Secretin (ChiRhoStim) Pancreas Perfusion for Pancreatic Adenocarcinoma: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Secretin (ChiRhoStim) Pancreas Perfusion for Pancreatic Adenocarcinoma (NCT00587132), a non-randomized phase 1, phase 2 study. The primary outcome is Number of Subjects With Evidence of Pancreatic Tumor or Any Secondary Findings of Pancreatic Tumor as Shown by CT..

2. Clinical Question

The central statistical question is whether the post-secretin CT identified findings that were not evident on the prior normal CT, using the outcome definition in the registry. The endpoint includes a low-attenuation mass as evidence of a pancreatic tumor, and secondary findings such as a dilated pancreatic duct or liver masses suggestive of liver metastases. The registry does not report an analyzed count of participants with these findings, an estimate of test performance, or uncertainty around an estimate. Consequently, the record cannot establish how often the test produced a positive finding in this study or how precisely any such frequency might have been estimated.

The study was intended to evaluate a diagnostic imaging approach, not to compare secretin with a control treatment. Its different risk groups are not randomized comparison groups. The data therefore do not support causal claims about secretin relative to another imaging strategy or about differences among the listed groups. The practical statistical question remains unanswered in the posted results because the study ended early and no primary-outcome analysis was done.

3. Trial Design

The registry describes a pilot study using secretin, iodinated intravenous contrast, and 64-channel CT in patients at high risk for pancreatic adenocarcinoma. It lists Phase 1 and Phase 2, a parallel model, non-randomized allocation, and no masking. The intervention is synthetic human secretin. In the arm descriptions that give the administration details, participants receive a one-time dose of 0.2mcg/kg before CT imaging on Day 1.

The listed groups reflect different eligibility characteristics: new-onset diabetes, familial pancreatic cancer, Peutz-Jeghers syndrome, and suspicious clinical symptoms with a normal contrast-enhanced abdominal CT within 2 weeks. The familial-risk description specifies two or more first-degree relatives with pancreatic cancer; the descriptions for the syndrome and symptom groups specify ages 35-99. The new-onset diabetes description begins with adults diagnosed within two years and includes several qualifying features, but the description is cut off in the registry record. Full eligibility criteria for that group are not reported in the registry record.

The registry reports enrollment of 4 and status as terminated. It also states that the study was terminated early due to lack of funding and that no analysis was done due to low enrollment. The primary-outcome population description says all subjects had a normal CT scan. The posted record does not provide an analyzed flow of participants through screening, secretin administration, CT, and outcome assessment, so the number contributing to the primary outcome cannot be established from an analysis.

Because allocation was non-randomized, the listed groups are not interchangeable arms in a controlled comparison. Any differences between them could reflect their underlying clinical characteristics, and the registry reports no analysis comparing the groups. The masking status is none. The registry does not report a detailed statistical plan, a sample-size justification, interim analyses, or a fuller account of how imaging interpretations were performed.

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

Analysis population for the primary outcome, as defined in the registry: All subjects had a normal CT scan. The study was terminated early due to lack of funding. No analysis was done due to the low enrollment.

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 Number of Subjects With Evidence of Pancreatic Tumor or Any Secondary Findings of Pancreatic Tumor as Shown by CT., measured over Day 1 of study.

The primary outcome is the number of subjects with evidence of a pancreatic tumor or any secondary findings of a pancreatic tumor on CT, assessed on Day 1 of the study. The registry defines evidence of a tumor as a low-attenuation mass. Examples of secondary findings are a dilated pancreatic duct or liver masses suggestive of liver metastases. Subjects receive the secretin test dose just before the CT scan.

This outcome is used to describe whether secretin-enhanced CT identifies imaging findings of interest in the study population. In general, a count of participants with a defined finding is a direct way to report how often that finding was observed in the assessed group. It is not, by itself, a complete measure of diagnostic accuracy: interpreting accuracy would also require information about the reference standard and how positive and negative findings corresponded to disease status. Those details are not reported in the registry record.

The record states that all subjects had a normal CT scan, but it does not report a primary-outcome count or analysis. It also says no analysis was done because enrollment was low. Thus, the endpoint definition is available, but the posted results do not establish how many subjects had a qualifying finding on the secretin-enhanced CT. No estimate of diagnostic performance or precision can be derived from the reported primary outcome.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes a non-randomized, unmasked, parallel pilot study. It identifies the primary outcome as a number of participants with a defined imaging finding and states that no analysis was done because of low enrollment. The registry record does not report a statistical analysis plan, inferential methods, or planned handling of incomplete outcome data. The explanations below distinguish general statistical concepts from methods actually reported for this study.

What does a participant count represent?

For a binary outcome, each assessed participant can be classified as having or not having the defined event. A count reports how many participants fall into the event category. A rate or proportion would also require a denominator: the number of participants whose outcome was assessed. The registry gives an enrollment figure, but does not report an analyzed primary-outcome count or denominator. Enrollment alone should not be substituted for the number with an evaluable scan or a complete outcome assessment.

In general, a count is easiest to interpret when the outcome definition, assessment method, time point, and denominator are clear. Here, the registry defines the imaging findings and gives Day 1 as the time frame. However, the primary result is not analyzed, and the record does not describe an adjudication process or a reference standard for confirming whether a CT finding represented pancreatic cancer. The outcome definition therefore explains what was to be counted, but cannot replace the missing result.

What does non-randomized allocation imply?

In general, random allocation helps balance measured and unmeasured participant characteristics between groups, on average. With non-randomized allocation, groups may differ in the features that led participants to qualify for them. In this study, group labels correspond to different risk factors or clinical presentations. They are not described as assigned alternatives to secretin. A comparison of these groups would therefore not be a randomized treatment contrast, and the registry reports no such analysis.

The parallel model indicates that the study lists separate groups, but does not by itself establish that those groups form a valid comparative design. The record gives no control intervention and identifies no like-for-like control comparison. General statistical cautions about confounding and comparability apply, but the registry does not report an adjusted analysis that could address such differences. It would not be appropriate to attribute any hypothetical difference in findings to secretin or to a group characteristic on the basis of this record.

How should precision be understood?

In general, a confidence interval pairs an estimate with a range of values compatible with the data under the method used. Wider intervals indicate less precision, while narrower intervals indicate greater precision. A small amount of observed information commonly limits precision, but no confidence interval or primary-outcome estimate is reported in this record. It is therefore not possible to quantify precision for detection findings. No p-value or statistical test for the primary outcome is reported either.

The registry includes planning assumptions describing an illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. Such assumptions describe planning calculations, not an analysis of this study's primary endpoint. The record does not report a calculated planning result in the registry record, nor does it identify those assumptions as the trial's original design justification. The actual design is non-randomized, and the listed groups are not a like-for-like two-arm comparison. A planning illustration must not be interpreted as observed power or as evidence that a study result was statistically persuasive.

Why might over-dispersion matter in other outcome settings?

In general, over-dispersion means that observed variability is greater than a model expects. It can make standard errors and uncertainty estimates too small if the model does not account for that extra variation. This concept is relevant to some count outcomes, but the primary measure in this record is a participant count for a binary finding, and the registry does not report a fitted model or an over-dispersion assessment. No claim about over-dispersion or a model adjustment can be made for this study.

What can be inferred from zero adverse-event counts?

In general, observing no recorded events in a group does not establish that the underlying risk is zero. Interpretation depends on the number assessed, the observation period, the completeness of reporting, and how events were defined and collected. The adverse-event entries give the number at risk and the number affected for the New Onset Diabetes group, but the registry does not provide further detail about ascertainment, follow-up duration, or missing safety data. The zero counts should therefore be read narrowly as registry entries, not as a precise estimate of the chance of harm.

Overall, the record supplies an endpoint definition and basic design characteristics, but not the inferential analysis needed to estimate the primary result. The registry does not report model specifications, covariate adjustment, subgroup analysis methods, missing-data methods, or multiplicity procedures. Those methods should not be assumed from the study phase, the outcome type, or the planning assumptions.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("New Onset Diabetes")
n      <- c(4)
events <- c(0)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  New Onset Diabetes  4  0  0.0  0.0  60.2  0.0  49.0  0.5  52.2

11. Multiplicity, Missing Data and Analysis Populations

The registry lists one primary outcome measure and reports zero analyses. It does not describe an analysis plan or state whether any secondary outcomes were planned. Procedures for controlling multiplicity across endpoints, comparisons, subgroups, or repeated looks at the data are not reported in the registry record. Since no primary-outcome analysis is reported, there is no set of reported statistical tests whose multiplicity can be evaluated.

Missing-data handling is also not reported in the registry record. The record does not give a participant flow showing how many people were screened, received secretin, completed CT, or had an interpretable scan. It does not state whether all enrolled participants contributed to the primary outcome or whether any outcome assessments were unavailable. The enrollment figure should not be taken as a confirmed primary-outcome denominator.

The outcome population description says all subjects had a normal CT scan, and the record attributes the absence of analysis to low enrollment. It does not provide a definition of the analysis population, such as a prespecified set of participants with completed imaging. It also does not report an approach for handling indeterminate scans or incomplete assessments. These details are not reported in the registry record, so the effect of missingness on any intended outcome estimate cannot be assessed.

The registry does not report interim analyses, stopping rules, or a statistical plan for early termination. It states that the study was terminated early due to lack of funding. The reason for termination is reported, but the analytical consequences, including any planned adjustment for interim looks, are not described. No unreported procedure should be presumed.

12. Safety Results

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

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 5% reporting threshold.

The adverse-event record lists the New Onset Diabetes group with 4 at risk, zero serious adverse events, and zero other adverse events. The other listed groups each have zero at risk in these entries, with zero affected recorded. These are registry counts, not a comparison of safety between randomized treatment groups.

The zero counts mean that no serious or other adverse events are recorded for the listed group entry. They do not establish that the true event risk is zero or that every possible event was detected. The record does not report the duration of safety follow-up, the method of event collection, or a detailed definition of the event categories. Death counts are not reported in the registry record.

These safety entries should be interpreted separately from the primary imaging outcome. They do not indicate whether secretin-enhanced CT detected a tumor finding, and they do not fill the gap left by the unanalysed primary endpoint. The registry reports low enrollment and early termination, so the safety counts have limited descriptive scope.

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

The record documents a pilot study intended to test whether secretin-enhanced CT might be a useful noninvasive screening tool for a high-risk population. It specifies the primary imaging outcome and describes four risk or symptom-based groups. It also reports non-randomized allocation, no masking, enrollment of 4, early termination due to lack of funding, and no analysis because enrollment was low.

What the posted results do not show is whether any participant had a low-attenuation mass, a dilated pancreatic duct, or another listed secondary finding after secretin. No analyzed outcome count, estimate, confidence interval, or statistical test is reported. The record therefore neither demonstrates detection nor establishes that the test failed to detect relevant findings. An unreported result is not the same as a negative result.

The design also does not support a comparative claim about secretin versus another diagnostic approach. No randomized control is described, and the listed groups are not comparable treatment arms. Because the registry reports no analysis, there is no basis in the posted results to attribute differences in imaging findings to the intervention, should such differences have been observed.

The adverse-event entries record zero serious and zero other events for the group with 4 at risk. That is a limited description of the registry safety data, not proof of no risk. Information about safety follow-up and ascertainment is not reported in the registry record.

In short, the study record describes an intended diagnostic evaluation but does not provide the primary outcome analysis needed to judge its findings. It cannot establish diagnostic performance, comparative effectiveness, or a definitive safety profile. The appropriate statistical reading is that the question remains unanswered in the posted results, rather than that the study produced a positive or negative test result.

14. Why This Trial Matters Statistically

This trial matters statistically because it illustrates the distinction between a clearly stated research question and an answer supported by analyzed data. The registry defines a participant-level imaging endpoint and a Day 1 assessment after secretin, but reports no analysis of that endpoint. An outcome definition alone cannot establish how often a finding occurred or how precisely its frequency was estimated.

The record also highlights the importance of the denominator. Enrollment is reported, but there is no analyzed primary-outcome count or flow showing which participants had an evaluable scan. Without those details, a reader cannot calculate or interpret an outcome frequency. This is especially important in a diagnostic study, where assessment completion and the relationship between imaging findings and a reference standard shape what the results mean.

Design labels also matter. Non-randomized risk groups are not automatically valid comparators, and the different eligibility characteristics could make groups dissimilar. The record reports no group comparison, but the design details still prevent casual interpretation of the listed arms as a controlled trial. The lack of masking may also matter for outcome assessment in general; however, the registry does not describe image-reading procedures, so the influence of masking on interpretation cannot be assessed.

Finally, early termination and low enrollment define the limits of the record. The stated funding reason explains why the trial stopped, while the registry says no analysis was done because enrollment was low. Statistical interpretation must preserve that distinction: the study's intended question is not answered by a missing result. The record is therefore useful as an example of why transparent reporting of outcome counts, denominators, analysis populations, and uncertainty is essential, even when a trial does not reach an informative analysis.

15. 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 primary limitation is that no analysis of the primary outcome was done. The registry says this was due to low enrollment and reports that the study was terminated early because of lack of funding. As a result, there is no reported count of participants with qualifying CT findings, no denominator for an analyzed outcome, and no estimate of uncertainty.

The record reports enrollment of 4 but does not provide a participant flow or establish how many participants completed each study procedure. Although the primary population description says all subjects had a normal CT scan, it does not report the post-secretin imaging results or confirm the number with an evaluable primary outcome. The record also does not describe a reference standard for determining whether CT findings represented disease, which limits any assessment of diagnostic accuracy.

The study is non-randomized and unmasked, and its groups are defined by different risk or clinical features. No like-for-like control comparison is identified, and the registry reports no comparative analysis. The description of the new-onset diabetes group is incomplete in the registry record. The registry also does not report the imaging interpretation process, a statistical plan, a sample-size justification, interim analyses, missing-data procedures, or multiplicity handling.

Safety information is limited to the adverse-event entries. Follow-up duration, ascertainment methods, and detailed event definitions are not reported in the registry record; death counts are also not reported. These omissions mean the recorded zero event counts should not be treated as a complete or precise safety assessment. Together, these limitations leave the intended screening question unresolved in the posted results.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Secretin (ChiRhoStim) Pancreas Perfusion for Pancreatic Adenocarcinoma — NCT00587132.
• Registry record last updated 2013-06-24; status last verified 2013-06.
• Results first posted 2013-06-20.
• 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.

19. Record Summary

The registry describes a Phase 1 and Phase 2, non-randomized, unmasked, parallel pilot study of synthetic human secretin before CT in people at high risk for pancreatic adenocarcinoma. The listed groups are based on new-onset diabetes, familial pancreatic cancer, Peutz-Jeghers syndrome, or suspicious symptoms with a normal CT. The primary outcome is the number of subjects with tumor evidence or secondary findings on CT on Day 1.

The record reports enrollment of 4 and status as terminated. It states that termination was early due to lack of funding and that no analysis was done because enrollment was low. No primary-outcome count or analysis is reported. The adverse-event record lists zero serious and zero other events for the New Onset Diabetes group with 4 at risk; further safety follow-up details are not reported in the registry record.