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 An Analysis of Presentation and Outcome Following Treatment of Pancreatic Endocrine Neoplasms (NCT02400996), a registered phase not stated study. The primary outcome is Nonfunctioning and Malignant Pancreatic Endocrine Neoplasms.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02400996 |
| Phase | Phase not stated |
| Condition | Pancreatic Endocrine Neoplasms |
| Allocation | Not Stated |
| Design model | Not Stated |
| Masking | Not Stated |
| Enrollment | 40 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Medical College and Hospital Kolkata |
| Results posted | Yes |
2. Clinical Question
Population
Patients who underwent pancreatic surgery for pancreatic endocrine neoplasms. The registry records an enrollment of 40 and describes the study as a single-institution analysis. The population field for the primary outcome is empty, so further eligibility details are not reported in the registry record.
Intervention
No assigned intervention is described. The record concerns an observational analysis of patients who underwent pancreatic surgery; it does not define a treatment protocol or identify a particular surgical approach as an intervention to evaluate.
Comparator
No comparison group is reported. The record describes a single group of patients and does not support a like-for-like comparison between treatments or between treated and untreated patients.
Primary question
The stated outcome concerns the numbers of patients classified as having nonfunctioning or functioning tumours and benign or malignant lesions. The description says these classifications used clinical criteria, histopathological analysis, preoperative imaging and the WHO Classification of pancreatic endocrine tumours. The actual classification counts are not reported in the registry record.
The question is descriptive rather than a comparative treatment-effect question. The record concerns presentation and outcome following pancreatic surgery, but its stated primary measure is a count of tumour categories, not a defined contrast in clinical outcomes between treatment strategies. It says each participant was followed for a period of 5 years, while the primary endpoint description does not specify which follow-up events, if any, were counted. Outcomes observed during follow-up and their timing are not reported in the registry record.
The registry names pancreatic endocrine neoplasms as the condition and identifies the analysis as observational. The question that can be answered from the entry is therefore limited: it describes how the investigators intended to classify tumours among the operated patients. It cannot establish whether one treatment was better than another, or characterize the frequency of particular tumour categories, because the outcome counts and a comparator are not reported.
3. Trial Design
The registry marks the study as completed and records enrollment of 40. Its summary describes a single-institution study of pancreatic endocrine neoplasms over 18 years. The arm description, however, says the analysis used a prospectively maintained database of patients who underwent pancreatic surgery at Sir Ganga Ram Hospital, New Delhi, India from 1995 to 2013. The sponsor is listed as Medical College and Hospital Kolkata. The recorded study start and primary completion dates are 2011-03 and 2011-06. These descriptions do not explain how the study dates relate to the 18-year period or to the hospital named in the arm description; the relationship is not reported in the registry record.
The study is observational, with a single group labeled “Pancreatic Endocrine Neoplasms.” No random allocation, assigned treatment, or control group is described. The registry itself notes that this is not a randomized comparison and that the arms are not a like-for-like control comparison. The available description instead identifies patients who had pancreatic surgery and says investigators reviewed a maintained database, pathological reports, and preoperative CT scans.
The arm description ends with an incomplete phrase after saying that the investigators identified “4”. Its intended meaning is not reported in the registry record, so it cannot be used to infer an additional sample count, subgroup, or finding. The registry records one outcome measure and 0 analysis records. It does not report a prospective protocol, a statistical analysis plan, a sample-size justification for the study, or details of recruitment and follow-up beyond the stated period of 5 years for each participant.
Although the entry is marked completed, that status does not establish that every planned observation was collected or analyzed. Actual follow-up duration, completeness of outcome ascertainment, and the analysis population are not reported in the registry record. The study design supports descriptive interpretation only; it does not provide a basis for attributing differences in outcomes to a treatment.
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 | Patients Operated for Pancreatic Endocrine Neoplasms |
|---|---|
| STARTED | 40 |
| COMPLETED | 40 |
| 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 | Patients Operated for Pancreatic Endocrine Neoplasms |
|---|---|---|
| Participants analysed | 40 | |
| Age, Continuous | years | 48.6 (SD 15.52) |
| Sex: Female, Male: Female | Participants | 18 |
| Sex: Female, Male: Male | Participants | 22 |
| Region of Enrollment: India | participants | 40 |
6. Primary Endpoint
The registry lists the primary outcome as Nonfunctioning and Malignant Pancreatic Endocrine Neoplasms, measured over Each participant was followed up for a period of 5 years.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | participants |
| Endpoint classification | Binary Endpoint |
The primary outcome is titled “Nonfunctioning and Malignant Pancreatic Endocrine Neoplasms.” It is recorded as a number of participants. The accompanying description says that, among the 40 patients operated for pancreatic endocrine neoplasms, investigators identified functioning and nonfunctioning tumours using clinical criteria, histopathological analysis, and preoperative imaging as the gold standard. They also recorded benign and malignant lesions according to the WHO Classification of pancreatic endocrine tumours.
This outcome is intended to describe the clinical and pathological composition of the operated group. Classification can be useful in a descriptive study because it organizes patients according to tumour function and malignancy status. Those categories can help readers understand which kinds of neoplasms were represented in the surgical series. This general purpose does not make the endpoint a measure of treatment efficacy, and a count alone does not establish that any particular treatment caused an outcome.
The registry does not provide the actual number classified in each category, nor does it specify whether all categories were analyzed as separate outcomes or how ambiguous classifications were handled. The title combines nonfunctioning and malignant tumours, while the description also mentions functioning tumours and benign lesions. The exact endpoint structure and category-specific results are not reported in the registry record.
The stated follow-up period is 5 years for each participant, but the endpoint description does not connect that follow-up to a particular time-to-event or clinical outcome. It therefore should not be read as evidence that the classification counts represent events occurring during follow-up. The posted endpoint information describes what investigators intended to count, not the observed distribution.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry describes a completed observational analysis of patients undergoing pancreatic surgery for pancreatic endocrine neoplasms. Its stated primary outcome is a count-based classification of tumour function and malignancy. Although the record explains the intended classification approach, it does not report the number of participants in any category. Consequently, the primary outcome cannot be quantified from the registry entry, and no estimate of its precision can be assessed.
The distinction between an endpoint definition and an endpoint result is important. A definition tells readers what investigators planned to classify or count. A result gives the observed values, and an estimate of uncertainty indicates how precisely those values describe the underlying population. Here, the classification criteria are described, but the category counts, confidence intervals, and inferential results are not reported in the registry record. The entry also lists 0 analysis records, which means the registry does not provide an analysis result to interpret. It does not establish whether analyses were performed outside the registry.
The available safety information records 6 participants with serious adverse events and 16 with other adverse events, with 40 at risk in each record. The record lists pancreatic fistula at 15.0% among the serious adverse-event terms. These figures describe recorded safety counts; they do not establish that surgery caused the events, nor do they provide a comparison with another treatment or group. The denominator and method underlying the pancreatic fistula percentage are not reported in the registry record. Deaths are not reported in the registry record.
Because there is no comparator and no randomized allocation, the design cannot separate treatment effects from differences in patient characteristics, disease presentation, clinical decisions, or other factors. In general, observational descriptions can characterize the patients represented in a dataset, but causal conclusions require a design and analysis capable of addressing such differences. No adjusted analysis or methods for confounding are reported.
The entry states that each participant was followed for 5 years, but does not report actual follow-up completeness, censoring, or clinical outcome results over that period. The follow-up statement should therefore be read as a recorded timeframe, not as evidence that complete five-year outcomes are available for every participant. Overall, the registry supports a limited account of study intent and selected safety counts. It does not supply the primary classification results or a treatment-effect estimate.
9. Statistical Methods Explained
What kind of analysis is described?
The record describes an observational analysis using a prospectively maintained database of patients who underwent pancreatic surgery. In general, observational studies examine events or characteristics without assigning participants to treatment groups for the purpose of a randomized comparison. They can provide descriptive information about a clinical series, but treatment comparisons in such data may be influenced by why patients received particular care and by other differences between patients.
The registry labels this as a single-centre analysis, while the arm description names Sir Ganga Ram Hospital in New Delhi and the sponsor field names Medical College and Hospital Kolkata. The summary and arm description also give different context for the study period: the summary refers to 18 years, and the arm description gives 1995 to 2013. The relationship among these details is not reported in the registry record. The record gives study start and primary completion dates of 2011-03 and 2011-06, but does not explain whether these dates refer to data collection, registry administration, or another study activity.
What does a count endpoint tell the reader?
The primary measure is specified as a number of participants classified by tumour function and malignancy. In general, a count describes how many observations fall into a category. It does not by itself convey the uncertainty around that count, the representativeness of the study group, or the extent to which classification may be affected by missing information or judgement. A confidence interval, when reported, gives a range of values compatible with the data under a stated statistical model; its interpretation depends on the sampling process and assumptions. No confidence interval is reported for the primary outcome.
The endpoint description identifies clinical criteria, histopathology, preoperative imaging, and the WHO Classification as classification bases. It does not describe a formal adjudication process, rules for discordant assessments, or whether assessors were blinded to other information. Those procedures are not reported in the registry record. The label “gold standard” appears in the description for pathology and preoperative imaging, but does not supply the detailed operational rules needed to reproduce the classifications.
How should the safety counts be understood?
The registry records serious adverse events affecting 6 participants and other adverse events affecting 16 participants, with 40 at risk in each category. These are counts, not comparative effect estimates. In general, adverse-event counts need a clear definition of the event categories, observation period, and denominator to support interpretation. The record lists pancreatic fistula at 15.0% among the serious-event terms, but does not state the denominator or calculation details for that percentage. It also does not report death counts.
Serious and other adverse events are distinct registry classifications; the entry does not explain whether a participant could appear in both. It would therefore be inappropriate to combine the counts or infer a total number of participants with any event. Nor does the record describe event severity beyond the serious classification, timing, duration, or attribution to surgery. General safety interpretation should separate the occurrence of an event from a conclusion about its cause.
What do the planning illustrations represent?
The planning illustrations are based on the observed effect and use a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. They are illustrations for hypothetical future planning, not the design justification for this observational study. The record does not report a planned treatment contrast for the study itself, a study-specific sample-size justification, or an allocation procedure. The illustrations therefore should not be treated as evidence that this study was designed with a particular power.
In general, power is the probability that a planned statistical test will detect a specified effect under the assumptions of the design and analysis. A planning calculation can show how sample requirements depend on the effect one wishes to detect, the significance threshold, allocation, and statistical model. These calculations do not tell readers whether an observed result is true, and they are not “observed power.” The assumptions for the illustrations state that the target effect is a stated fraction of the observed effect, but no particular fraction or numeric planning result is needed to interpret the registry’s endpoint.
The general method note also distinguishes time-to-event illustrations, which use a total number of events, from other illustrations, which report participants per arm. That distinction concerns planning outputs rather than observed results. Since this study has no reported randomized arms or comparative analysis, those hypothetical planning quantities do not create a valid treatment comparison for the patient series.
What inferential methods are available?
The registry lists 0 analysis records and does not report a statistical analysis plan, adjustment methods, hypothesis tests, confidence intervals, or treatment-effect estimates. It is not possible to determine from the registry whether the investigators used any inferential methods outside the record. In general, an unadjusted comparison describes a contrast without accounting for other variables, while an adjusted analysis attempts to account for measured covariates according to a prespecified model. Neither approach can be attributed to this study from the information recorded.
General statistical interpretation also depends on the amount and structure of missing data, the definition of the analysis population, and whether repeated or clustered observations are present. These details are not reported. The record describes a participant count endpoint, but does not provide a data-level account of classification completeness or rules for participants with incomplete follow-up. Thus, neither a reproducible analysis nor an assessment of its assumptions can be made from the registry record alone.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists one outcome measure, titled “Nonfunctioning and Malignant Pancreatic Endocrine Neoplasms,” and 0 analysis records. It does not report a prespecified hierarchy of outcomes, a multiplicity adjustment, or a statistical analysis plan. The endpoint description includes more than one classification distinction: functioning status and benign or malignant status. The record does not explain whether these were analyzed as separate outcomes, combined categories, or descriptive counts. The structure of testing, if any, is not reported in the registry record.
In general, multiplicity arises when multiple outcomes or comparisons are examined. If many statistical tests are performed, the chance of finding an apparently unusual result can increase unless the analysis plan accounts for that situation. This is a general consideration, not a claim that multiple tests were conducted in this study. With no analysis records or reported inferential results, there is no basis for assessing whether multiplicity affected any conclusions.
Missing-data procedures are also not reported. The record states that each participant was followed for 5 years, but does not give follow-up completeness, the amount of missing outcome information, or how incomplete records were handled. The number of participants included in the endpoint analysis is not reported. Enrollment of 40 should not be assumed to equal the analysis population.
The registry does not specify an intention-to-treat population, a per-protocol population, or another analysis population. Given the observational design and absence of an assigned treatment comparison, those terms cannot be inferred from the record. No imputation, exclusion criteria for analysis, or sensitivity analysis is described. These omissions limit the ability to assess whether the endpoint counts, if reported elsewhere, would represent all enrolled participants or a subset with complete classification and follow-up.
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 |
|---|---|---|---|
| Pancreatic Endocrine Neoplasms | 6 | 40 | 15.0% |
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 |
|---|---|
| Pancreatic Endocrine Neoplasms | 16 of 40 |
Most frequent serious adverse event terms
| Event term | Organ system | Pancreatic Endocrine Neoplasms |
|---|---|---|
| Pancreatic fistula | Gastrointestinal disorders | 6 of 40 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Pancreatic Endocrine Neoplasms |
|---|---|---|
| Delayed Gastric Emptying | Gastrointestinal disorders | 8 of 40 |
| Wound Infection | Infections and infestations | 4 of 40 |
| Intraabdominal Abscess | Infections and infestations | 2 of 40 |
| Postoperative Fever | General disorders | 2 of 40 |
Serious events with the highest arm-level rate: pancreatic fistula (15.0%).
The safety record lists 40 participants at risk for serious adverse events and 6 affected by such events. It separately lists 40 at risk for other adverse events and 16 affected. These are registry counts, not evidence of a treatment contrast. The entry does not state whether the same participant could contribute to both categories, so the counts should not be added or interpreted as a count of unique participants with any adverse event.
Pancreatic fistula is listed among the serious adverse-event terms at 15.0%. The denominator and calculation details for that percentage are not reported in the registry record. The term listing does not provide the event’s timing, duration, severity beyond its serious classification, or attribution. The record does not report deaths.
In general, safety counts are most informative when the event definitions, observation period, denominator, and ascertainment procedures are clear. The registry states a follow-up period of 5 years for each participant in the primary outcome description, but does not explain whether that period applies to adverse-event collection or whether complete safety follow-up was achieved. The figures should therefore be read as the safety information recorded in the registry, not as a complete account of all possible harms or proof that an event was caused by surgery.
12. What the Result Does, and Does Not, Mean
The record documents an observational surgical series and an intention to classify pancreatic endocrine neoplasms by function and malignancy. It also provides selected safety counts. These details can help characterize what the registry entry says the investigators studied and what safety information was entered, but they do not provide the primary classification results. No count of functioning, nonfunctioning, benign, or malignant tumours is reported in the registry record.
The absence of a reported endpoint result means that the primary question cannot be answered quantitatively from this entry. It is not possible to assess the distribution of tumour categories, estimate uncertainty, or compare observed findings with another group. The registry lists 0 analysis records, but that does not demonstrate that no analysis occurred outside the registry. It means that analysis results are not available in the record.
The safety counts show that the registry recorded serious and other adverse events, and it identifies pancreatic fistula at 15.0% among serious-event terms. This does not establish causation, comparative safety, or a complete risk profile. The denominator for that percentage and the details of event collection are not reported. No treatment-control comparison is described, and the study is explicitly not a randomized comparison.
In general, a descriptive observational series can offer context about patients treated in a particular setting. It cannot, without an appropriate comparison and suitable analysis, isolate the effect of a treatment from patient selection, disease characteristics, clinical judgement, or other influences. The record does not report an adjusted treatment-effect analysis or a sample-size justification for a comparative question. Its planning illustrations are explicitly based on a hypothetical effect for future planning, not observed power for this study.
The listed follow-up period of 5 years describes the stated timeframe, but completeness and outcomes over that period are not reported. The study status is completed, yet that status does not fill in absent endpoint results or establish complete follow-up. The defensible interpretation is therefore narrow: the registry records the study’s observational focus, classification approach, and limited adverse-event information, while leaving the principal outcome distribution and its statistical uncertainty unavailable.
13. Why This Trial Matters Statistically
This record illustrates why a registry entry needs to be read as a record of study descriptions and results, not as a complete report of every analysis. The clinical topic is specific, and the endpoint description identifies meaningful tumour classifications. Yet the actual category counts are not reported, so the central descriptive question cannot be quantified. A clearly named endpoint is not equivalent to an available result.
The entry also shows how study context matters for interpretation. It is described as an observational analysis of patients undergoing pancreatic surgery, without a comparator or random allocation. That design can support descriptions of a clinical series but does not provide a randomized estimate of treatment effect. The record itself cautions that the groups are not a like-for-like control comparison. Avoiding a causal interpretation is therefore essential.
There are also differences among the recorded descriptions of study setting and timing: the summary refers to a single institutional study over 18 years, the arm description names Sir Ganga Ram Hospital and gives 1995 to 2013, and the sponsor is Medical College and Hospital Kolkata. The record does not reconcile these details. Such inconsistencies matter because setting and timeframe shape the population to which a descriptive result might apply.
Finally, the entry contains selected safety counts and a named serious adverse-event term, but does not report the denominator behind the term percentage or the completeness of safety follow-up. This makes the record useful for identifying what information was entered, while also making clear what cannot be concluded. The distinction between recorded counts, endpoint results, and causal evidence is central to sound interpretation of clinical research.
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 primary limitation is that the registry does not report the values for its stated primary outcome. Although it describes the classifications of functioning status and benign or malignant disease, it does not provide category counts or uncertainty estimates. The number of patients included in the endpoint analysis is also not reported. Enrollment should not be treated as proof that every enrolled participant contributed complete endpoint data.
The registry’s descriptions of setting and timing are not fully aligned. It calls the study a single-institution analysis over 18 years, while the arm description identifies Sir Ganga Ram Hospital in New Delhi and gives a period from 1995 to 2013. Medical College and Hospital Kolkata is named as sponsor. The relationship between the named sponsor, the hospital, and the study dates is not reported in the registry record. The arm description is also incomplete, ending after the phrase “identified 4”; no additional finding can safely be inferred from that fragment.
No comparator, randomization, treatment allocation, or adjustment strategy is reported. The observational design limits causal interpretation, and the record does not describe patient selection, eligibility criteria, baseline characteristics, or potential confounding factors in enough detail to evaluate comparability or generalizability. The population field for the primary outcome is empty.
Although the record states that each participant was followed for 5 years, actual follow-up completeness, losses to follow-up, endpoint ascertainment, and missing-data handling are not reported. The statistical analysis plan, multiplicity procedures, and analysis populations are also not reported. The registry lists 0 analysis records, so inferential results and their precision cannot be assessed.
Safety reporting is limited to counts and a serious-event term percentage. The event definitions, overlap between serious and other adverse-event categories, denominator for the percentage, attribution, timing, and death count are not reported in the registry record. These omissions prevent a complete safety interpretation.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: An Analysis of Presentation and Outcome Following Treatment of Pancreatic Endocrine Neoplasms — NCT02400996.
- Registry record last updated 2015-04-29; status last verified 2015-04.
- Results first posted 2015-04-29.
- 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
The registry identifies a completed observational study of pancreatic endocrine neoplasms, with enrollment of 40. Its summary describes a single-institution analysis over 18 years; the arm description refers to a prospectively maintained surgical database at Sir Ganga Ram Hospital, New Delhi, from 1995 to 2013. Medical College and Hospital Kolkata is listed as sponsor. The recorded start and primary completion dates are 2011-03 and 2011-06, and the relationship between these dates and the longer study period is not reported.
The primary measure concerns counts of tumour classifications by functioning status and benign or malignant status. The record says each participant was followed for 5 years, but does not report the classification counts, analysis results, or completeness of follow-up. It lists 0 analysis records and does not describe a comparator or randomized allocation.
Safety information records 6 participants with serious adverse events and 16 with other adverse events, with 40 at risk in each category. Pancreatic fistula is listed at 15.0% among serious-event terms; its denominator is not reported. Overall, the registry provides study and endpoint descriptions plus limited safety counts, but not the primary outcome results or an inferential estimate.