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 Prospective Analysis of Value of Contrast-enhanced Sonography During Biopsies of Focal Liver Masses (NCT03040323), a non-randomized phase 4 study. The primary outcome is Complication Rate.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03040323 |
| Phase | Phase 4 |
| Condition | Liver Biopsy |
| Allocation | Non-Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 83 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Indiana University |
| Results posted | Yes |
2. Clinical Question
Population
The study concerned people undergoing biopsy of focal liver masses. The condition listed in the registry record is liver biopsy. Although the record lists enrollment as 83, it also says that patient recruitment was insufficient and that no outcome data were collected. It does not report the number of participants who underwent biopsy or contributed outcome information.
Intervention
The experimental method was liver biopsy preceded by contrast enhancement with Lumason 60.7Mg Powder for Injection. The study aimed to assess whether using contrast-enhanced sonography during biopsy was associated with different complication and success rates than the standard method. No results are available to quantify either outcome.
Comparator
The comparison method was liver biopsy without prior contrast enhancement, described as the standard method. The registry labels the allocation non-randomized, so the record does not describe assignment by chance. The characteristics of people receiving each method and how treatment choices were made are not reported in the registry record.
Primary question
The primary endpoint was the complication rate, assessed over 30 days. The question was whether complications differed between biopsies performed with prior Lumason contrast enhancement and biopsies performed without prior enhancement. The registry also lists success rate as a secondary outcome. Because the record says no data were collected for outcome measures, neither comparison has a reported result.
3. Trial Design
The registry identifies this as a Phase 4, parallel, non-randomized study with single masking. It describes two biopsy methods: prior contrast enhancement with Lumason 60.7Mg Powder for Injection and biopsy without prior contrast enhancement, which the record calls the standard method. Indiana University is listed as the sponsor. The record lists enrollment as 83.
The study was intended to compare complication and success rates between these methods of ultrasound guidance for biopsy of liver lesions. Its primary outcome was complication rate, with success rate listed as a secondary outcome. The complication outcome was assessed over 30 days. The registry records a start date of 2016-12-22 and a primary completion date of 2018-06-30, and gives the status as terminated.
The record attributes termination to insufficient patient recruitment and an internal IRB audit. It explicitly states that no data were collected for outcome measures. The listed enrollment therefore should not be interpreted as the number of participants with available outcome data, nor does the record explain how many people received either method. Details about recruitment, assignment to methods, masking procedures, and the reasons for choosing a method are not reported in the registry record.
Because the study was non-randomized, the methods were not assigned through random allocation according to the registry. In general, this matters because participant characteristics or clinical decisions may differ between groups. A comparison between groups can therefore reflect differences in who received each method as well as any association with the method itself. The registry record does not contain outcome results with which to assess such a comparison.
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 | Biopsy With Lumason | Biopsy With Placebos |
|---|---|---|
| STARTED | 0 | 0 |
| COMPLETED | 0 | 0 |
| NOT COMPLETED | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: Insufficient patient recruitment and following internal IRB audit study was abandoned/terminated. No data were collected for Outcome Measures
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: Insufficient patient recruitment and following internal IRB audit study was abandoned/terminated. The PI has left the institution and it is not clear if Baseline data were collected. No Baseline data are available
| Characteristic | Unit | Biopsy With Lumason | Biopsy With Placebos | Total |
|---|---|---|---|---|
| Participants analysed | 0 | 0 | 0 | |
| Age, Categorical: <=18 years | — | — | — | |
| Age, Categorical: Between 18 and 65 years | — | — | — | |
| Age, Categorical: >=65 years | — | — | — | |
| Sex: Female, Male: Female | — | — | — | |
| Sex: Female, Male: Male | — | — | — | |
| Region of Enrollment: United States | participants | — | — | — |
6. Primary Endpoint
The registry lists the primary outcome as Complication Rate, measured over 30 days.
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint was complication rate, assessed over 30 days. The registry defined a complication as any of the following: bleeding seen on post-biopsy CT or US; a drop in hemoglobin of more than 1.5 g/dL within one week after biopsy; or the need for hepatic artery embolization. These criteria combine imaging findings, a laboratory change, and a subsequent procedure into a single outcome definition.
In general, a composite endpoint can capture several kinds of events relevant to the study question. It may also make interpretation less straightforward, because the components can differ in severity, frequency, and how they are detected. The registry does not report component-specific results or explain whether each criterion was analyzed separately. It also does not report an observed complication rate, a between-method comparison, or a measure of uncertainty.
The endpoint was intended to evaluate complications following liver biopsy, but the record states that no data were collected for outcome measures. Thus, the stated definition describes what would count as a complication; it does not establish that complications were observed or absent in either group. The registry lists success rate as a secondary outcome, but it does not provide its definition or any results.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record contains no outcome data for the planned comparison. It says that insufficient patient recruitment and an internal IRB audit preceded termination, and explicitly states that no data were collected for outcome measures. Consequently, there is no reported complication rate for either biopsy method, no reported success rate, and no estimate of the difference between methods.
The adverse-event listing shows zero counts for the displayed categories in both groups. Those entries should not be read as evidence that no adverse events occurred: the record separately states that outcome data were not collected. In this setting, the displayed zeros do not substitute for observed safety results or establish the absence of complications.
The trial is described as non-randomized. In general, non-randomized comparisons can be affected by differences between the people receiving each method, including differences related to clinical decisions. Such differences can complicate interpretation even when outcomes are available. Here, the registry does not report enough information about assignment, participant characteristics, or outcome observations to evaluate those issues empirically.
No analyses are listed in the registry record. There is no reported effect estimate, confidence interval, hypothesis test, or analysis population for either endpoint. Statistical significance and precision therefore cannot be assessed. The absence of an estimated effect also means there is no observed effect on which to base a planning illustration that uses a fraction of the observed effect.
The information supports a description of the study’s question, design, endpoint definition, and termination, but not an effectiveness or safety conclusion. It does not show that contrast-enhanced guidance improves biopsy success, reduces complications, increases complications, or has no association with either outcome. The lack of results is not evidence for equivalence between the methods; it means the planned outcome comparison is unavailable in the registry record.
9. Statistical Methods Explained
The registry identifies the study as non-randomized and parallel, but does not report a statistical analysis plan. It lists no analyses and says that no outcome data were collected. The statistical concepts below are general explanations of how such a comparison could be interpreted if outcome observations and an analysis were available; they do not describe analyses completed for this study.
What would a group comparison estimate?
For a binary endpoint such as whether a participant experienced a defined complication, a basic comparison would describe the observed rate in each method group and estimate the difference or another contrast between those rates. Such an estimate summarizes the data collected; it does not by itself establish that the method caused the observed outcome. In a non-randomized study, factors associated with receiving a method and with the outcome can affect the comparison. Adjustment can sometimes address measured differences, but it cannot automatically remove bias from unmeasured factors. The registry record does not report an adjusted or unadjusted comparison.
How should uncertainty be described?
In general, a confidence interval gives a range of values compatible with the observed data under the assumptions of the statistical method. Its width reflects precision: a wider interval indicates less precise estimation, while a narrower interval indicates greater precision. A p-value, when used, describes how unusual the data would be under a specified null model; it is not the probability that the null hypothesis is true and does not measure the size or clinical importance of an effect. The registry reports no estimates, confidence intervals, or p-values for the study outcomes, so none of these features can be evaluated.
What does the composite endpoint involve?
The primary endpoint combines bleeding seen on post-biopsy CT or US, a hemoglobin drop of more than 1.5 g/dL within one week after biopsy, and the need for hepatic artery embolization. In general, a composite can capture different ways an outcome of interest may arise. Its overall rate can be difficult to interpret without knowing which components occurred, because a change in the composite could be driven by a component that differs in clinical importance or detection. Component-level counts and results are not reported in the registry record. The endpoint definition also does not, by itself, specify how overlapping criteria would be handled in an analysis.
Why does non-randomized allocation matter?
General statistical reasoning distinguishes association from causal effect. Random assignment, when used and implemented appropriately, can help balance both measured and unmeasured participant characteristics across groups. In a non-randomized comparison, group differences may remain. For example, clinical selection of a method could be related to patient features that also affect complication risk. Statistical adjustment may reduce confounding from recorded characteristics, but the registry record does not report whether adjustment was planned or performed, what covariates would be used, or whether the relevant characteristics were collected. No conclusion about the size or direction of possible bias can be drawn from the available record.
Can the record support a sample-size interpretation?
In general, sample-size planning depends on assumptions about the outcome, the effect considered important, variability or event frequency, allocation, and the chosen error and power targets. A planning calculation is not an observed result and does not show that a completed study had a particular probability of detecting an effect. The registry’s stated planning illustration is based on a fraction of the observed effect, but the record reports no outcome data and no observed effect. Accordingly, there is no outcome-based effect estimate in the registry record to anchor such an illustration. The record does not report the study’s own sample-size justification or design assumptions.
What analysis can be inferred?
None of the intended analysis details can be reconstructed from the endpoint definition or study design alone. The registry does not report a test choice, confidence-interval method, covariate adjustment, handling of missing observations, or a prespecified analysis population. It also does not report interim analyses. These details are not reported in the registry record, and should not be inferred from general practice or from the presence of a planned outcome.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists complication rate as the primary outcome and success rate as a secondary outcome. It does not report a multiplicity strategy, such as whether the interpretation of several outcomes would be adjusted to account for multiple statistical tests. Since no analyses or outcome data are reported, there are no outcome tests for which the consequences of multiplicity can be assessed. The record does not establish whether any analysis plan was finalized before termination.
The registry says that no data were collected for outcome measures. This is different from having collected outcome observations and then losing some records or leaving some values missing. The record does not describe participant-level outcome availability, reasons for missing observations, or procedures for handling missing data. It therefore cannot support an assessment of missingness patterns or the assumptions an analysis might make about them.
The analysis populations are not reported in the registry record. It does not say which participants, if any, would have been included in an intention-to-treat, per-protocol, or other analysis set. Although enrollment is listed as 83, the record does not establish how many participants received a biopsy, which method they received, or whether they contributed outcome observations. No denominator for an outcome rate is available.
These limitations prevent evaluation of how the investigators would have managed multiple endpoints, missing observations, or analysis-set definitions. They also mean that the listed zero adverse-event counts cannot be used to fill the gap: the record explicitly reports no outcome data collection.
11. What the Result Does, and Does Not, Mean
The registry record establishes that the investigators planned a non-randomized comparison of liver biopsy with prior Lumason contrast enhancement and biopsy without prior contrast enhancement. It identifies complication rate as the primary endpoint, defines the complication criteria, and lists success rate as a secondary outcome. It also records that the study was terminated after insufficient recruitment and an internal IRB audit.
It does not establish how either method performed. No complication or success results were collected for the outcome measures, and no analysis is listed. There is no reported estimate of the size or direction of a difference, and no uncertainty measure with which to judge precision. The adverse-event entries with zero counts do not demonstrate that complications were absent, given the explicit statement that no outcome data were collected.
The record therefore cannot support a conclusion that contrast-enhanced sonography changed complications or biopsy success. Nor does the absence of a reported difference show that the methods are equivalent. Equivalence or non-inferiority requires an appropriate design, prespecified criteria, and outcome estimates with adequate precision; none is reported.
More generally, a planned comparison and an observed result are distinct. A trial question can be scientifically relevant even when recruitment or other circumstances prevent outcome analysis. In this case, the registry is informative about the intended comparison and why the study did not produce reported outcome results, but it leaves the clinical and statistical questions unanswered.
12. Why This Trial Matters Statistically
This study illustrates an important distinction in clinical research: a registered comparison does not necessarily yield analyzable outcome evidence. The record describes a specific question about ultrasound guidance during liver biopsy and defines a composite complication endpoint, but it also states that no outcome data were collected. As a result, the design and endpoint can be discussed, while the treatment comparison itself cannot be estimated.
The case also highlights why enrollment figures need careful interpretation. The registry lists enrollment as 83, yet reports insufficient patient recruitment and no outcome data collection. Enrollment alone does not establish how many people received each method, had evaluable follow-up, or contributed to an endpoint analysis. Without outcome denominators and observations, rates and comparisons cannot be interpreted.
Non-randomized allocation adds another statistical consideration: even with outcomes, differences between groups could reflect differences in the participants or clinical decisions that led to use of each method. This does not make a non-randomized study uninformative by definition, but it makes transparent reporting of group characteristics, analytic choices, and uncertainty particularly important. Those details and an outcome analysis are absent from this record.
Finally, the record shows why zero entries in an adverse-event listing should be read in context. When the registry states that outcome data were not collected, zero counts cannot be treated as affirmative evidence of zero risk. The central statistical lesson is that endpoint definitions and design labels do not replace observed data and a clearly reported analysis.
13. 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 is that no outcome data were collected, as stated in the registry record. There are consequently no reported results for the primary complication endpoint or the secondary success outcome. The absence of outcome observations prevents estimation of rates, comparisons, and precision.
The study was terminated after insufficient patient recruitment and an internal IRB audit, according to the registry. It does not explain the details of recruitment, the audit, or how these events affected study conduct beyond termination and the absence of outcome data. Although enrollment is listed as 83, the record does not report how many participants received each biopsy method or completed follow-up.
The non-randomized design limits the ability to interpret any potential group difference as a causal effect. The record does not report how participants were assigned to methods, whether method choice depended on clinical characteristics, or what participant characteristics were collected. It also provides no analysis plan, adjustment strategy, or analysis populations.
The primary endpoint combines distinct criteria, but component-specific outcomes are not reported. The registry does not describe whether each component was intended to be analyzed separately or how overlapping criteria would be treated. The success-rate definition is also not reported. These gaps would matter for interpreting results even if aggregate outcome data were available.
Finally, the registry lists zero adverse-event counts while also stating that no outcome data were collected. Those entries cannot resolve the absence of safety outcomes. Overall, the record supports description of the intended study, but not an assessment of its clinical findings.
14. Related Tutorials
15. Related Statistical Calculators
16. Sources
- ClinicalTrials.gov: Prospective Analysis of Value of Contrast-enhanced Sonography During Biopsies of Focal Liver Masses — NCT03040323.
- Registry record last updated 2019-08-08; status last verified 2019-07.
- Results first posted 2019-07-24.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
17. Record Summary
The registry record describes a Phase 4, parallel, non-randomized study sponsored by Indiana University. It planned to compare liver biopsy preceded by Lumason 60.7Mg Powder for Injection with biopsy without prior contrast enhancement. The primary endpoint was complication rate over 30 days, using criteria based on bleeding, a hemoglobin drop of more than 1.5 g/dL within one week, or hepatic artery embolization. Success rate was listed as a secondary outcome.
The record lists enrollment as 83, a start date of 2016-12-22, and a primary completion date of 2018-06-30. Study status is terminated. The registry attributes termination to insufficient recruitment and an internal IRB audit and states that no data were collected for outcome measures. No analyses or outcome results are reported, so the intended comparison cannot be estimated from this record.