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 Core Biopsy Endo Sonography Study Evaluation of the Significance of the Pro-core® Needle (NCT02181140), a na na study. The primary outcome is Diagnostic Accuracy.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02181140 |
| Phase | NA |
| Condition | Pancreatic Neoplasm |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 56 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Universitätsklinikum Hamburg-Eppendorf |
| Results posted | Yes |
2. Clinical Question
Population
The registry record concerns people with a pancreatic neoplasm and a space-occupying process identified by endosonography. The planned assessment was diagnostic, and the record lists enrollment of 56. Further eligibility criteria and participant characteristics are not reported in the registry record.
Intervention
The procedure description specifies EUS-guided fine needle aspiration using a Pro-core needle, with histological and cytological assessment and a quality assessment by pathologists. The needles are described as 22 G.
Comparator
The comparator is conventional fine needle aspiration using an Echotip aspiration needle, also described as 22 G. The record says both needles were used in a randomized order in each lesion; allocation is listed as NA, so this is not a conventional randomized parallel-group comparison.
Primary question
The primary question is whether diagnostic accuracy differs between the Pro-core needle and conventional fine needle aspiration, using the histopathological diagnosis after surgery or clinical follow-up of at least one year after EUS FNA as the stated standard. The actual diagnostic-accuracy results are not reported in the registry record.
3. Trial Design
This is a completed, single-group study record with enrollment listed as 56. Its title and primary-outcome description concern a comparison of Pro-core needle sampling with conventional fine needle aspiration for differential diagnosis of tumorous and inflammatory processes. The intervention is described as EUS-guided FNA and fine needle puncture. In each lesion, both needles were used in a randomized order. Thus, the comparison is within lesion rather than a comparison of separately allocated treatment arms. Allocation is listed as NA, and masking is listed as none.
The distinction between randomized order and randomized allocation matters. Randomizing which needle is used first may help prevent systematic order effects from always favoring the same needle. It does not make this a parallel-arm randomized trial: the record does not describe separate groups assigned to receive only one needle. The registry also flags that this is not a randomized comparison and that arms are not a like-for-like control comparison. The paired-by-lesion procedure is part of the study description, but the record does not report how paired observations were analyzed.
The listed condition is pancreatic neoplasm. The primary endpoint has a timeframe of up to 1 year. For its reference diagnosis, the description names histopathological diagnosis after surgery or clinical follow-up of at least one year after EUS FNA. The study status is completed. The recorded start is 2011-08 and primary completion is 2014-10. Phase is listed as NA. The sponsor is Universitätsklinikum Hamburg-Eppendorf.
The record lists two secondary outcomes: histology samples for EUS Pro Core FNA and complication rates. It lists three outcome measures overall, but further outcome detail and analysis entries are not reported in the registry record. The completed status indicates that the study is recorded as completed; it does not establish that the outcome results were entered into the registry.
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 | EUS Guided FNA and Fine Needle Punction |
|---|---|
| STARTED | 56 |
| COMPLETED | 56 |
| NOT COMPLETED | 0 |
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | EUS Guided FNA and Fine Needle Punction |
|---|---|---|
| Participants analysed | 56 | |
| Age, Continuous | years | 67.5 (34 to 87) |
| Sex: Female, Male: Female | Participants | 27 |
| Sex: Female, Male: Male | Participants | 29 |
| Region of Enrollment: Germany | participants | 56 |
6. Primary Endpoint
The registry lists the primary outcome as Diagnostic Accuracy, measured over up to 1 year.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | Diagnostic accuracy (%) |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is diagnostic accuracy, expressed as a percentage, for the Pro-core needle compared with conventional fine needle aspiration. The endpoint addresses how well sampling results correspond to the stated reference diagnosis. The record describes histological and cytological diagnosis and quality assessment for Pro-core samples by pathologists, and reference cytology evaluation for the Echotip aspiration needle by cytology experts. The standard for judging the diagnosis is described as histopathological diagnosis after surgery or clinical follow-up of at least one year after EUS FNA.
Diagnostic accuracy is used to summarize agreement between a test result and a reference classification. As a general statistical point, that summary can be informative about overall classification, but it does not by itself show how performance varies across particular diagnostic categories. Measures such as sensitivity and specificity answer different questions and are not separately reported as primary outcomes in this record.
The endpoint description gives a timeframe of up to 1 year, but the registry does not report the observed accuracy for either needle, the number of evaluable lesions, or the method used to form the percentage. It also does not report uncertainty around the accuracy estimates. Consequently, the endpoint’s intended comparison can be described, but its result and precision cannot be assessed from the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The central limitation for interpreting this study is that its primary result is not reported in the registry record. The primary endpoint is diagnostic accuracy for Pro-core compared with conventional fine needle aspiration, but no accuracy estimates, comparison estimate, confidence interval, or test result is included. Therefore the record does not establish which needle had higher reported accuracy or how precise any difference may have been. No conclusion about diagnostic performance can be drawn from the endpoint description alone.
The design has a within-lesion feature: both needles were used in each lesion, in randomized order. This differs from a parallel-group design in which distinct groups receive different procedures. A within-lesion comparison can account for characteristics shared by samples taken from the same lesion, but it also requires an analysis that respects the paired observations. The registry record does not describe that analysis. The fact that order was randomized does not supply a statistical result and does not resolve the absence of reported outcome data.
The record lists enrollment of 56 and describes the trial as completed. Enrollment is not the same as the number contributing to the primary endpoint. The number of participants, lesions, or samples included in the diagnostic-accuracy analysis, and any exclusions or missing results, are not reported in the registry record. Without those details, it is not possible to determine the analysis population or assess whether the available observations represent all enrolled participants.
The endpoint uses a reference diagnosis based on histopathology after surgery or clinical follow-up of at least one year after EUS FNA. This provides the stated basis for judging diagnostic accuracy, but the registry does not report how many cases received each type of reference assessment, whether reference assessment was complete, or whether adjudication procedures were used. These details could affect how accuracy is estimated, but they cannot be assumed.
For planning, an accompanying illustration is described as using the observed effect, a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation. Such planning calculations are not evidence of the study’s observed performance and are not observed power. The registry record does not report the trial’s own design justification or analysis plan. Since the outcome estimates are absent, the planning assumptions should not be treated as a substitute for the missing results.
The safety record lists 56 at risk and 0 affected in both the serious-adverse-event and other-adverse-event categories for the EUS Guided FNA group. This is a report of recorded counts, not proof that no adverse events occurred outside the registry’s reporting or ascertainment. Deaths are not reported in the registry record. Taken together, the available information describes study design and recorded safety counts, but it is insufficient to quantify diagnostic accuracy or compare the needles’ results.
9. Statistical Methods Explained
The registry describes a diagnostic comparison, not a conventional treatment-effect trial. Its primary endpoint is diagnostic accuracy (%) for two sampling needles, and the procedure description says both needles were used in randomized order in each lesion. Understanding that structure is important because the observations from the two needles within a lesion are related. A statistical analysis should reflect that relationship rather than treat each needle’s observations as if they came from unrelated groups. The method actually used is not reported in the registry record.
What does diagnostic accuracy represent?
As a general statistical explanation, diagnostic accuracy summarizes the proportion of classifications that agree with a chosen reference diagnosis. The reference matters: a test result can only be judged against the classification treated as the standard. In this record, the described standard is histopathological diagnosis after surgery or clinical follow-up of at least one year after EUS FNA. The registry does not report the observed accuracy percentages, the underlying counts, or the precise calculation rules. It therefore does not permit verification of how the endpoint was calculated.
Accuracy is an overall summary and does not describe all aspects of a diagnostic test. In general, sensitivity concerns identifying cases with a specified condition, while specificity concerns correctly classifying cases without it. These measures answer distinct questions. They are not separately reported as primary outcomes in the registry record, and no values for them should be inferred from the accuracy endpoint. Nor does the endpoint description state how indeterminate or inadequate samples were handled.
Why does the within-lesion design matter?
In a paired design, measurements from the same unit are linked. Here, the record says both needles were used in each lesion, with the order randomized. General statistical reasoning says that a paired comparison should focus on how the two methods differ within the same lesion, while accounting for the correlation between their results. An analysis that ignores pairing may misstate uncertainty because it treats linked observations as independent. The registry record does not identify whether a paired method was used, how lesions were matched to results, or how any repeated or incomplete samples were handled.
Randomized order is relevant to procedure sequence. If the first or later sampling attempt can influence sample quality, assigning order at random can reduce systematic ordering bias. It does not mean that participants or lesions were randomly allocated to separate study arms. Allocation is listed as NA, masking as none, and the registry flags that this is not a randomized comparison with like-for-like control arms. These design labels should be read alongside the specific description of randomized needle order, rather than conflated with random assignment to treatment groups.
How should uncertainty be assessed?
As a general explanation, an estimate describes the observed result, while a confidence interval describes the range of values reasonably compatible with the data under the statistical model. A narrow interval indicates greater precision than a wide interval, but precision does not by itself establish that a method is clinically preferable. For this study, neither accuracy estimates nor confidence intervals are reported in the registry record. The precision of the primary comparison therefore cannot be evaluated.
When observations are paired, uncertainty in the comparison depends on the pattern of agreement and disagreement within lesions, not merely on separate totals for each needle. Overall counts for each method, without the pairing information, may not be sufficient to reconstruct a paired comparison. The registry does not provide the cross-classification of results or the number of evaluable paired observations. No recalculated comparison can be made from the posted record.
What do the planning assumptions mean?
The sample-size illustration is described as a planning calculation based on the observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It considers the effect to detect as a stated fraction of the observed effect. These are assumptions for an illustration, not evidence that the trial was designed using those assumptions. The actual sample-size justification and protocol plan are not reported in the registry record.
As a general concept, a planning calculation estimates how much information a future study might need to detect a specified effect under stated assumptions. It does not report the probability that the completed study’s result is correct, and it is not observed power. Here, the described illustration uses an observed effect, but the registry record does not report the primary result from which that effect could be inspected. The calculated planning scenarios therefore cannot replace the absent trial outcome or show whether the study met a prespecified target.
The illustration’s assumption of equal allocation between two arms also differs from the described study structure, where both needles were used in each lesion. The design description does not establish that the planning model matches the paired sampling approach. The model assumptions should consequently be treated as planning conventions rather than as a description of the actual analysis.
Why can over-dispersion matter?
As a general statistical point, over-dispersion occurs when observed variability is greater than a model assumes. If a count model assumes less variability than the data contain, it can make uncertainty appear too small. Such concerns are relevant in some analyses of counts or clustered observations, but the registry record does not report a count model, dispersion estimate, or analysis of this kind. No conclusion about over-dispersion in this study is available.
The registry lists no analysis entries. The analysis method, statistical software, handling of multiple outcomes, missing-data approach, and analysis population are not reported in the registry record. Statistical interpretation is therefore limited to the design and endpoint descriptions; the data needed to assess the actual analysis and its uncertainty are absent.
10. Multiplicity, Missing Data and Analysis Populations
The record lists a primary endpoint of diagnostic accuracy and two named secondary outcomes: histology samples for EUS Pro Core FNA and complication rates. It also lists three outcome measures overall. The registry does not provide further detail for all outcome measures or explain whether any additional analyses were planned. No multiplicity adjustment or hierarchy for testing outcomes is reported in the registry record.
Multiplicity refers, in general, to the added chance of obtaining apparently notable findings when many outcomes or comparisons are examined. Whether and how to address it depends on the prespecified questions and analysis plan. That plan is not reported, so it is not possible to determine whether an adjustment was intended or appropriate. The number of analysis entries is listed as 0, and no inferential results are reported.
The registry lists enrollment of 56, but the number included in each outcome analysis is not reported. Missing primary results, unavailable samples, indeterminate findings, withdrawals, and exclusions are not described. The record also does not say whether the analysis included all enrolled participants, all lesions, or only lesions with complete paired sampling and a reference diagnosis. These omissions prevent assessment of missingness and of whether the analyzed observations could differ systematically from those not analyzed.
As a general principle, complete-case analysis can be biased when the likelihood of having an observed result is related to the result or to participant characteristics. Other approaches require assumptions about the missing data and an analysis plan. No missing-data method is reported in the registry record, so none can be attributed to this study. The trial’s analysis populations and handling of incomplete data remain unknown.
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 |
|---|---|---|---|
| EUS Guided FNA | 0 | 56 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| EUS Guided FNA | 0 of 56 |
The registry’s safety entry is for the EUS Guided FNA group. It records 56 at risk and 0 affected for serious adverse events, and 56 at risk and 0 affected for other adverse events. These are the posted counts. They do not establish that risk was absent or that all events were captured and reported. No serious adverse-event terms are listed, and deaths are not reported in the registry record.
As a general statistical point, a count of zero observed events is not evidence that the underlying event risk is exactly zero. The interpretation depends on the completeness of follow-up, event definitions, reporting procedures, and the population included in safety monitoring. Those details are not reported in the registry record. The record also does not describe event severity beyond the serious-versus-other categories, timing, attribution, or how safety data were collected.
The safety counts do not provide a comparative estimate between needles. The registry describes both needles being used in each lesion, but it gives one EUS Guided FNA safety group rather than needle-specific event counts. It is therefore not possible to attribute the recorded counts to one needle or compare safety between the procedures from this entry. Zero recorded affected participants should be read as a registry count, not as proof of no harm.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a completed study was designed to compare diagnostic accuracy for Pro-core and conventional fine needle aspiration. It describes both needles being used in randomized order in each lesion, specifies the reference diagnosis, and lists enrollment of 56. It also records zero affected participants in the serious and other adverse-event categories for the EUS Guided FNA group. These registry entries describe the study’s design and the safety counts entered in the record.
The record does not report the primary diagnostic-accuracy values, a comparison between needles, confidence intervals, or statistical test results. It therefore cannot establish whether the accuracy estimates differed, how large any difference was, or how precisely an estimate was measured. It also does not permit independent calculation of the primary result because the underlying sample and reference-diagnosis counts are absent.
The within-lesion procedure description is not equivalent to a randomized parallel-group trial. Randomizing the order of the two needles is distinct from randomly allocating participants to one needle or the other. The record states that order was randomized, but does not report the statistical method used to account for paired observations. This limits assessment of the analysis even apart from the missing outcomes.
Likewise, the safety counts do not show that risk was absent. They are counts recorded for the listed group, without needle-specific event attribution or reported details about follow-up and ascertainment. Deaths are not reported in the registry record. The counts should not be used to claim that one procedure is safer than the other.
The planning illustration is not a trial result. Its stated assumptions—two-sided significance level 0.05, equal allocation, and normal approximation—describe a planning approach, not the study’s observed analysis or power. The registry does not report its own sample-size justification or statistical plan. Overall, the available record supports a description of the intended diagnostic question and study structure, but not a conclusion about relative diagnostic performance or comparative safety.
13. Why This Trial Matters Statistically
This study raises a useful statistical distinction between randomizing procedure order and randomizing participants to different groups. The record says both needles were used in each lesion in randomized order, yet allocation is listed as NA and the registry flags that the study is not a randomized comparison. Describing those features accurately prevents the design from being mistaken for a parallel-group trial.
The study also illustrates why the unit of analysis matters. When two diagnostic methods are applied to the same lesion, their results are linked. A valid comparison should reflect that pairing. The registry’s description makes the paired structure visible, but does not report the analysis method or the paired result. This gap is important because a design description alone cannot establish that the statistical analysis matched the data structure.
Reference standards are another central issue in diagnostic research. The record identifies surgery-based histopathology or clinical follow-up of at least one year as the basis for judging the needle results. How that reference was applied, and whether it was available for every lesion, can affect the interpretation of diagnostic accuracy. Those details are not reported in the registry record.
Finally, this record shows why completion status should not be confused with availability of results. Although the study is completed and enrollment is recorded, the primary endpoint values and analysis are absent. A clearly defined question and endpoint are not substitutes for estimates and uncertainty. Without those results, readers can assess the stated design but cannot judge diagnostic performance or compare the methods statistically.
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 trial-specific limitation is the absence of reported primary outcome results. Diagnostic accuracy is named as the primary endpoint, but the registry record gives no estimate for either needle, no comparison, and no uncertainty measure. The listed enrollment does not establish how many lesions or samples contributed to the endpoint, so the evaluable analysis size is unknown.
The procedure description implies paired observations because both needles were used in each lesion. However, the record does not report the statistical method used to account for that pairing, whether all paired results were complete, or how multiple samples from a lesion were handled. Randomized order is reported, but allocation to separate arms is NA and masking is listed as none. These features limit the design’s interpretation and the ability to assess bias.
The reference diagnosis is described as surgery-based histopathology or clinical follow-up of at least one year after EUS FNA. The registry does not report how often each reference pathway was used, whether reference information was available for every lesion, or how cases without a definitive reference diagnosis were treated. It also does not describe how indeterminate or inadequate needle samples were classified.
Participant characteristics, detailed eligibility criteria, withdrawals, exclusions, and analysis populations are not reported in the registry record. The actual statistical analysis plan, missing-data procedures, and multiplicity approach are also not reported. The safety entry provides counts for one group but no needle-specific attribution, event timing, or detailed ascertainment information; deaths are not reported. These limitations mean that neither diagnostic performance nor comparative safety can be fully evaluated from the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Core Biopsy Endo Sonography Study Evaluation of the Significance of the Pro-core® Needle — NCT02181140.
- Registry record last updated 2019-06-18; status last verified 2019-04.
- Results first posted 2015-09-16.
- 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
This completed study record concerns evaluation of the Pro-core needle for diagnostic accuracy compared with conventional fine needle aspiration. It lists pancreatic neoplasm as the condition and enrollment of 56. Both 22 G needles were described as being used in randomized order in each lesion. Allocation is NA, masking is none, and the design is listed as single group. The recorded start is 2011-08 and primary completion is 2014-10.
The primary endpoint is diagnostic accuracy (%) with a timeframe of up to 1 year. The stated reference is histopathological diagnosis after surgery or clinical follow-up of at least one year after EUS FNA. Named secondary outcomes are histology samples for EUS Pro Core FNA and complication rates. The primary result and analysis method are not reported in the registry record.
The safety entry records 0 affected in the serious and other adverse-event categories, with 56 at risk in each category. Deaths are not reported in the registry record. The record supports interpretation of the intended question and design, but not a conclusion about the comparative diagnostic results.