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 Incorporating Endoscopic Ultrasound and Elastography Towards Improving Outcomes of Pediatric Pancreatitis Management (NCT06068426), a na na study. The primary outcome is EUS Pancreatic Findings- Rosemont Criteria.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT06068426 |
| Phase | NA |
| Condition | Chronic Pancreatitis, Acute Recurrent Pancreatitis |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 66 |
| Arms in the primary outcome | n/a |
| Lead sponsor | David Vitale MD |
| Results posted | Yes |
2. Clinical Question
Population
Children with confirmed acute recurrent pancreatitis or chronic pancreatitis, alongside controls without a history of pancreatic disease. The record lists enrollment of 66 participants.
Intervention
Transabdominal ultrasound shear wave elastography (TUS SWE), a method intended to assess pancreatic tissue stiffness. The study description also discusses EUS SWE and EUS evaluation.
Comparator
Children without a history of pancreatic disease formed a control cohort. This was not a randomized, like-for-like treatment comparison.
Primary question
What pancreatic findings, classified using EUS Rosemont Criteria, were observed at the time of EUS? The registry lists the endpoint as a percentage of participants but does not report the endpoint results.
The research addresses a diagnostic and measurement question in pediatric pancreatitis. The study description notes that childhood pancreatitis has been studied less extensively than adult disease, and that diagnostic and treatment approaches have often drawn on adult studies. It describes EUS as a tool for assessing pancreatic disease and shear wave elastography as a way to measure fibrosis, or scarring. The study planned to use information from EUS SWE and TUS SWE to improve understanding of pancreatitis in children.
The registered primary outcome is EUS pancreatic findings according to Rosemont Criteria, assessed at the time of the EUS procedure. The criteria include major and minor features such as hyperechoic foci, lobularity, cysts, stranding, and pancreatic duct findings. The record does not give counts or percentages for these features or for Rosemont classifications. It therefore does not permit a numerical answer about how frequently particular findings occurred.
3. Trial Design
The registry describes a completed, single-group study with enrollment of 66. It lists allocation as not applicable and masking as none. The study included two cohorts: children with confirmed acute recurrent pancreatitis or chronic pancreatitis, and controls without a history of pancreatic disease. Because participants were not randomized to the two cohorts, their contrast is observational rather than a randomized comparison of treatment effects.
The listed intervention is transabdominal ultrasound shear wave elastography, categorized as a diagnostic test. The study description also discusses EUS and shear wave elastography performed with EUS and transabdominal ultrasound systems. These are assessment methods, not therapies assigned to improve a clinical outcome. The main research aim was to learn more about pancreatitis in children and to evaluate ultrasound-based information relevant to pancreatic disease.
The registry lists a start date of 2021-09-13, a primary completion date of 2023-08-04, and a completed status. The sponsor is David Vitale MD. Phase is listed as NA. The record lists 20 outcome measures and zero analysis entries.
For the primary endpoint, the record states that one test subject was excluded because active acute pancreatitis was found at the time of EUS. The stated reason is that acute pancreatitis can interfere with evaluation of EUS findings related to chronic pancreatitis. The record does not describe a broader analysis-population definition or say how this exclusion affected the denominator for each outcome.
The two cohorts can help describe findings in children with and without a history of pancreatic disease. Without random assignment, however, cohort differences may reflect underlying differences between participants as well as differences in pancreatic findings. The registry record does not report a protocol-level statistical plan, a sample-size justification, or details of the recruitment and measurement procedures beyond the study description.
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 | Children With Confirmed Diagnosis of ARP or CP | Controls (Children Without a History of Pancreatic Disease) |
|---|---|---|
| STARTED | 45 | 21 |
| COMPLETED | 39 | 20 |
| NOT COMPLETED | 6 | 1 |
Analysis population for the primary outcome, as defined in the registry: one test subject was excluded from the analysis because of unexpected findings of active acute pancreatitis at the time of the endoscopic ultrasound (EUS). This exclusion was necessary because acute pancreatitis can interfere with the evaluation of EUS findings related to chronic pancreatitis (CP) and acute recurrent pancreatitis (ARP).
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: 45 subjects with ARP/CP were enrolled but only 39 completed the study. 21 controls were enrolled but only 20 completed the study. These 7 subjects were excluded from analysis.
| Characteristic | Unit | Children With Confirmed Diagnosis of ARP or CP | Controls (Children Without a History of Pancreatic Disease) | Total |
|---|---|---|---|---|
| Participants analysed | 39 | 20 | 59 | |
| Age, Continuous | years | 12.13 (6 to 19) | 15.1 (6 to 20) | 13.12 (6 to 20) |
| Sex: Female, Male: Female | Participants | 19 | 9 | 28 |
| Sex: Female, Male: Male | Participants | 20 | 11 | 31 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 5 | 0 | 5 |
| Race (NIH/OMB): White | Participants | 32 | 19 | 51 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 2 | 1 | 3 |
| Region of Enrollment: United States | Participants | 39 | 20 | 59 |
6. Primary Endpoint
The registry lists the primary outcome as EUS Pancreatic Findings- Rosemont Criteria, measured over At time of EUS procedure.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | percentage of participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is titled EUS Pancreatic Findings—Rosemont Criteria. It is expressed as the percentage of participants and is assessed at the time of the EUS procedure. The listed features include major criteria, such as hyperechoic foci with shadowing and lobularity with honeycombing, and minor criteria, such as cysts, stranding, and pancreatic duct features. The registry also lists Rosemont classifications among the secondary outcomes.
In general, a structured set of criteria provides a consistent way to describe observed findings. Categorizing pancreatic features can help characterize the pattern of EUS findings in the study population. This endpoint is descriptive: it records findings at an examination, rather than measuring change caused by an assigned treatment.
The registry record does not report the number of participants with each feature, a percentage for any feature, or a summary classification result. It also does not give an estimate of precision, such as a confidence interval. Consequently, the endpoint definition is available, but its numerical findings cannot be interpreted from the registry information. The record notes that one participant was excluded from the primary analysis because active acute pancreatitis at EUS could interfere with evaluation of findings related to chronic pancreatitis.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The record describes a pediatric diagnostic study with a pancreatitis cohort and a control cohort. Its central statistical purpose is to characterize EUS pancreatic findings using Rosemont Criteria and to study ultrasound-based measures in children. It is not a randomized comparison of treatments. The cohort structure can support descriptive comparisons, but it cannot by itself establish that a diagnostic method caused a difference in findings or outcomes.
The record does not report numerical results for the primary endpoint. Although the endpoint is defined as a percentage of participants and the relevant features are listed, there are no feature counts, percentages, effect estimates, confidence intervals, or p-values in the registry entries. The record therefore does not establish the frequency of any Rosemont feature or the degree of statistical uncertainty around such a frequency.
The study reports enrollment of 66 across the two cohorts. The adverse-event figures list 45 children with confirmed ARP or CP and 21 controls at risk. These figures describe the safety-group denominators, not the primary endpoint results. The primary-outcome population is also affected by the stated exclusion of one participant with active acute pancreatitis at EUS; the record does not specify the resulting denominator for each primary measure.
Because allocation is listed as not applicable and the study is single-group, the cohorts should not be read as randomized arms. Children with pancreatitis and children without a history of pancreatic disease differ by the condition that defines their cohort. Any observed difference could reflect that cohort distinction or other factors; the record does not give adjusted comparisons that would help separate these explanations.
The record lists 20 outcome measures but zero analysis entries. This means the registry information does not contain posted analysis results to assess. It does not establish that no analyses were conducted outside the registry. No inference about the size, precision, or statistical significance of the primary endpoint is possible from the endpoint definition alone.
The study description gives a rationale for examining elastography in children, noting that the techniques had been studied for chronic pancreatitis in adults but not in children. That rationale explains the research question; it is not evidence that the methods performed accurately or that they changed care. Numerical diagnostic-performance results, such as agreement or classification accuracy, are not reported in the registry record.
9. Statistical Methods Explained
What does a percentage endpoint describe?
In general, a percentage expresses the share of an analysis population meeting a stated definition. For a diagnostic finding, the definition might be the presence of a particular feature or classification. To interpret a percentage, readers need both the number meeting the definition and the relevant denominator. The registry describes the primary endpoint as a percentage of participants but does not report its counts or percentages. The exclusion of one participant from the primary analysis also makes the precise analysis denominator important, but that denominator is not stated for the endpoint.
A percentage is descriptive unless it is paired with a comparison and a clearly defined inferential analysis. It can summarize how often a finding appeared in the participants assessed, but it does not by itself show that a test caused the finding or that the finding predicts a later outcome. In this study, Rosemont features are recorded at the EUS procedure, so the endpoint concerns observed pancreatic findings at that assessment.
What is a confidence interval?
In general, a confidence interval describes the statistical uncertainty around an estimate under a specified method and its assumptions. A narrower interval indicates greater precision under those assumptions; a wider interval indicates more uncertainty. An interval does not remove limitations in the design, measurement, or representativeness of the participants. No confidence interval for the primary endpoint is reported in the registry information.
When comparing two groups, an interval around a difference can show which values are compatible with the data under the analysis method. But the clinical meaning of an interval depends on the outcome definition, the population, and the design. Because this study was not randomized, any cohort comparison would remain observational even if an interval or p-value were available. The registry record does not provide a comparative estimate for the primary endpoint.
What does the cohort structure imply?
The two cohorts were defined by disease history: children with confirmed ARP or CP, and controls without a history of pancreatic disease. In general, a comparison between such cohorts can describe how measured findings differ across those groups. It cannot automatically attribute differences to a test or intervention. Randomization is used in some trials to balance participant characteristics across assigned groups; allocation is listed as not applicable in this study, so that design protection does not apply.
Adjustment for relevant participant characteristics can sometimes address measured differences in observational comparisons. It cannot guarantee control of unmeasured differences. The registry record does not report an adjusted analysis or specify which variables, if any, were considered in an analysis model. No model-based conclusions should therefore be inferred from the cohort descriptions alone.
What can be learned from missing numerical results?
The endpoint title, unit, timing, and feature definitions explain what the researchers intended to measure. They do not supply the observed results. Without counts or estimates, there is no basis for judging the frequency of findings, the precision of estimates, or whether the pancreatitis and control cohorts differed statistically. A listed endpoint is not itself evidence of a positive or negative finding.
The registry lists 20 outcome measures and zero analysis entries. In general, many outcomes can create a multiplicity issue if several statistical tests are conducted, because the chance of at least one apparently unusual result can increase as the number of tests grows. Strategies such as prespecifying a primary outcome or adjusting inference may address that concern, depending on the analysis plan. The registry information does not report whether any multiplicity strategy was planned or used. The number of outcome measures alone does not show that testing occurred or that any result was statistically significant.
How should planning calculations be read?
In general, power calculations are planning tools based on assumptions about the effect to detect, variability, analysis method, and error rates. They are not estimates of what the study actually observed. A sample-size illustration based on an observed effect is also not the trial's original design justification and should not be described as observed power. The registry record does not report a sample-size justification for the study. Any planning illustration should therefore be kept separate from the evidence about endpoint findings, particularly because numerical endpoint results are not reported.
Why can over-dispersion matter?
In general, over-dispersion occurs when observed variability is greater than a statistical model assumes. If a model underestimates variability, standard errors and confidence intervals may be too small, making results appear more precise than warranted. It is relevant to some kinds of count data, but the primary endpoint is a percentage of participants, and the registry does not describe a count model or an over-dispersion assessment. It would not be appropriate to claim that over-dispersion was present or that a particular model was used.
Overall, the available registry information supports a description of the intended endpoint and study design, but not a reconstruction of the statistical analysis. The analysis method, handling of missing values, adjustment strategy, and numerical uncertainty estimates are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 20 outcome measures, including calculated BMI, diagnoses and complications related to pancreatitis, and EUS Rosemont classifications. It records zero analysis entries. These registry entries do not show which outcomes were analyzed, how many statistical tests were performed, or whether any adjustment for multiple comparisons was planned. A multiplicity strategy is not reported in the registry record.
In general, when researchers test many outcomes, the chance of at least one apparently noteworthy result can increase. Prespecifying a primary endpoint and defining how secondary outcomes will be interpreted can help readers distinguish confirmatory questions from exploratory ones. The record identifies a primary endpoint, but it does not describe a statistical plan for the secondary outcomes or any multiplicity adjustment.
The record states that one participant was excluded from the primary analysis because active acute pancreatitis at EUS could interfere with evaluation of chronic pancreatitis findings. This is a specific exclusion rationale. The record does not explain how missing measurements were handled, whether other participants had incomplete data, or whether sensitivity analyses were conducted. It also does not report a complete analysis-population definition for each outcome.
Accordingly, the effect of missing or excluded observations on the endpoint estimates cannot be assessed. The stated exclusion should be kept distinct from missing-data handling: the record explains why that participant was excluded, but does not provide enough information to characterize data completeness or the analysis population for all outcomes.
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 |
|---|---|---|---|
| Children With Confirmed Diagnosis of ARP or CP | 0 | 45 | 0.0% |
| Controls (Children Without a History of Pancreatic Disease) | 0 | 21 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Children With Confirmed Diagnosis of ARP or CP | 0 of 45 |
| Controls (Children Without a History of Pancreatic Disease) | 0 of 21 |
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 |
|---|---|
| Children With Confirmed Diagnosis of ARP or CP | 0 of 45 |
| Controls (Children Without a History of Pancreatic Disease) | 0 of 21 |
The registry safety figures list 45 children with confirmed ARP or CP and 21 controls at risk. In each cohort, the record lists zero serious events, zero other events, and zero deaths. These are the posted safety counts for the groups and should be read as recorded figures rather than as proof that no event of any kind occurred outside the recorded reporting framework.
In general, an event count is most interpretable alongside its definition, observation period, collection procedures, and completeness of reporting. The safety information does not provide event definitions, details of surveillance, or a narrative of how events were collected. The record lists the study as a diagnostic test study and does not give an assigned treatment comparison for safety.
Zero recorded events does not establish that a procedure or assessment has no risk. It means that the registry lists no serious events, other events, or deaths in these groups. The record does not provide a comparison capable of estimating a relative safety effect between randomized treatment arms.
12. What the Result Does, and Does Not, Mean
The registry record documents a completed study intended to improve understanding of pediatric pancreatitis and ultrasound-based assessment. It defines an EUS primary endpoint based on Rosemont Criteria and describes cohorts with confirmed ARP or CP and controls without a history of pancreatic disease. These details clarify the research question and the population structure.
The record does not report numerical findings for the primary endpoint. It therefore cannot show how often the listed EUS features occurred, how the cohorts compared on those features, or how precise any estimate was. The stated exclusion of one participant with active acute pancreatitis at EUS is relevant to interpretation, but the remaining endpoint denominator and any sensitivity analysis are not reported.
The study is single-group, with allocation listed as not applicable. The two cohorts are not randomized treatment arms, and the registered diagnostic assessment should not be interpreted as a therapeutic intervention. Even if cohort differences were reported, they would describe an observational contrast and would not, on their own, establish a causal effect.
The registry's rationale is that pediatric pancreatitis has received less study than adult disease and that elastography techniques had not been studied in children. That makes the topic relevant to measurement research. It does not establish diagnostic accuracy, clinical benefit, or a change in management. The record does not report numerical evidence for those outcomes.
The safety figures record zero serious events, zero other events, and zero deaths in both listed cohorts. They do not establish an absence of all possible harms or quantify risk under a comparison design. Overall, the record identifies what investigators set out to measure, but the absence of posted numerical outcome analyses prevents conclusions about the observed diagnostic findings or their statistical precision.
13. Why This Trial Matters Statistically
Clinical measurement methods need evidence in the populations where they are intended to be used. The study focuses on children, a population the registry describes as under-studied in pancreatitis research compared with adults. It addresses whether EUS and ultrasound elastography can contribute information about pancreatic disease in this setting. That focus is statistically important because measurement performance and observed disease patterns should not simply be assumed to match across populations.
The study also illustrates the distinction between a diagnostic assessment and a treatment comparison. TUS SWE is listed as a diagnostic test, while the primary endpoint concerns EUS findings at a procedure. The two cohorts are defined by disease history rather than random assignment. Statistical interpretation must therefore center on description and measurement, not causal claims about treatment.
Transparent reporting of endpoint counts, denominators, and uncertainty is essential for assessing whether observed patterns are stable and how well they might generalize. Here, the endpoint definition and a participant exclusion rationale are recorded, but numerical primary results are not. The absence of those results limits what clinicians and researchers can learn about the frequency and precision of pediatric EUS findings from this record.
The registry lists multiple outcomes, making clear analysis planning and transparent reporting relevant. Without a posted analysis plan or outcome estimates, it is not possible to assess how the primary and secondary questions were handled statistically. The study's design and rationale are informative, but they do not substitute for reported 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 main limitation of the registry information is the absence of numerical primary-outcome results. No counts, percentages, effect estimates, confidence intervals, or p-values are reported for EUS Rosemont findings. This prevents assessment of both the observed patterns and their precision.
The study's two cohorts are not randomized comparison groups. Children with confirmed ARP or CP are compared structurally with controls without a history of pancreatic disease, so underlying cohort differences may affect observed findings. The registry does not report adjusted comparisons or the variables used in any such analysis.
The record states that one participant was excluded from the primary analysis because of active acute pancreatitis at EUS. It does not report the resulting primary-endpoint denominator or explain how other incomplete observations, if any, were handled. A complete analysis-population definition is not reported in the registry record.
The registry lists 20 outcome measures but zero analysis entries. It does not describe a statistical analysis plan, missing-data methods, multiplicity handling, or a sample-size justification. As a result, the intended and implemented statistical procedures cannot be evaluated from the record.
The safety figures are limited to the recorded group counts and do not include additional details about event definitions or surveillance. The study description gives a rationale for examining elastography in children, but numerical diagnostic-performance findings are not reported. These limitations constrain interpretation to the study's stated aims, design, and posted safety counts.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Incorporating Endoscopic Ultrasound and Elastography Towards Improving Outcomes of Pediatric Pancreatitis Management — NCT06068426.
- Registry record last updated 2025-07-15; status last verified 2025-06.
- Results first posted 2025-07-15.
- 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
The registry record describes NCT06068426, a completed, single-group pediatric study of pancreatitis with enrollment of 66. It includes children with confirmed ARP or CP and controls without a history of pancreatic disease. Allocation is listed as NA and masking as none. The listed diagnostic test is transabdominal ultrasound shear wave elastography.
The primary endpoint is EUS pancreatic findings according to Rosemont Criteria, expressed as a percentage of participants at the time of EUS. One participant was excluded from the primary analysis because active acute pancreatitis could interfere with evaluation of findings related to chronic pancreatitis. Numerical primary endpoint results are not reported in the registry record.
The record lists 20 outcome measures and zero analysis entries. Safety figures list zero serious events, zero other events, and zero deaths in both cohorts. The record does not report a statistical plan, missing-data approach, multiplicity strategy, or sample-size justification.