open to participants aged 1 Year to 21 Years. Per ClinicalTrials.gov, last updated 2017-02-01.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Diagnostic
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.
154 studies on the registry are indexed under Coinfection; 16 are open to participants now.
This study's enrollment of 24 is below the median of 75 across 95 interventional studies indexed under Coinfection.
Browse Coinfection studies →Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
Shear Wave sonoelastography is performed on patients who are scheduled for a non-focal liver biopsy.
Device: 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 of fibrosis from liver biopsy.
Also known as: Supersonic Aixplorer
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
1. Patients scheduled for Liver Biopsy 2.
| Milestone | Shear Wave Sonoelastography, Fibrosis |
|---|---|
| Started | 24 |
| Completed | 24 |
| Not completed | 0 |
Assess liver stiffness as measured by sonoelastography with results of liver biopsy as read by a single-pathologist using the METAVIR criteria (F0-F4).
| kPa | Fibrosis 0 | Fibrosis 1 | Fibrosis 2 | Fibrosis 3 | Fibrosis 4 |
|---|---|---|---|---|---|
| Measure Liver Elasticity Value Using Sonoelastography. | 6.93 (6.33 to 7.44) | 8.33 (6.83 to 10.80) | 6.12 (NA to NA) | 8.86 (5.7 to 11.4) | 17.85 (NA to NA) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Fibrosis 0 | — | 0/10 (0%) | 0/10 (0%) |
| Fibrosis 1 | — | 0/9 (0%) | 0/9 (0%) |
| Fibrosis 2 | — | 0/1 (0%) | 0/1 (0%) |
| Fibrosis 3 | — | 0/3 (0%) | 0/3 (0%) |
| Fibrosis 4 | — | 0/1 (0%) | 0/1 (0%) |
Pediatric and Adolescents
| Age, Continuous(years) | Shear Wave Sonoelastography, Fibrosis |
|---|---|
| Mean | 17 (1 to 21) |
| Gender(Participants) | Shear Wave Sonoelastography, Fibrosis |
|---|---|
| Female | 11 |
| Male | 13 |
| Region of Enrollment(participants) | Shear Wave Sonoelastography, Fibrosis |
|---|---|
| United States | 24 |
Plan to share: Undecided
This study is terminated, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.
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Massachusetts General Hospital