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 MRCP: A Reliable, Non Invasive Method for Staging Chronic Pancreatitis in Pediatrics (NCT02869893), a na na study. The primary outcome is Total Secreted Fluid Volume as Measured by MR-PFT.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02869893 |
| Phase | NA |
| Condition | Healthy Volunteers |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 57 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Children's Hospital Medical Center, Cincinnati |
| Results posted | Yes |
2. Clinical Question
Population
The study enrolled healthy participants. The registry lists “Healthy Volunteers” as the condition and gives an enrollment of 57. Although the trial title refers to staging chronic pancreatitis in pediatrics, the described study population is healthy participants; the record does not report results in children with chronic pancreatitis.
Intervention
All participants underwent MRCP with secretin and MR elastography. Secretin was administered during the imaging procedure to stimulate pancreatic fluid release. MRCP was used to image fluid, while MR elastography was used to assess pancreatic stiffness.
Comparator
There was no separate comparator group. The record describes a single-group study, with the same participants imaged before and after secretin administration. Pre-secretin imaging served as the reference for measuring the change in enteric fluid volume; it was not a randomized control arm.
Primary question
The primary endpoint was total secreted fluid volume measured by MR-PFT. The study aimed to characterize the fluid-volume response to secretin among healthy participants, alongside measurements of pancreatic stiffness and pancreatic parenchymal volume. The endpoint result itself is not reported in the registry record.
3. Trial Design
This completed study is registered as a single-group, non-randomized study with no masking. The registry reports enrollment of 57 healthy participants and lists Secretin as the intervention. All participants were assigned to the Healthy Participants group and underwent MRCP with secretin and MR elastography. The record does not describe a separate untreated, placebo, or active-comparator group.
The study began on 2016-08-10, and the primary completion date is 2017-04-06. The sponsor is Children's Hospital Medical Center, Cincinnati. The phase is listed as NA, and the study kind is listed as other. The record does not report a protocol-level allocation procedure or a statistical analysis plan.
Imaging was performed before and after secretin administration. The primary endpoint description specifies approximately 20 minutes of pre-secretin imaging and 15 minutes of post-secretin imaging, for a 35-minute timeframe. Post-secretin images were acquired at 1 minute, 5 minutes, and 15 minutes after completion of the injection. The investigators used the pre-secretin fluid volume as a baseline and subtracted it from the post-secretin volume at each time point.
The study also lists pancreatic stiffness measured by MR elastography and volumetric measurement of pancreatic parenchymal volume as secondary outcomes. Although three outcome measures are recorded, the registry lists zero analyses. The numerical outcome results, analysis populations, and explanation of how enrollment related to the number included in each analysis 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 | Healthy Participants |
|---|---|
| STARTED | 57 |
| COMPLETED | 50 |
| NOT COMPLETED | 7 |
Reasons for not completing this period:
| Reason | Healthy Participants |
|---|---|
| participant aversion to IV | 5 |
| participant fear of MRI scanner | 2 |
Analysis population for the primary outcome, as defined in the registry: Healthy participants
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.
| Characteristic | Unit | Healthy Participants |
|---|---|---|
| Participants analysed | 50 | |
| Age, Customized: 6-11 years | Participants | 27 |
| Age, Customized: 12-16 years | Participants | 23 |
| Sex: Female, Male: Female | Participants | 27 |
| Sex: Female, Male: Male | Participants | 23 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 50 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 15 |
| Race (NIH/OMB): White | Participants | 33 |
| Race (NIH/OMB): More than one race | Participants | 1 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 1 |
6. Primary Endpoint
The registry lists the primary outcome as Total Secreted Fluid Volume as Measured by MR-PFT, measured over 35 minutes (20 min pre-secretin, 15 minutes post-secretin).
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | Full Range |
| Unit | mL |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is total secreted fluid volume measured by MR-PFT, in mL. It is intended to quantify the change in enteric fluid volume associated with secretin administration. Participants had MR imaging before and after secretin; the pre-secretin fluid volume was subtracted from the post-secretin volume for each participant and time point. Images after secretin were acquired at 1 minute, 5 minutes, and 15 minutes following completion of the injection.
The described imaging approach uses commercially available software to identify fluid signal on MR images. Subtracting the pre-secretin signal from each post-secretin image is intended to separate the stimulated fluid response from fluid already present before secretin. This is a measurement strategy, not a comparison between separately assigned groups.
The registry identifies the endpoint summary as a median with full range and gives a timeframe of 35 minutes, including approximately 20 minutes before secretin and 15 minutes afterward. A median describes the central observation after ordering participant values; the full range describes the smallest and largest observations. These summaries can convey the center and spread of measurements, but the range can be strongly affected by extreme observations.
The actual median, range, and any time-specific endpoint results are not reported in the registry record. Therefore, the endpoint definition can be described, but the observed fluid-volume response cannot be quantified from the recorded results.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record defines a study of secretin-stimulated imaging in healthy participants, not a randomized comparison of treatments. All participants underwent the imaging procedure, and pre-secretin measurements were used as the reference for post-secretin fluid volumes. This within-participant measurement structure can describe change across the imaging procedure, but without a separate comparator group it cannot by itself distinguish the secretin-associated response from every other influence that might affect measurements over time.
The primary endpoint is specified as a median and full range, but its numerical result is not reported in the registry record. No estimate of the typical measured volume, the spread of participant measurements, or the differences among post-secretin time points can therefore be stated. The registry also does not report numerical results for pancreatic stiffness or pancreatic parenchymal volume. The study's stated measurement goals should not be mistaken for findings.
The registry reports enrollment of 57, while the adverse-event record lists 50 participants at risk in its categories. The record does not explain this difference or report how many participants contributed data to each endpoint analysis. Enrollment should therefore not automatically be treated as the denominator for every outcome or safety summary.
The record lists three outcome measures and zero analyses. It gives no reported confidence intervals, p-values, or other inferential results. A confidence interval, as a general statistical concept, represents uncertainty around an estimated quantity under a specified method; without an estimate and interval, the precision of this study's endpoint cannot be assessed. The absence of a reported interval is not evidence that the estimate was precise or imprecise.
Any sample-size figures intended for planning should be read as hypothetical planning illustrations, not as observed power or as evidence about the endpoint's precision. The study is described as single-group, whereas the planning assumptions refer to equal allocation between two arms. Such assumptions do not describe the allocation used in this study. No conclusion about a treatment effect or diagnostic performance can be drawn from the endpoint definition alone.
9. Statistical Methods Explained
What does the study design allow?
In a single-group design, participants follow the same study procedure rather than being assigned to separate comparison groups. Here, participants underwent imaging before and after secretin. The paired measurements provide a way to describe within-participant changes across the procedure. In general, paired measurements can account for stable differences between participants because each person's baseline is compared with that person's later measurement. They do not, on their own, establish that secretin caused every observed change: time, measurement conditions, or other factors may also contribute.
The registry lists allocation as NA and masking as none. It does not describe random assignment or blinding. With no separate comparator group, the study is best understood as a measurement study in healthy participants, rather than a randomized trial comparing alternative interventions. The registry does not report a protocol or analysis plan that would clarify additional design details.
How is the primary measurement formed?
The primary endpoint is total secreted fluid volume measured by MR-PFT. The record describes imaging before secretin and imaging after secretin, with post-secretin images at 1 minute, 5 minutes, and 15 minutes after the injection is complete. Pre-secretin enteric fluid volume is subtracted from the corresponding post-secretin volume for each participant. In general, baseline subtraction aims to focus the measurement on the change from the pre-stimulation state. It also means that error in either measurement may affect the resulting change score.
The endpoint is reported in mL and is designated as a median with full range. A median is the middle value when observations are ordered, and it is often useful when measurements are skewed or include extreme values. The full range gives the lowest and highest observed values, but it does not show how observations are distributed between those endpoints. In general, a range can be sensitive to unusually small or large values. The numerical median and range are not reported in the registry record, so the distribution and precision of the observed measurements cannot be evaluated.
What do the time points mean?
The endpoint description distinguishes pre-secretin imaging from post-secretin imaging. The post-secretin observations at 1 minute, 5 minutes, and 15 minutes allow the measurement procedure to capture fluid signal at different times after stimulation. The record does not report numerical results for these time points or specify a separate inferential comparison among them. No time trend, peak response, or rate of change should be inferred from the timing description alone.
How should uncertainty be understood?
In general, an estimate describes the quantity calculated from the observed participants, while a confidence interval communicates uncertainty about that estimate under the assumptions of the chosen method. A wider interval usually indicates less precision, and a narrower interval usually indicates greater precision; neither width can be assessed without the actual interval and estimate. The registry does not report confidence intervals, standard errors, p-values, or other inferential statistics for the primary outcome.
The record specifies a median and full range, rather than a mean and standard deviation, as the primary summary. Those statistics describe different aspects of a distribution. A mean uses all measured values and can be influenced by extremes, while a median represents the central ordered observation. The range reports only the endpoints of the observed values and does not supply the same information as a standard deviation or an interval estimate. No distributional assumptions or method for uncertainty estimation are reported in the registry record.
What about sample-size planning?
General sample-size calculations estimate the number of participants or events that might be needed to detect a specified effect under stated assumptions. A planning illustration is not an observed result and is not observed power. The planning assumptions associated with this record describe a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. They describe a hypothetical two-arm planning framework, not the single-group design recorded for this study. No numerical planning estimates or sample-size justification from the study protocol are reported in the registry record.
What can be concluded from the available statistical reporting?
The record describes the endpoint construction and its summary type but does not provide the outcome values or statistical analyses. Accordingly, it supports an account of what was intended to be measured, but not an estimate of the measured response or its precision. The result cannot be reconstructed from the enrollment count or from the outcome definitions.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists three outcome measures: the primary fluid-volume endpoint and secondary measures of pancreatic stiffness and pancreatic parenchymal volume. Considering several outcomes can raise a multiplicity question because repeated statistical testing may increase the chance of at least one apparently notable result. In general, an analysis plan may address this through a hierarchy of outcomes, an adjustment procedure, or a clearly exploratory interpretation. The registry record does not report a multiplicity strategy, and it lists zero analyses.
Missing-data handling is not reported in the registry record. The record does not state whether any participants had incomplete imaging, how incomplete measurements were treated, or whether an imputation method was used. It also does not report an analysis population definition, such as which participants were included in each endpoint analysis. These omissions matter because the number enrolled need not equal the number with an evaluable measurement.
The registry reports enrollment of 57, while the safety information lists 50 participants at risk. It does not explain the difference. The record also does not state the number of participants contributing to the primary endpoint or secondary outcomes. Consequently, the denominators for efficacy or measurement analyses cannot be inferred from enrollment or the safety counts.
There is no reported statistical analysis plan, no stated handling of repeated measurements across the post-secretin time points, and no reported method for estimating uncertainty. These are not evidence that a particular method was or was not used outside the registry record; the methods are simply not reported in the registry record.
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 |
|---|---|---|---|
| Healthy Participants | 0 | 50 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Healthy Participants | 0 of 50 |
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 |
|---|---|
| Healthy Participants | 1 of 50 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Healthy Participants |
|---|---|---|
| Nausea | Gastrointestinal disorders | 1 of 50 |
The registry's adverse-event record lists 50 healthy participants at risk for serious adverse events and 0 participants affected. It also lists 50 participants at risk for other adverse events and 1 participant affected. The death count is 0. No serious adverse-event terms are listed.
These are reported counts, not estimates of risk for other populations or settings. The record does not identify the non-serious event, describe its severity or timing, or explain whether it was considered related to secretin, imaging, or another study procedure. The category “other adverse events” should therefore not be interpreted as a specific event type.
The safety denominator of 50 differs from the enrollment of 57. The registry does not explain the difference or report whether all enrolled participants underwent the same safety follow-up. The counts should be read using the stated at-risk denominator rather than treating enrollment as the denominator. Zero reported serious events means none were recorded in the listed category for the participants at risk; it does not establish that no adverse event could occur beyond this study or in another population.
12. What the Result Does, and Does Not, Mean
This registry record describes a completed imaging study in healthy participants. Its primary measurement was the volume of fluid signal after secretin, assessed relative to the pre-secretin measurement. It also identifies pancreatic stiffness and pancreatic parenchymal volume as secondary measurement aims. These details explain what the investigators set out to measure, but the registry does not report the numerical outcome findings.
Because no endpoint values are reported, the record does not establish the typical measured fluid volume, the variability among participants, or how the measurements changed across the post-secretin time points. It also provides no numerical results for stiffness or pancreatic volume. No confidence intervals or inferential results are recorded, so the precision of the findings cannot be evaluated. A stated outcome and timeframe are not substitutes for an observed result.
The single-group structure also limits interpretation. Pre-secretin measurements provide an internal reference for post-secretin observations, but there is no separate control group described. The record therefore does not provide a randomized comparison or a basis for attributing all observed changes to secretin. It does not report diagnostic accuracy, comparisons between healthy participants and people with chronic pancreatitis, or evidence about staging chronic pancreatitis in patients.
The title refers to staging chronic pancreatitis in pediatrics, but the described population is healthy participants. The record does not report disease-group findings. Nor does the enrollment figure indicate how many participants contributed usable data to each endpoint analysis; analysis populations are not reported.
In general, a measurement study can contribute information about how imaging procedures quantify a biological signal. Whether such measurements distinguish clinical groups or support clinical decisions requires appropriate results and validation evidence. Neither can be assessed from the endpoint definitions alone. The registry record supports a description of the study procedures and the intended measurements, but not a conclusion about the size, reliability, or clinical usefulness of the measured response.
13. Why This Trial Matters Statistically
This study is statistically notable for its within-participant measurement structure. Rather than comparing separate treatment groups, it measures fluid signal before and after secretin in the same participants. In general, repeated measurements can help characterize how an imaging signal changes over a procedure and can reduce the influence of stable differences among participants. They also require clarity about how observations at different times are summarized and analyzed.
The endpoint is explicitly defined through pre-secretin subtraction, and the imaging schedule names three post-secretin time points. These details make the measurement target more interpretable than a broad outcome label alone. The use of a median and full range also identifies the intended descriptive summary. However, without the recorded values, the extent of between-participant variation and the behavior of the measurement cannot be assessed.
The record additionally illustrates why design and planning assumptions must be kept distinct. The study is single-group, while the planning assumptions refer to equal allocation between two arms. A hypothetical two-arm sample-size illustration does not describe the study's actual allocation and cannot be treated as observed power. The registry does not report a protocol-based sample-size justification.
Finally, the difference between enrollment and the safety denominator, together with the absence of endpoint analysis counts, highlights the importance of reporting analysis populations and missing-data handling. Those details help readers understand which participants support each result. The record does not report them, nor does it provide the primary endpoint result. Statistically, the study's value in this record is therefore clearest in its measurement design and endpoint definition, while the magnitude and precision of its findings remain unavailable.
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 most consequential limitation for interpreting the results is that numerical primary and secondary outcome findings are not reported in the registry record. The primary endpoint is defined, but no median or full range is given. The record also contains no confidence intervals, p-values, or other inferential statistics. Thus, neither the size nor the precision of the measured response can be evaluated.
The population is described as healthy participants, despite a title referring to staging chronic pancreatitis in pediatrics. The record does not provide results from participants with chronic pancreatitis or a comparison between healthy participants and a disease group. It therefore does not establish performance for staging the disease.
The design is single-group and unmasked, with no separate comparator group. The pre-secretin measurement is an internal reference, not an independent control arm. This structure can describe measurements over the imaging procedure but cannot provide a randomized between-group comparison. The registry does not report a statistical analysis plan or explain how repeated measurements were analyzed.
Enrollment is listed as 57, but the adverse-event record gives 50 participants at risk, and the number included in endpoint analyses is not reported. The record does not explain the safety denominator or describe missing data, exclusions, or analysis populations. It also does not report a multiplicity approach for the three outcome measures. These reporting gaps limit assessment of completeness, uncertainty, and the interpretation of multiple outcomes.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: MRCP: A Reliable, Non Invasive Method for Staging Chronic Pancreatitis in Pediatrics — NCT02869893.
- Registry record last updated 2020-08-07; status last verified 2020-07.
- Results first posted 2020-08-07.
- 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
NCT02869893 is a completed, single-group study sponsored by Children's Hospital Medical Center, Cincinnati. It enrolled 57 healthy participants and evaluated MRCP with secretin and MR elastography. The primary endpoint was total secreted fluid volume measured by MR-PFT, summarized in the registry as a median with full range. The endpoint description uses pre-secretin fluid volume as a baseline and specifies post-secretin imaging at 1 minute, 5 minutes, and 15 minutes.
Secondary outcomes were pancreatic stiffness measured by MR elastography and pancreatic parenchymal volume. The registry lists three outcome measures and zero analyses. Numerical endpoint findings, analysis populations, missing-data methods, and a statistical analysis plan are not reported in the registry record. The safety record lists 0 serious adverse events among 50 participants at risk, 1 participant with another adverse event among 50 at risk, and 0 deaths. It does not explain why the safety denominator differs from enrollment.