This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Ultrasound Method to Measure Fibrosis of the Liver in Children (NCT02086708), a na na study. The primary outcome is Measure Liver Elasticity Value Using Sonoelastography..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02086708 |
| Phase | NA |
| Condition | Chronic Liver Disease, Non-Alcoholic Fatty Liver Disease, HCV Coinfection |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 24 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Massachusetts General Hospital |
| Results posted | Yes |
2. Clinical Question
Population
Children and adolescents with suspected diffuse liver disease who were scheduled for a nonfocal liver biopsy as part of routine clinical care. The listed conditions include chronic liver disease, non-alcoholic fatty liver disease, HCV coinfection, HBV, and drug-induced liver injury. The registry does not report further eligibility details or the characteristics of the enrolled participants.
Intervention
Shear wave sonoelastography, a device-based ultrasound method used to measure liver stiffness. The study description says the measurement was performed in patients scheduled for a nonfocal liver biopsy.
Comparator
There was no separate randomized or control group. The planned reference for interpreting the stiffness measurement was liver biopsy, read by a single pathologist using METAVIR fibrosis stages F0-F4. This is a comparison between a measurement and a biopsy assessment, not a comparison between treatments.
Primary question
What mean liver elasticity value, measured in kPa by sonoelastography on Day one, was observed, and how did the measurement relate to biopsy fibrosis stage? The registry describes this endpoint and its intended biopsy reference, but the numerical endpoint results and any analysis of the relationship are not reported in the registry record.
3. Trial Design
This was a single-group device study of shear wave sonoelastography. The registry records planned enrollment of 24 and lists the study phase as NA. Allocation is recorded as NA, and masking is recorded as none. These entries do not describe a randomized treatment comparison; the registry specifically describes the measurement being made in patients scheduled for a nonfocal liver biopsy.
The study population was pediatric and adolescent patients with suspected diffuse liver disease. The listed conditions were chronic liver disease, non-alcoholic fatty liver disease, HCV coinfection, HBV, and drug-induced liver injury. The registry does not report the eligibility criteria in enough detail to determine how participants were selected from these diagnostic groups, or whether every listed condition was represented among those enrolled.
The intervention was shear wave sonoelastography. The primary endpoint was mean liver elasticity in kPa, measured on Day one. The endpoint description says that liver stiffness was to be assessed alongside biopsy results read by a single pathologist using METAVIR criteria, from F0-F4. Thus, the design concerns the measurement of stiffness and its relation to a tissue-based fibrosis assessment, rather than an intervention intended to change a health outcome.
The sponsor was Massachusetts General Hospital. The record lists a start of 2010-06 and primary completion of 2015-03, and the study status is terminated. It does not report why the study was terminated, whether enrollment was completed as planned, or whether the endpoint was measured for all enrolled participants. The statistical analysis plan, sample-size justification, and details of any interim analyses are not reported in the registry record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Shear Wave Sonoelastography, Fibrosis |
|---|---|
| STARTED | 24 |
| COMPLETED | 24 |
| NOT COMPLETED | 0 |
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: Pediatric and Adolescents
| Characteristic | Unit | Shear Wave Sonoelastography, Fibrosis |
|---|---|---|
| Participants analysed | 24 | |
| Age, Continuous | years | 17 (1 to 21) |
| Gender: Female | Participants | 11 |
| Gender: Male | Participants | 13 |
| Region of Enrollment: United States | participants | 24 |
6. Primary Endpoint
The registry lists the primary outcome as Measure Liver Elasticity Value Using Sonoelastography., measured over Day one.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | 95% Confidence Interval |
| Unit | kPa |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is mean liver elasticity measured by sonoelastography, expressed in kPa, at Day one. This is a continuous measure: rather than placing every participant directly into a category, it represents a numerical estimate of liver stiffness. The registry specifies a 95% confidence interval as the dispersion measure, but the endpoint's numerical mean and interval are not reported in the registry record.
The endpoint is intended to be considered alongside the liver biopsy result. Biopsy was read by a single pathologist using METAVIR criteria, which classify fibrosis from F0-F4. The purpose of this reference is to examine whether the ultrasound-based stiffness measurement corresponds to fibrosis stage. The registry describes this purpose but does not report stage-specific stiffness values, an estimated association, or diagnostic performance results.
As a general statistical point, a continuous endpoint can retain variation in measurements that would be lost if values were immediately reduced to categories. A confidence interval communicates uncertainty around an estimated mean under the analysis assumptions; it does not show the range of individual participants' values. The interval's width and location would be needed to judge the precision and scale of the reported mean, but neither is available in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The record identifies the intended measurement and its clinical reference, but does not provide the primary endpoint result. In particular, no mean liver elasticity value or 95% confidence interval is reported in the registry record. The posted information therefore does not establish the observed stiffness level, its precision, or how measurements varied across METAVIR stages.
The study is described as a single-group investigation of a device measurement. It does not include a randomized comparison of treatments, and the registry does not define a separate control arm. Biopsy staging is the stated reference for assessing liver stiffness, rather than a treatment comparator. This distinction matters: the design question is about how an ultrasound measurement relates to a biopsy assessment, not whether one therapy is better than another.
The endpoint description says that biopsy results were read by a single pathologist using METAVIR criteria from F0-F4. However, the registry does not report the observed distribution of participants across fibrosis stages, the elasticity values within any stage, or a statistical estimate relating the measurement to stage. Without those results, readers cannot assess whether values were separated across stages, whether estimates were precise, or whether any apparent pattern was consistent.
The registry lists planned enrollment of 24, but enrollment alone does not supply the endpoint analysis. The number with an evaluable sonoelastography measurement and biopsy result, the analysis population, and the handling of missing measurements are not reported in the registry record. It is therefore not possible to tell from this record whether the endpoint analysis used everyone enrolled or a subset.
The status is terminated. That status is important context but does not, by itself, explain why the study ended, whether the planned enrollment was reached, or whether results were analyzed. Reasons for termination and the study's statistical plan are not reported in the registry record. No outcome analyses are listed, so there is no sponsor-reported estimate or inferential result to interpret.
Any planning illustration based on an observed effect should be read as a design aid, not as evidence about the study's power or outcome. In this record, the primary result needed to interpret such an illustration is not reported. General statistical considerations, such as the importance of adequate precision and complete measurement-reference pairs, cannot substitute for the missing observed endpoint results.
Accordingly, the posted record supports a description of the question and measurement approach, but not a conclusion about the strength, accuracy, or clinical usefulness of sonoelastography for staging fibrosis in this population. Such claims would require results that are not reported in the registry record.
9. Statistical Methods Explained
The registry identifies a continuous primary measure: mean liver elasticity in kPa, assessed on Day one. It also specifies a 95% confidence interval. The record does not list an analysis count or report a numerical estimate, so there is no sponsor-reported primary analysis to interpret. The methods below explain how the stated endpoint and reference could be understood in general; they do not imply that any particular analysis was performed.
What does a mean represent?
A mean describes the central level of a continuous measurement in the population included in an analysis. For this endpoint, it would summarize measured liver elasticity. The mean alone would not describe the spread of individual measurements or show how closely each participant's value corresponded to biopsy stage. A mean for the full analysis population would also answer a different question from means calculated separately by fibrosis stage. The registry does not report which, if any, such summaries were calculated.
What does the confidence interval communicate?
In general, a confidence interval expresses statistical uncertainty around an estimate under specified sampling and analysis assumptions. A narrower interval indicates greater precision for the estimated quantity, while a wider interval indicates more uncertainty. It is not a range expected to contain every participant's measurement, and it does not by itself establish that a measurement is clinically useful. The registry names a 95% confidence interval as the dispersion measure but does not report its limits or describe how it was calculated.
How is the biopsy reference relevant?
The study description links sonoelastography-measured stiffness to biopsy results read by a single pathologist using METAVIR criteria from F0-F4. This gives the measurement a stated reference for examining fibrosis. A statistical analysis could describe the distribution of stiffness across biopsy stages or estimate an association between stiffness and stage. Those are general analytic possibilities, not reported findings. The record gives no stage-specific measurements, association estimate, classification thresholds, or measures of diagnostic performance.
Why does the design matter?
This is a single-group measurement study, not a randomized comparison of therapies. The registry records allocation as NA and masking as none. Consequently, the central statistical issue is the quality and interpretation of the measurement-reference relationship, rather than estimation of a treatment effect against a control arm. A relation between the two assessments, if observed, would not on its own establish that the ultrasound measurement can replace biopsy or that using it changes patient outcomes.
General measurement studies also depend on how measurements are obtained and how the reference is assessed. The registry states that a single pathologist read biopsy results, but does not describe reader blinding, repeatability procedures, ultrasound acquisition details, or the handling of disagreements or technically inadequate measurements. These design details are not reported in the registry record, so their influence cannot be evaluated.
What can be inferred from the absence of analyses?
The registry lists no analyses. No statistical model, hypothesis test, adjustment strategy, or analysis population is described in the posted record. It is not appropriate to infer that a particular method was used simply because a continuous endpoint and a fibrosis staging reference are named. Nor can an analysis be reconstructed without the underlying measurements and participant-level stage information.
General statistical interpretation would require an estimate and its uncertainty, plus enough information to understand who contributed data and how the comparison was made. For a measurement intended to reflect ordered fibrosis stages, readers would also need to know how the analysis treated stage and what performance question it addressed. Those details and results are not reported in the registry record.
How should planning calculations be read?
In general, a sample-size calculation is a planning exercise based on assumptions about the effect to detect, variability, significance level, allocation, and statistical method. It is not observed power and cannot establish that an analysis detected an effect. Any planning illustration derived from an observed effect should remain a planning illustration, not a result. Because the primary outcome values and analysis are not reported in the registry record, no conclusion about the observed precision or adequacy of the study's statistical power follows from enrollment alone.
Overall, the registered endpoint and reference describe a reasonable statistical question: how a continuous ultrasound stiffness measure relates to biopsy-based fibrosis stage. But the record does not report the estimates or methods needed to answer that question empirically. General principles clarify what such results would mean; they cannot fill the results gap.
10. Multiplicity, Missing Data and Analysis Populations
The registry identifies one primary outcome measure and lists no analyses. It does not report a statistical analysis plan, prespecified hypothesis tests, secondary endpoints, or any approach to multiplicity. Multiplicity concerns arise when multiple outcomes, comparisons, subgroups, or repeated tests are assessed; without a reported analysis plan and results, it is not possible to determine whether or how this issue was addressed. No adjustment method should be inferred.
The analysis population is not specified. The record lists planned enrollment of 24, but does not report how many participants had usable sonoelastography measurements, biopsy results, or paired measurements. It also does not report whether all enrolled participants were included in the primary analysis, or whether exclusions occurred.
Missing-data methods are not described in the registry record. There is no report of missing measurements, reasons for missingness, imputation, or sensitivity analyses. In general, missing data can affect an estimate if participants with available measurements differ systematically from those without them. Without details on missingness and its handling, readers cannot assess this possibility for the endpoint.
The record does not describe interim analyses, stopping rules, or a sample-size justification. The terminated status does not clarify whether termination was related to enrollment, data availability, or any analysis. These details are not reported in the registry record, so the impact of study conduct on the endpoint estimate cannot be evaluated.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Fibrosis 0 | 0 | 10 | 0.0% |
| Fibrosis 1 | 0 | 9 | 0.0% |
| Fibrosis 2 | 0 | 1 | 0.0% |
| Fibrosis 3 | 0 | 3 | 0.0% |
| Fibrosis 4 | 0 | 1 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Fibrosis 0 | 0 of 10 |
| Fibrosis 1 | 0 of 9 |
| Fibrosis 2 | 0 of 1 |
| Fibrosis 3 | 0 of 3 |
| Fibrosis 4 | 0 of 1 |
The registry lists adverse-event counts by fibrosis-stage group, rather than by randomized treatment arm. For Fibrosis 0, Fibrosis 1, Fibrosis 2, Fibrosis 3, and Fibrosis 4, the recorded number at risk is respectively 10, 9, 1, 3, and 1 in each of the serious and other adverse-event categories. The registry reports zero affected participants in every listed stage group for both categories.
These entries describe the posted counts; they do not establish that no adverse experiences occurred outside the registry's reporting scope or observation period. The record does not describe event collection procedures, follow-up duration for safety, or the definitions used for serious and other events. Death counts are recorded as null, which means a death count is not reported in these entries; it should not be interpreted as a reported zero.
The stage groups are not treatment arms, and the repeated at-risk counts should not be added across categories. The listed safety information alone cannot support a comparative safety conclusion. No serious adverse-event terms are listed in the record.
12. What the Result Does, and Does Not, Mean
This registry record describes an investigation of shear wave sonoelastography as a way to measure liver stiffness in pediatric and adolescent patients with suspected diffuse liver disease. Its primary endpoint is mean liver elasticity in kPa on Day one, with biopsy stage assessed using METAVIR criteria from F0-F4 as the stated reference. The record therefore identifies a measurement question that is distinct from a treatment-effect question.
The posted results do not include a numerical mean, a 95% confidence interval, stage-specific values, or an analysis relating stiffness to biopsy stage. The registry lists no analyses. As a result, readers cannot determine from this record how much stiffness was measured, how precise the estimate was, whether values varied by stage, or how well the ultrasound measurement corresponded to biopsy findings.
This absence of reported results should not be turned into a positive or negative conclusion about the device. The record does not show that the measurement was accurate, inaccurate, useful, or ineffective. It also does not report whether use of the measurement changed clinical decisions or patient outcomes. Those conclusions would require evidence that is not reported in the registry record.
More generally, a measurement's association with a reference assessment is not by itself proof that it can replace that reference or guide care safely. Interpretation would depend on the observed values, uncertainty, analysis methods, completeness of paired assessments, and the clinical context in which the test might be used. The record does not provide enough information to evaluate those matters.
The termination status is a factual study status, not an explanation of the results. The reason for termination and whether the planned enrollment was completed are not reported in the registry record. The most defensible reading is therefore limited: the study was designed to examine a noninvasive stiffness measurement alongside biopsy staging, but the registry does not report the endpoint findings needed to judge the measurement's performance.
13. Why This Trial Matters Statistically
The study addresses a statistical question about measurement: whether an ultrasound-derived continuous stiffness value corresponds to a biopsy-based fibrosis stage in children and adolescents. That framing matters because the evidence needed is not simply a treatment comparison or a count of adverse events. It requires a clear description of paired measurement and reference data, along with estimates that show both the observed pattern and its uncertainty.
The endpoint is stated in a clinically interpretable unit, kPa, and the biopsy reference is identified as a single-pathologist METAVIR assessment from F0-F4. These definitions make the intended analysis understandable at a conceptual level. They also highlight what would be required for statistical evaluation: reported measurement summaries, stage-specific findings or another prespecified relationship estimate, and enough information to assess precision and completeness.
The record's single-group design is appropriate to distinguish from a randomized clinical trial. There is no treatment-control contrast to interpret. Instead, any conclusion would depend on how well the measurement tracks the reference and on the limitations of the measurement and biopsy assessments. The registry does not report the analyses needed to examine that relationship.
The record is also a useful example of why registration details and outcome reporting are different. A named endpoint, target population, and measurement procedure specify the study's question, but they do not supply the results. Without the endpoint estimate, its confidence interval, and an analysis description, statistical readers cannot judge the degree of evidence or uncertainty.
The terminated status and planned enrollment provide context, but do not resolve the missing results. Why the study ended and whether the planned enrollment was reached are not reported in the registry record. The statistical importance of this study therefore lies in its clearly framed measurement question, while its empirical contribution cannot be assessed from the posted results.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The principal limitation for interpreting this record is that the primary endpoint result is not reported. Although the endpoint is defined as mean liver elasticity in kPa with a 95% confidence interval, neither the mean nor the interval is available. The registry also does not report stage-specific measurements or an estimate of the relationship between elasticity and METAVIR stage.
The registry lists planned enrollment of 24, but does not report the number with complete paired sonoelastography and biopsy data. The analysis population, missing measurements, exclusions, and methods for handling missing data are not reported in the registry record. The extent to which the analyzed participants, if any, represent the enrolled population therefore cannot be judged.
Important methodological details are also absent. The registry does not describe ultrasound acquisition, repeatability, operator training, reader blinding, or how biopsy sampling and interpretation were handled beyond identifying a single pathologist and METAVIR criteria. The statistical analysis plan and any prespecified method for assessing measurement performance are not reported.
The study status is terminated, but the reason for termination and whether planned enrollment was completed are not reported. The record lists no analyses, so there are no sponsor-reported estimates to assess. These limitations prevent a meaningful evaluation of precision, measurement agreement, stage discrimination, or generalizability from this registry record alone.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Ultrasound Method to Measure Fibrosis of the Liver in Children — NCT02086708.
- Registry record last updated 2017-02-01; status last verified 2016-12.
- Results first posted 2017-02-01.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
NCT02086708, titled “Ultrasound Method to Measure Fibrosis of the Liver in Children,” is a single-group device study sponsored by Massachusetts General Hospital. It examined shear wave sonoelastography in pediatric and adolescent patients with suspected diffuse liver disease scheduled for nonfocal liver biopsy. Planned enrollment was 24; the record lists a start of 2010-06, primary completion of 2015-03, and status as terminated.
The primary endpoint was mean liver elasticity in kPa on Day one, intended to be considered alongside biopsy readings by a single pathologist using METAVIR criteria from F0-F4. The registry lists no analyses and does not report the endpoint estimate or confidence interval. The reason for termination, analysis population, missing-data handling, and statistical plan are not reported in the registry record.