Comparison of a Novel 22-gauge Core Biopsy Needle: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Comparison of a Novel 22-gauge Core Biopsy Needle (NCT01598194), a na na study. The primary outcome is Comparison of Diagnostic Adequacy Scores With SST vs. CST for Cytologic Diagnosis Using a 22G Core Needle..

2. Clinical Question

The central statistical question is about diagnostic adequacy: whether material collected during the procedure is sufficient for interpretation. The registry defines adequacy in terms of obtaining cytological aspirates or histological core tissue samples that are sufficient for diagnostic interpretation. This is a measure of specimen acquisition, not a report of a final diagnosis or of patient outcomes.

The described procedure includes four study passes for each participant: two with a standard 25-gauge needle using SST, plus two with the 22-gauge core needle using either SST or CST. For the 22-gauge needle, the description assigns one pass for cytologic analysis and one for histologic analysis. The registry's account therefore includes both a comparison of suction techniques and a comparison with standard FNA sampling.

The registry does not report the diagnostic adequacy counts or the results of either comparison. Consequently, the page can explain the question and its design, but cannot state which approach produced more adequate specimens or how precisely any difference was estimated.

3. Trial Design

This is a prospective study of a novel 22-gauge core biopsy needle with reverse-bevel design compared with standard endoscopic ultrasound-guided FNA needles for solid pancreatic lesions. The registry lists an enrollment of 60 participants and marks the study as completed. It records a start date of 2012-01-30 and a primary completion date of 2017-07-06. The sponsor is M.D. Anderson Cancer Center.

The stated procedure gives each participant four study passes. Two passes use a standard 25-gauge needle with standard suction technique (SST). The other two use the 22-gauge core needle: one for cytologic analysis and one for histologic analysis. The description says participants were assigned to one of two groups for these core-needle passes, with group 1 using SST and group 2 using capillary suction technique (CST). The primary outcome description focuses on diagnostic adequacy with the core needle under SST versus CST. A secondary outcome concerns cytologic adequacy for a single pass with the core needle and the standard 25-gauge needle.

There is an important design-description tension in the registry. It labels the model as single group and allocation as NA, and the record flags that this is not a randomized comparison with like-for-like control arms. At the same time, the procedure description says participants were randomly assigned to one of two groups for the core-needle passes. The record does not explain how these descriptions relate, so the design should not be summarized as a conventional randomized controlled trial.

Masking is listed as none, and the phase is listed as NA. The registry does not report a detailed allocation procedure, eligibility criteria, a protocol-based sample-size justification, interim analyses, or a statistical analysis plan. The stated procedure time is about 1 hour for each EGD EUS-FNA endoscopy procedure, with each needle pass taking about 1-2 minutes.

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

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.

6. Primary Endpoint

The registry lists the primary outcome as Comparison of Diagnostic Adequacy Scores With SST vs. CST for Cytologic Diagnosis Using a 22G Core Needle., measured over Each EGD EUS-FNA endoscopy procedure takes about 1 hour. Each needle pass takes about 1-2 minutes..

The primary endpoint concerns diagnostic adequacy scores for the 22-gauge core biopsy needle using SST compared with CST for cytologic diagnosis. The record describes adequacy as obtaining cytological aspirates or histological core tissue samples that are sufficient for diagnostic interpretation. This makes the endpoint a measure of whether the collected material can support interpretation, rather than a measure of whether a participant has a particular disease or experiences a later clinical outcome.

The endpoint is useful for evaluating the specimen-collection process. Needle design and suction technique are relevant to how material is obtained, while adequacy captures whether the resulting sample meets the stated interpretive threshold. The registry also describes comparing the 22-gauge needle with a standard 25-gauge needle for cytologic diagnosis, and a secondary outcome specifically names the comparison of diagnostic adequacy from a single pass.

The primary measure is listed in participants, with a count-of-participants parameter. However, the record does not report the adequacy counts, the denominator used for each reported comparison, or a numerical score definition beyond the stated sufficiency criterion. It therefore does not permit readers to assess the observed adequacy in either suction-technique group, the size or direction of any contrast, or the precision of an estimate.

Interpretation also depends on keeping the specimen types and comparisons distinct. Cytologic aspirates and histologic core tissue are both included in the general adequacy definition, while the primary title specifies cytologic diagnosis. The procedure description assigns separate core-needle passes for cytologic and histologic analysis. The registry does not provide enough results detail to determine how adequacy was summarized across those specimen types.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes a binary-type endpoint recorded as counts of participants, but does not provide the actual endpoint counts or statistical analyses. The explanations below are general statistical context for understanding this kind of outcome; they are not a claim that the registry used a particular method.

What does diagnostic adequacy represent?

In general, a binary endpoint classifies each observation into one of two categories, such as meeting or not meeting a prespecified adequacy criterion. The registry defines adequate material as a cytological aspirate or histological core tissue sample sufficient for diagnostic interpretation. A count of participants with adequate material can communicate how many met that criterion, but interpretation also requires a clear denominator and a clear rule for classifying participants with more than one pass or specimen.

The record describes multiple passes per participant and distinguishes cytologic from histologic analysis. This means that the statistical unit needs to be understood carefully. If the endpoint is a participant-level count, the analysis needs a stated rule for combining information from multiple passes. If individual passes are analyzed, observations from the same participant may be related rather than independent. The registry does not report how this issue was handled.

How are comparisons of binary outcomes interpreted?

In general, a comparison of two binary outcomes can be expressed using counts, proportions, or a contrast between proportions. The choice of measure affects interpretation: counts show the number of observations in each category, while proportions relate those counts to a denominator. A difference between proportions is an absolute contrast; a ratio compares relative levels. Each measure answers a different question, and none can be reconstructed because the registry does not report the outcome counts or analysis results.

Uncertainty matters alongside the point estimate. A confidence interval conveys how much uncertainty remains under the chosen model and assumptions. Narrower intervals generally indicate greater precision, while wider intervals indicate less precision. An interval that includes values on both sides of a null contrast may be compatible with a range of possible effects; it does not prove that the true contrast is exactly zero. No confidence interval is reported for the adequacy outcomes in this record.

A hypothesis test and its p-value are also not a substitute for the effect estimate. In general, a p-value summarizes how unusual the observed data would be under a specified null hypothesis and analysis assumptions. It does not measure the probability that the null hypothesis is true, nor does it describe the size or practical importance of a difference. Because the record lists no analyses, it does not provide a p-value to interpret.

Why can multiple passes affect the analysis?

General statistical reasoning distinguishes the number of participants from the number of specimens or passes. Repeated observations from the same participant can share characteristics, so treating every pass as if it came from a different person may understate uncertainty. Alternatively, an analysis can define a participant-level outcome, but then it needs an explicit rule for how passes contribute to that outcome. The registry lists four study passes per participant and gives their intended roles, but does not report a statistical approach for repeated measurements or a rule for combining specimens.

The procedure also includes two needle approaches and two suction techniques. Comparisons may be affected by the order of passes, the way assignment was implemented, and whether interpretation was blinded, among other design details. Those details are not reported in the registry record, so their influence cannot be evaluated from this entry.

What does the sample-size section mean?

Any sample-size displays on this page are planning illustrations based on an observed effect, not observed power and not the study's original design justification. The stated illustration assumptions are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is expressed as a stated fraction of the observed effect. Such calculations describe hypothetical planning under those assumptions. They do not show that the study was designed with those assumptions, and they do not establish the probability that the completed study detected an effect.

For a planning calculation, changing the effect one aims to detect changes the required sample size: smaller target effects generally require more information to distinguish from random variation. This is a general relationship, not a result specific to this study. Since the registry does not report a protocol-based sample-size justification or the adequacy results, planning illustrations should not be read as evidence that the study had adequate precision for its endpoints.

What can be concluded from missing analyses?

The registry lists zero analyses and does not report an inferential method, adjusted estimate, confidence interval, or p-value. It is therefore not possible to identify an analysis population, assess model assumptions, or determine whether any adjustment was made. The absence of a reported analysis does not mean that no analysis occurred outside the registry; it means those details and results are not reported in the registry record. Readers should distinguish the procedural description from a complete statistical results report.

10. Multiplicity, Missing Data and Analysis Populations

This record describes several related outcome questions: adequacy with the 22-gauge core needle using SST versus CST, and cytologic adequacy in comparison with a standard needle. It also distinguishes cytologic and histologic specimen assessment and identifies a secondary outcome concerning a single pass. When a study examines several outcomes, comparisons, or specimen types, general statistical practice considers whether and how to account for multiplicity. Testing many questions can increase the chance of apparently notable findings arising by chance. The registry does not report a multiplicity strategy or identify a hierarchy among the comparisons.

The primary outcome description gives an adequacy definition and the procedure description gives the pass allocation, but the record does not provide outcome counts, missingness summaries, or analysis populations. It does not report how inadequate, unclassifiable, or unavailable specimens were handled, whether every participant contributed to each comparison, or how incomplete procedures would be represented. These details matter because a denominator that differs across comparisons can change the interpretation of counts and proportions.

The registry also does not report whether analyses followed an intention-to-treat, per-protocol, or other population definition. Because the record labels the model single group and allocation NA while describing assignment to SST and CST groups, the analysis populations and their relationship to the procedure groups cannot be determined from this entry.

These omissions do not establish that the study failed to address multiplicity or missing data in its conduct. They mean that the relevant methods are not reported in the registry record. Without the outcome-level denominators, missing-data handling, and analysis populations, readers cannot judge the robustness or comparability of the endpoint results.

11. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

The registry lists two groups: Standard Suction Technique (SST) and Capillary Suction Technique (CST). For each group, 30 participants are shown as at risk for serious adverse events and 30 for other adverse events. The posted counts show zero participants affected by serious adverse events, zero affected by other adverse events, and zero deaths in each group.

These are event counts as presented in the registry, not a complete description of safety monitoring. The record does not report the observation period for adverse events, the event-collection procedures, severity grading beyond the serious/other categories, or whether events were assessed for relation to the procedure. It also does not provide narrative descriptions of adverse events; the list of top serious terms is empty.

A zero count in the posted categories means that no affected participants are recorded there. It does not demonstrate that the risk of an event is absent, and it does not establish that the groups have equivalent safety. Rare events, incomplete reporting, and limited observation can all affect what can be inferred from event counts in general. Here, the record gives no additional information with which to assess those possibilities. The figures should therefore be read as the registry's tabulation, not as a broad claim about safety.

12. What the Result Does, and Does Not, Mean

This study record matters because it describes a structured comparison of ways to collect diagnostic material from solid pancreatic lesions. It specifies a reverse-bevel 22-gauge core biopsy needle, the SST and CST approaches, standard FNA needle passes, and an adequacy criterion tied to whether material is sufficient for diagnostic interpretation. These details make the intended specimen-collection question understandable.

What the record does not show is the primary result. There are no adequacy counts, effect estimates, confidence intervals, p-values, or listed analyses. It is therefore not possible to say from this record whether adequacy differed between SST and CST, how the core needle compared with a standard 25-gauge needle, or how precise those comparisons were. The enrollment count cannot fill that gap.

In general, a diagnostic adequacy endpoint concerns the quality or interpretability of the specimen obtained under the study's definition. It does not by itself establish the accuracy of a final diagnosis, effects on subsequent care, or patient outcomes. Those are distinct questions and are not reported. Likewise, the adverse-event counts are limited registry tabulations and do not provide a complete assessment of safety.

The description of group assignment should also be interpreted cautiously. The record identifies the study as single group and lists allocation as NA, while the procedure description refers to random assignment to SST or CST for the core-needle passes. It does not reconcile these statements. This uncertainty limits how confidently readers can characterize the study's comparative design based on the registry entry alone.

In short, the record documents the study's purpose, procedure, and endpoint definition, but it is not a results report adequate to support conclusions about comparative diagnostic performance. Any such conclusion would require outcome data and analysis details that are not reported in the registry record.

13. Why This Trial Matters Statistically

Statistically, the study raises a practical question about how to evaluate a specimen-collection technique when participants undergo multiple passes and more than one specimen type is considered. The registry describes four passes per participant, with standard-needle passes and core-needle passes assigned different analytic purposes. This makes the distinction between participant-level outcomes and pass-level observations important.

In general, repeated samples from the same participant may be statistically dependent. A sound analysis needs to reflect whether the outcome is defined for each pass, each specimen, or each participant, and how those observations are combined. The record's participant-count endpoint and multi-pass procedure make that distinction relevant, yet the analysis method is not reported.

The entry also highlights the importance of clear reporting about design and allocation. A single-group label and NA allocation appear alongside a description of assignment to SST or CST groups. Readers need an unambiguous account of which comparisons were planned, how participants entered groups, and which observations contributed to each endpoint before they can interpret comparative estimates.

Finally, a clearly defined adequacy criterion is useful, but results require counts, denominators, and uncertainty measures to be interpretable. Without those, readers cannot distinguish a potentially meaningful difference from an imprecisely estimated one. This registry record therefore illustrates how a detailed procedural description can coexist with substantial gaps in statistical reporting. It identifies the question, but does not provide the numerical results needed to answer it.

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 for interpreting this trial from the registry entry is the absence of the primary diagnostic adequacy results. The record does not report counts, denominators, effect estimates, confidence intervals, p-values, or any of the listed analyses. As a result, the comparative findings and their precision cannot be assessed.

The design description is not fully consistent. The record labels the model as single group and allocation as NA, while also describing random assignment to SST or CST groups for the 22-gauge core-needle passes. It does not explain this difference or provide enough detail to classify the comparison more specifically. The registry's note that this is not a randomized, like-for-like control comparison is another reason not to treat the entry as a conventional randomized trial.

The endpoint description and procedure involve multiple passes and both cytologic and histologic material, but the record does not state how outcomes across passes were combined, how participants with multiple specimens were classified, or whether observations were analyzed at participant or pass level. It also does not report the analysis populations, missing-data handling, or any multiplicity plan for the related comparisons.

Other details that would inform interpretation are not reported in the registry record, including eligibility criteria, participant characteristics, protocol-based sample-size justification, interim analyses, and the statistical analysis plan. The adverse-event tabulation lacks information about observation duration and collection methods. These limitations concern what can be evaluated from this registry entry; they do not establish what was or was not done outside the record.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Comparison of a Novel 22-gauge Core Biopsy Needle — NCT01598194.
• Registry record last updated 2018-12-27; status last verified 2018-12.
• Results first posted 2018-12-27.
• 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.

18. Record Summary

The completed prospective study, sponsored by M.D. Anderson Cancer Center, lists an enrollment of 60 and concerns a 22-gauge reverse-bevel core biopsy needle for solid pancreatic lesions. The described procedure includes standard 25-gauge FNA passes and 22-gauge core-needle passes using SST or CST. The primary question concerns diagnostic adequacy with the core needle under the two suction techniques; a secondary outcome addresses single-pass cytologic adequacy compared with a standard 25-gauge needle.

The registry defines adequacy as obtaining cytological aspirates or histological core tissue sufficient for diagnostic interpretation. It describes four passes per participant, but does not report the adequacy results or statistical analyses. The design labels and group-assignment description are not reconciled in the record. Posted adverse-event figures show zero serious events, other events, and deaths in each listed group, with 30 participants at risk per group. These figures are limited to the registry tabulation and do not constitute a complete safety assessment.