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 Capsule Endoscopy in Inflammatory Bowel Disease (IBD) in Children (NCT02182947), a na na study. The primary outcome is Diagnostic Yield of Magnetic Resonance Enterography (MRE).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02182947 |
| Phase | NA |
| Condition | IBD |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 45 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Children's Mercy Hospital Kansas City |
| Results posted | Yes |
2. Clinical Question
Population
Children with known inflammatory bowel disease (IBD), including Crohn's disease or indeterminate colitis. The registry record lists an enrollment of 45; it does not report how many participants contributed data to each outcome.
Intervention
Wireless capsule endoscopy (WCE), a capsule-based imaging approach. The study describes WCE findings in relation to magnetic resonance enterography findings in the same group of patients.
Comparator
Magnetic resonance enterography (MRE). This is a within-group diagnostic comparison, not a randomized comparison between separate treatment groups.
Primary question
What percentage of MRE studies are positive under the study's radiological criteria? The broader study question is whether WCE is superior or complementary to MRE when evaluating suspected disease exacerbation in children with known IBD. The primary endpoint, however, is MRE diagnostic yield rather than a reported direct estimate of superiority.
3. Trial Design
The registry record describes a completed, prospective study of diagnostic imaging in children with known IBD. Its summary frames the study as an assessment of MRE and WCE for identifying suspected disease exacerbation, rather than for making an initial diagnosis in children whose IBD status is unknown. The study is listed as a single-group model, with WCE compared with MRE findings in the same patients.
The record lists an enrollment of 45 and names capsule endoscopy as the intervention. Allocation is recorded as NA, and masking is recorded as none. The design is therefore not a randomized, masked comparison of separate groups. The registry summary identifies the within-patient relationship between the imaging findings, but does not report the order in which tests were performed, the interval between tests, or any procedures used to standardize interpretation.
The study start is recorded as 2012-08, the primary completion date as 2018-12-30, and the status as completed. The primary outcome timeframe is 1.5 years. The registry record does not report a sample-size justification, a protocol-level statistical plan, or details of how the enrolled participants were selected. It also does not report an analysis population or outcome denominators. Enrollment should not be treated as the number analyzed for a particular endpoint.
Eight outcome measures are listed, including diagnostic yield and sensitivity, specificity, and accuracy measures for MRE and WCE. The record lists no analyses. Thus, the design description establishes the intended diagnostic comparison, but it does not supply the numerical findings needed to assess either test's performance or their relative performance.
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 | Overall Study |
|---|---|
| STARTED | 45 |
| COMPLETED | 27 |
| NOT COMPLETED | 18 |
Reasons for not completing this period:
| Reason | Overall Study |
|---|---|
| Withdrawal by Subject | 7 |
| Lost to Follow-up | 3 |
| Failed screening activities | 8 |
Analysis population for the primary outcome, as defined in the registry: The Diagnostic yield of of MRE were calculated based on how many positive MRE test( with score \>3) divided by total number of MRE studies analyzed.
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 | Overall Study |
|---|---|---|
| Participants analysed | 27 | |
| Age, Continuous | years | 13.46 (SD 2.40) |
| Sex: Female, Male: Female | Participants | 7 |
| Sex: Female, Male: Male | Participants | 20 |
| Race/Ethnicity, Customized: Race Unrecorded | Participants | 27 |
| Region of Enrollment: United States | Participants | 27 |
| Body Mass Index BMI percentile of each IBD patients | Percentile | 57 (SD 32.9) |
| Pediatric Crohns Disease Activity Index PCDAI | units on a scale | 10.2 (SD 12.5) |
| Duration of disease year | years | 1.7 (SD 2.32) |
| Percentage of patients with biologics use with or without immune modulators | Percent of patients | 44.4 |
| Percentage of patients with inflammatory phenotype of IBD | Percent of patients | 93 |
| Percentage of patients with stricturing phenotype of IBD | Percent of patients | 7 |
6. Primary Endpoint
The registry lists the primary outcome as Diagnostic Yield of Magnetic Resonance Enterography (MRE), measured over 1.5 years.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | % Percentage of Diagnostic yeild |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the diagnostic yield of MRE, described as the percentage of positive MRE studies among the MRE studies analyzed. A study is considered positive under the stated criterion when its radiological findings score is >3. The listed findings include small-bowel wall thickness and enhancement, mucosal and serosal enhancement suggestive of mesenteric fatty infiltration, strictures, comb sign, reactive mesenteric lymphadenopathy, fistula, abscess, and the number of small-bowel segments involved.
Diagnostic yield describes how often a test produces a positive result in the studies included in its denominator. It is useful for describing the frequency of positive findings under a specified threshold. It does not, by itself, establish whether those positive findings correctly identify disease exacerbation. That question requires comparison with an appropriate disease-status reference or other specified criteria, which are not reported in the registry record.
The endpoint is distinct from sensitivity, specificity, and accuracy, which are also listed as secondary outcomes. Those measures address agreement with a defined disease-status classification in different ways. The record does not report a numerical MRE yield, its denominator, or an uncertainty interval, so the size and precision of the primary endpoint cannot be assessed from the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record sets out a diagnostic study question but does not report numerical results for the primary endpoint or the listed secondary outcomes. In particular, it gives no observed MRE diagnostic yield, no WCE diagnostic yield, and no sensitivity, specificity, or accuracy estimates. The record also lists no analyses. Consequently, there is no reported estimate from which to judge the magnitude or precision of the imaging findings, and no reported inferential comparison between WCE and MRE.
The primary endpoint is a proportion of positive MRE studies defined by a radiological score threshold. Without the number of positive studies and the number analyzed, that proportion cannot be interpreted. Even a reported proportion would describe the frequency of positive findings under the stated rule; it would not alone establish whether the findings correspond to disease exacerbation. Assessment of that correspondence depends on how disease status was established, and the registry record does not report a reference standard or adjudication procedure.
The study describes both imaging approaches in the same group of patients. In general, within-patient comparisons can account for the fact that each test is evaluated in the context of the same participant, but the interpretation depends on paired results and the analysis used. The record does not give the paired test outcomes, the number of discordant findings, or a statistical comparison. It is therefore not possible to infer whether the tests agreed, whether one identified findings missed by the other, or whether either had greater diagnostic performance.
The registry summary says the study was intended to help assess whether capsule endoscopy is superior or complementary to MRE. That stated aim is not itself evidence of superiority or complementarity. The primary outcome measures MRE diagnostic yield; the listed secondary outcomes include diagnostic performance measures for both modalities, but their results are not reported. No conclusion about comparative performance can be drawn from the outcome titles alone.
Precision is also not assessable. A confidence interval would show the range of values compatible with the data under the chosen statistical method; none is reported for the diagnostic outcomes. A p-value or other inferential comparison is likewise not reported. The enrollment figure is not a substitute for endpoint-specific denominators, because the number of participants contributing usable data to each analysis is not stated.
The appropriate reading is therefore limited to the registered question and design: a completed prospective study planned to examine MRE and WCE in children with known IBD, with both tests compared in the same group. The registry record does not provide the diagnostic estimates needed to answer that question quantitatively.
9. Statistical Methods Explained
The registry identifies the primary outcome as a percentage of positive MRE studies, with positivity defined using a radiological score threshold. The record does not describe the statistical procedures used to analyze the outcome. The concepts below are general statistical context, not a claim about methods used in this study.
What does diagnostic yield describe?
Diagnostic yield is the proportion of evaluated studies that meet a prespecified positive-test rule. Its denominator is the set of studies included in the analysis, and its numerator is the subset classified as positive. The threshold matters: changing the rule for a positive result can change the proportion classified as positive. Here, the registry description uses a score greater than the stated threshold and lists several radiological findings that contribute to the assessment. The registry record does not report the observed numerator or denominator, so the yield cannot be reconstructed.
A yield is a descriptive measure of positive findings. It is not interchangeable with sensitivity, specificity, or accuracy. Sensitivity describes the fraction of participants with the target condition who test positive. Specificity describes the fraction without the target condition who test negative. Accuracy describes the fraction classified correctly under a defined disease-status standard. These measures require a way to classify participants as having or not having the target condition. The registry record lists sensitivity, specificity, and accuracy outcomes but does not report the reference standard or their estimates.
Why does the same-group comparison matter?
The record states that WCE findings are compared with MRE findings in the same group of patients. In general, measurements from the same person are related rather than independent. A paired analysis accounts for that relationship; a method designed for separate independent groups may not. For diagnostic tests, the pattern of agreement and disagreement between the paired results can be especially informative. The registry record does not report paired outcome data or identify the statistical test used, so it is not possible to determine how the comparison was analyzed.
Similar test results do not necessarily establish diagnostic correctness. Two imaging tests could agree while both differ from the underlying disease status, or they could disagree without the record clarifying which result better reflects that status. A comparison of diagnostic performance therefore depends on the target condition, its definition, the reference standard, and the prespecified analysis. Those details are not reported in the registry record.
How should uncertainty be understood?
A confidence interval expresses statistical uncertainty around an estimate under a specified model and analysis. For a diagnostic yield, it would help show how precisely the observed proportion is estimated. For paired diagnostic measures, an interval around a difference or another comparison could convey uncertainty in the relative performance. The registry record does not report confidence intervals or any other uncertainty estimates for the outcomes.
A p-value, when used appropriately, addresses how compatible observed data are with a specified null hypothesis under the analysis assumptions. It is not a measure of the size or clinical importance of an effect, and it does not replace an estimate with an uncertainty interval. No p-values or inferential analyses are listed in the registry record. The absence of a reported test means the record cannot establish a statistically supported difference between the imaging modalities.
What can the enrollment figure tell readers?
The registry lists enrollment of 45. That is a study-level enrollment figure, not necessarily the denominator for every outcome. Participants may have different availability of test results or endpoint information; whether that occurred in this study is not reported. The number included in each analysis, reasons for missing data, and methods for handling missing observations are also not reported. Without those details, readers cannot assess the effective information available for a particular diagnostic estimate.
Any sample-size illustrations based on an observed effect should be interpreted as planning scenarios, not as observed power or as the study's original design justification. The registry record does not report a sample-size justification or the trial's own statistical planning rationale. It also does not report an interim-analysis plan or a prespecified multiplicity procedure.
Because several diagnostic outcomes are listed, multiplicity is a relevant general consideration: making many statistical comparisons can increase the chance of at least one apparently notable result if no adjustment or interpretive strategy is specified. The record lists eight outcome measures, but it does not report the analysis hierarchy, adjustment method, or results. These gaps prevent assessment of how outcome selection and multiple testing were handled.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists eight outcome measures: the primary MRE diagnostic-yield measure and secondary measures of sensitivity, specificity, and accuracy for MRE and WCE. It lists no analyses. No analysis hierarchy, multiplicity adjustment, or strategy for interpreting multiple outcomes is reported in the registry record. This matters because, in general, considering several outcomes can create multiple opportunities for apparently noteworthy findings. Without a reported plan and results, readers cannot assess whether or how that issue was addressed.
Missing-data handling is not reported. The record does not state how many participants had usable results for each endpoint, whether any test results were unavailable, why data might have been missing, or how missing observations were handled. Enrollment of 45 is not an endpoint-specific denominator and should not be taken as proof that every enrolled participant contributed to every analysis.
The analysis population is also not reported. The record does not specify whether outcome calculations used all enrolled participants, only participants who completed both imaging procedures, or another defined group. It does not describe exclusions from analysis or how incomplete paired results would be treated. These are important details for interpreting diagnostic estimates, especially when the comparison is within the same patients.
The registry record does not report a statistical analysis plan, an interim-analysis plan, or a sample-size justification. Their absence from the record should not be filled in by assumption. As a result, the planned handling of multiplicity, missing outcomes, and analysis populations remains unclear.
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 |
|---|---|---|---|
| Overall Study | 0 | 45 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Overall Study | 0 of 45 |
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 |
|---|---|
| Overall Study | 0 of 45 |
The registry adverse-event figures list 45 participants at risk for serious adverse events and 0 affected. For other adverse events, the figures also list 45 at risk and 0 affected. Deaths are recorded as 0, and no top serious-event terms are listed.
These are the adverse-event counts reported in the registry record. They describe what was recorded for this study; they do not demonstrate that the procedures carry no risk or rule out events that were not captured or reported. The record does not provide further details about adverse-event definitions, collection procedures, observation time for safety reporting, or event severity apart from the serious-event categorization. The figures should therefore be read as reported counts, not as a comprehensive estimate of risk in other settings or populations.
12. What the Result Does, and Does Not, Mean
The record establishes that the study was designed to examine WCE and MRE in children with known IBD, with the imaging findings compared in the same group. It identifies MRE diagnostic yield as the primary outcome and describes the radiological threshold used to classify an MRE study as positive. Those details clarify the intended question and the meaning of a positive MRE result under the study criteria.
The registry record does not report the numerical outcome results. It therefore does not establish how often MRE was positive, how often WCE was positive, or how either modality performed against a reference standard. It also does not report a comparative estimate, confidence interval, or inferential analysis. No conclusion that one test is superior, equivalent, or complementary to the other follows from the design description alone.
The record's enrollment figure does not indicate how many patients contributed to each outcome, and no endpoint-specific denominators are reported. The absence of analysis details also limits assessment of missing data, the paired comparison, and the statistical handling of the listed outcomes. These omissions constrain what readers can conclude from the registry record, even though the study status is completed.
The distinction between a positive-test frequency and diagnostic accuracy is important. A positive MRE yield describes how often the specified positivity rule was met. To assess whether positive and negative findings correctly characterize disease status, a defined reference classification and the corresponding diagnostic results are needed. Those results and the reference procedure are not reported in the registry record.
In short, the record supports a description of the study's aims, design, endpoint definition, and reported adverse-event counts. It does not support a quantitative conclusion about diagnostic performance or comparative benefit. The intended clinical question remains unanswered by the outcome information reported in the registry record.
13. Why This Trial Matters Statistically
This study is statistically notable for its within-patient diagnostic comparison. Evaluating WCE and MRE in the same group can make paired evidence relevant: the relationship between each patient's test findings may matter as much as the overall positive-test frequency. In general, paired data require analyses that respect this dependence. The registry record describes the same-group comparison but does not report the paired results or analysis method.
The primary outcome also illustrates why endpoint definitions matter. MRE diagnostic yield is defined through a score-based positive-test rule. A clear rule makes the intended classification interpretable, but yield answers a different question from whether the test correctly identifies disease status. The listed secondary outcomes of sensitivity, specificity, and accuracy address different aspects of diagnostic performance, yet their estimates are not reported.
The record also shows the distinction between a completed study and a complete registry account of its findings. Completion status and enrollment describe study administration, while outcome estimates, denominators, uncertainty intervals, and analysis methods are needed for statistical interpretation. Those diagnostic results are not reported in the registry record.
Finally, the study's stated aim raises a comparison between superiority and complementarity. These are not interchangeable claims: superiority requires an appropriate comparative estimate, while complementarity concerns whether tests contribute useful information in relation to one another. The record's stated aim and within-group design make those questions relevant, but without reported paired results and analysis, neither can be answered quantitatively from the registry record.
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 interpretation is that the registry record does not report numerical results for the primary or secondary diagnostic outcomes. There are no reported endpoint denominators, estimates, confidence intervals, or inferential analyses. A completed status does not resolve this lack of outcome information.
The primary endpoint is MRE diagnostic yield, but the record does not report the observed yield or the number of MRE studies analyzed. The result's precision is therefore unknown. Although sensitivity, specificity, and accuracy are listed for the imaging tests, their values are not reported. The registry record also does not describe the reference standard or the procedure used to determine disease status for those measures.
The design description says the tests were compared in the same group, but the record does not report paired results, test timing, interpretation procedures, or how disagreements were assessed. It does not report the analysis population, missing-data handling, or reasons for any unavailable outcomes. The enrolled population may not be identical to the set contributing data to each endpoint; the record does not specify those denominators.
Allocation is recorded as NA, masking as none, and the model as single group. The registry record does not describe steps used to reduce the potential influence of unmasked interpretation or other measurement procedures. It also does not report a sample-size justification, statistical plan, interim-analysis plan, or multiplicity procedure. These details cannot be inferred from the completed status or the listed outcomes.
These limitations are specific to what the registry record reports. They prevent a quantitative judgment about MRE or WCE diagnostic performance, but they do not establish that the study procedures themselves were inadequate.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Capsule Endoscopy in Inflammatory Bowel Disease (IBD) in Children — NCT02182947.
- Registry record last updated 2021-03-11; status last verified 2021-02.
- Results first posted 2021-03-11.
- 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
NCT02182947 is a completed prospective study titled Capsule Endoscopy in Inflammatory Bowel Disease (IBD) in Children. The official title describes a comparison of wireless capsule endoscopy with magnetic resonance enterography in children with IBD. The registry lists an enrollment of 45, a single-group model, allocation as NA, and no masking. WCE and MRE findings were to be compared in the same group.
The primary outcome is MRE diagnostic yield, defined as the percentage of positive studies under a radiological score criterion of >3. Listed secondary outcomes include sensitivity, specificity, and accuracy for MRE and WCE. The registry record lists no analyses and does not report numerical diagnostic results, endpoint denominators, uncertainty estimates, or the reference standard used for diagnostic-performance measures.
The study status is completed. Serious adverse events, other adverse events, and deaths are recorded as 0 in the reported figures. The record supports a description of the study's question and design, but not a quantitative conclusion about the comparative diagnostic performance of the two imaging approaches.