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 Adjuvant Intraperitoneal Gemcitabine for Resectable Pancreatic Adenocarcinoma (NCT01206296), a na phase 2 study. The primary outcome is Grade III and IV Complications.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01206296 |
| Phase | Phase 2 |
| Condition | Pancreatic Adenocarcinoma |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 9 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Medstar Health Research Institute |
| Results posted | Yes |
2. Clinical Question
Population
Patients with resectable pancreatic adenocarcinoma. The registry record describes the study population in those terms, but it does not report participant characteristics or the number who ultimately received treatment. The recorded enrollment was 9.
Intervention
Intraperitoneal gemcitabine administered intraoperatively and postoperatively as adjuvant treatment. The registry record identifies the intervention but does not provide study data describing the treatment actually received or its delivery.
Comparator
There was no comparison group: the study is recorded as a single-group study, with allocation listed as not applicable and masking listed as none. Consequently, the study does not provide a direct treatment-versus-control comparison.
Primary question
The primary question was whether grade III and IV complications related to intraoperative intraperitoneal gemcitabine occurred during hospitalization or within 30 days of surgery, whichever period was longer. The registry record does not report the outcome data needed to answer that question.
The study also listed secondary objectives concerning overall survival at 2-years, patterns of disease recurrence, gemcitabine pharmacology, and changes in peritoneal cytology with pancreatic cancer resection. These are stated objectives, not reported findings. The registry record says the study was terminated and that no study data are available. Therefore, neither the primary safety question nor the secondary questions can be evaluated from the posted results. The absence of results is not evidence that complications did or did not occur, and it does not establish the effectiveness or ineffectiveness of the regimen.
3. Trial Design
This was a phase 2 study of adjuvant intraperitoneal gemcitabine for resectable pancreatic adenocarcinoma. Its design is recorded as single-group, with allocation not applicable and masking absent. The record lists 9 participants enrolled. Because there was no control group, the planned observations would have described outcomes among people receiving the study regimen rather than estimating a randomized contrast between treatment strategies.
The intervention is described as intraperitoneal gemcitabine given intraoperatively and postoperatively. The primary objective was to evaluate overall safety, with a specified outcome of grade III and IV complications related to intraoperative administration. The stated observation period continued during hospitalization or until 30 days after surgery, whichever was longer. Secondary objectives included overall survival at 2-years, recurrence patterns, pharmacology, and changes in peritoneal cytology.
The study status is terminated. The registry record lists a start date of 2010-08 and a primary completion date of 2014-02. It also states that the principal investigator had left the institution; attempts to contact the investigator or study team and to obtain data through publications, IRB, and RedCap systems were unsuccessful. The record reports that no study data are available.
Details such as eligibility criteria beyond resectable pancreatic adenocarcinoma, the treatment schedule, follow-up procedures, and the reasons for termination are not reported in the registry record. The record also does not provide a control-based design or a reported statistical analysis plan. The single-group structure limits what could be learned even if outcome data were available: outcomes could be described in the treated participants, but the design alone would not separate treatment effects from other explanations for those outcomes.
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 | Intraperitoneal Gemcitabine |
|---|---|
| STARTED | 0 |
| COMPLETED | 0 |
| NOT COMPLETED | 0 |
Analysis population for the primary outcome, as defined in the registry: The study was terminated and the PI has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful. Additional efforts were made to obtain study data via publications, IRB and RedCap systems. No study data are available.
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.
Population: The study was terminated and the PI has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful. Additional efforts were made to obtain study data via publications, IRB and RedCap systems. No study data are available.
| Characteristic | Unit | Intraperitoneal Gemcitabine |
|---|---|---|
| Participants analysed | 0 | |
| Age, Categorical: <=18 years | — | |
| Age, Categorical: Between 18 and 65 years | — | |
| Age, Categorical: >=65 years | — | |
| Sex: Female, Male: Female | — | |
| Sex: Female, Male: Male | — | |
| Region of Enrollment: United States | participants | — |
6. Primary Endpoint
The registry lists the primary outcome as Grade III and IV Complications, measured over Occurring during hospitalization or within 30 days of surgery, whichever is longer.
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the incidence of grade III and IV complications related to intraoperative intraperitoneal gemcitabine. The specified time window is during hospitalization or within 30 days of surgery, whichever is longer. In general, a complication endpoint of this kind is intended to capture serious postoperative events during a defined period, rather than every symptom or event of any severity. Restricting the endpoint to specified grades and linking it to the intervention also makes clear which events the study intended to count.
To interpret an incidence measure, readers would need the number of eligible participants assessed, the number who experienced qualifying complications, and a clear account of how event severity and relation to treatment were determined. An estimate of incidence would describe the frequency of the specified outcome in the study population. Its precision would depend in part on the amount of observed information, and a confidence interval would communicate uncertainty around the estimate. These are general statistical principles, not methods reported as having been used in this study.
The registry record gives the endpoint definition but no event count, denominator for the endpoint, estimate, or confidence interval. It explicitly states that no study data are available. The incidence of the primary endpoint is therefore not reported in the registry record, and the endpoint cannot be evaluated from the posted results.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a safety-focused primary endpoint but does not report its result. It states that no study data are available after efforts to contact the study team and seek data through publications, IRB, and RedCap systems. As a result, there is no reported count of grade III and IV complications, no endpoint denominator, and no estimate of incidence or its precision. The primary safety question remains unanswered in this record.
The enrollment is recorded as 9, but enrollment alone is not an outcome. It does not show how many participants received the intervention, had surgery, completed the observation period, or had complications. Those details are not reported in the registry record. The adverse-event entry lists zero participants at risk for serious and other events and zero affected participants, while also listing no serious-event terms. Given the explicit statement that no study data are available, those zero entries cannot be interpreted as evidence that no adverse events occurred. They do not replace an outcome report with a defined denominator and ascertainment details.
The study had no control group. Even if its outcome data were available, a single-group description would not directly show how outcomes compared with an alternative treatment or with no study intervention. It could describe observed events in the study participants, but a causal treatment comparison would require evidence that this design does not provide. This is a general limitation of single-group designs, not a claim about what happened to participants in this study.
The listed secondary objectives also have no reported results. The registry record does not provide overall survival findings, recurrence data, pharmacology results, or cytology changes. Their inclusion as objectives should not be mistaken for evidence that the outcomes were measured successfully or that findings favored any interpretation.
Statistical precision cannot be judged because there is no reported endpoint estimate or interval. No inferential analysis or p-value is reported in the registry record. These absences mean that the posted record cannot establish either the frequency of the targeted complications or the strength of evidence about the regimen. They should be read as missing results, not as positive or negative clinical findings.
9. Statistical Methods Explained
What does an incidence measure describe?
In general, an incidence proportion describes the share of a defined group that experiences a specified event during a defined observation period. Its interpretation depends on both parts of that definition: who is included in the group and what qualifies as an event. For this study, the intended event was a grade III or IV complication related to intraoperative intraperitoneal gemcitabine, and the stated period was hospitalization or within 30 days of surgery, whichever was longer. The registry record does not give the event count or endpoint denominator, so no incidence estimate can be interpreted.
Event classification also matters. A report would ideally make clear how complication grades were assigned, how relation to the intervention was judged, and whether events were actively collected or obtained from routine records. These are general considerations for interpreting a safety endpoint. The registry record does not report the procedures used to identify, grade, or attribute complications. Without those details and the underlying outcome data, readers cannot assess consistency of ascertainment or reproduce an estimate.
What would a confidence interval add?
In general, a confidence interval gives a range of values compatible with an estimate under the statistical method used. It communicates uncertainty that a point estimate alone does not convey. A narrow interval generally reflects greater precision than a wide interval, while the actual interpretation also depends on the design and assumptions. A confidence interval is not a guarantee that the true value lies within a particular interval, and it does not correct problems such as missing outcomes or biased event ascertainment.
No interval or endpoint estimate is reported in the registry record. Accordingly, there is no basis for describing the precision of the complication incidence. The recorded enrollment of 9 does not itself provide a precision estimate: precision would require the outcome observations and a stated calculation method. This is a general statistical point and does not imply that any particular method was used in the study.
How does a single-group design shape inference?
In general, a single-group study can report observed outcomes among participants who receive an intervention. It does not directly compare those outcomes with a concurrent control group. Changes or events may reflect multiple influences, including the underlying condition, surgery, other care, and the intervention. A comparison group can help distinguish treatment-related differences from those influences when the design and analysis support a valid comparison. Here, the registry record lists a single-group model and no allocation, so no comparative treatment effect is reported.
The primary endpoint refers to complications related to intraoperative gemcitabine, but an endpoint definition is not a statistical method for establishing causation. Determining whether an event is related to an intervention depends on clinical and study procedures that are not described in the registry record. Even a complete single-group event count would be descriptive unless further assumptions or a suitable comparison supported stronger inference.
What analysis can be identified?
The registry record reports no analyses and no study data. It does not report a statistical analysis plan, an estimate for the primary endpoint, a confidence interval, a p-value, or an adjusted model. It is therefore not possible to identify an analysis method actually applied to the clinical outcomes. Describing a proportion, interval, regression model, or test as the study's method would go beyond the record.
General planning calculations and analyses of observed outcomes answer different questions. A planning illustration uses assumptions to explore how much information might be needed for a specified target; it is not an observed result and does not establish what the study was designed to achieve. Any planning illustration associated with the record should not be read as the trial's own design justification or as evidence about treatment effects. No sample-size justification is reported in the registry record, and no clinical outcome data are available from which to interpret an observed effect.
Likewise, statistical significance and clinical importance are distinct concepts in general. A p-value, if reported, would assess compatibility of data with a statistical model and null hypothesis; it would not measure the size or practical importance of an effect. An interval would help convey magnitude and uncertainty. Neither is available for this study's outcomes. Since the record contains no outcome analysis, no conclusion about statistical significance, effect size, or precision can be drawn.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists one primary outcome and several secondary objectives: overall survival at 2-years, patterns of recurrence, pharmacology, and changes in peritoneal cytology. It does not report results for these objectives. It also does not report a statistical analysis plan describing how outcomes would be analyzed or how multiple questions would be handled. Whether any formal multiplicity adjustment was planned or used is not reported in the registry record.
In general, evaluating multiple outcomes or repeatedly testing hypotheses can increase the chance of finding an apparently notable result by chance. A prespecified analysis plan can clarify which outcome is primary, how secondary outcomes will be treated, and whether adjustment or a hierarchy of tests is intended. Those considerations cannot be assessed for this study from the available record. The existence of several stated objectives does not establish that statistical tests were performed.
The registry record says that no study data are available. It does not provide outcome denominators, missing-outcome counts, participant flow, follow-up completeness, or analysis populations. It is therefore not possible to determine whether participants were analyzed according to enrollment, treatment received, availability of outcome assessment, or another rule. The record also does not state how missing observations would have been handled.
In general, missing data can affect both the estimate and its precision, especially when the chance of missingness is related to participants' outcomes or characteristics. The record does not provide enough information to evaluate that possibility. The absence of results must not be taken as evidence of complete follow-up, absence of events, or a particular analysis population. These aspects of multiplicity and missing-data handling are not reported in the registry record.
11. What the Result Does, and Does Not, Mean
The record establishes that a phase 2, single-group study of intraperitoneal gemcitabine was registered for resectable pancreatic adenocarcinoma, that enrollment was recorded as 9, and that the study was terminated. It also identifies a primary safety endpoint and states that no study data are available. Those are statements about the record and its status, not findings about participants' health outcomes.
The record does not establish the incidence of grade III and IV complications, overall survival, recurrence patterns, pharmacology, or changes in peritoneal cytology. It reports no estimates or uncertainty intervals for these outcomes. The missing result cannot be interpreted as no complications, no change, or no effect. Nor does the trial establish that the intervention is beneficial or harmful. No medical conclusion should be inferred from the absence of posted data.
The single-group design also means that the study does not provide a direct comparison with another treatment or a control condition. In general, observed outcomes in a single group cannot by themselves distinguish the influence of an intervention from other factors. This design limitation is separate from the lack of reported data: even a descriptive result would not automatically support a comparative causal conclusion.
The appropriate interpretation is therefore narrow. The registry record documents study objectives and design features, but it does not provide evidence with which to estimate the stated clinical outcomes. The recorded enrollment does not fill that gap, and the adverse-event counts of zero at risk and zero affected cannot be treated as evidence of zero events when the record explicitly says no study data are available. Any stronger interpretation would exceed what the record reports.
12. Why This Trial Matters Statistically
This study is statistically notable because it illustrates the difference between a stated objective and an interpretable result. A registry can identify a clinically important endpoint and its observation window, but an endpoint definition alone does not supply an event count, a denominator, an estimate, or a measure of uncertainty. Without those elements, readers cannot quantify the outcome or judge its precision.
The single-group design also highlights the distinction between describing outcomes and comparing treatments. In general, a group can be followed to document events, but a control group is needed for a direct treatment contrast. Even with complete observations, design and analysis determine how far conclusions can go. Here, there are no posted outcomes to describe and no comparison group in the recorded design.
The record also shows why registry status and data availability need careful interpretation. The study is marked terminated, and the record explains that efforts to recover data were unsuccessful. That administrative history explains why results are absent; it does not reveal what the unreported results would have been. The zero entries in the adverse-event listing likewise should not be mistaken for a completed safety analysis when the record says that study data are unavailable.
For clinical researchers and biostatisticians, the central lesson is about evidentiary limits. Enrollment, endpoint definitions, and stated objectives do not substitute for observed outcomes and documented analysis methods. Transparent reporting of participant flow, outcome ascertainment, denominators, estimates, and uncertainty is necessary for statistical interpretation. In this record, the absence of those data makes the most defensible conclusion that the registered clinical questions remain unanswered by the posted results.
13. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The most consequential limitation is the absence of study data in the registry record. The record explicitly states that data were unavailable despite attempts to contact the principal investigator or study team and to obtain information through publications, IRB, and RedCap systems. Consequently, neither the primary safety endpoint nor the stated secondary objectives can be evaluated.
The enrollment of 9 is recorded, but the record does not describe participant flow, treatment receipt, the endpoint denominator, follow-up, or reasons participants may not have contributed outcome information. The small recorded enrollment also means that, even if outcomes were reported, estimates could be imprecise; the actual degree of precision cannot be assessed without outcome data and an analysis method. No precision estimate is reported in the registry record.
The single-group design provides no direct control comparison. The record lists allocation as not applicable and masking as none. It does not report procedures for outcome adjudication, complication grading, or assessment of relation to the intervention. These missing details limit assessment of potential ascertainment and interpretation issues, although the lack of outcomes is the immediate barrier to statistical evaluation.
The study was terminated, but the reason for termination is not reported in the registry record. The record does not report a statistical analysis plan, sample-size justification, missing-data approach, analysis populations, or handling of multiple outcomes. The secondary objectives are listed without results. These limitations are specific to the information recorded for this study and should not be replaced by assumptions about the protocol or the unreported findings.
14. Related Tutorials
15. Related Statistical Calculators
16. Sources
- ClinicalTrials.gov: Adjuvant Intraperitoneal Gemcitabine for Resectable Pancreatic Adenocarcinoma — NCT01206296.
- Registry record last updated 2021-03-09; status last verified 2021-02.
- Results first posted 2021-02-10.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
17. Record Summary
NCT01206296 is a phase 2, single-group study of intraperitoneal gemcitabine given intraoperatively and postoperatively as adjuvant treatment for resectable pancreatic adenocarcinoma. The recorded enrollment is 9. The primary objective concerned overall safety; the listed primary endpoint was grade III and IV complications related to intraoperative gemcitabine during hospitalization or within 30 days of surgery, whichever was longer.
The study is marked terminated. Its recorded start date is 2010-08, and its primary completion date is 2014-02. Secondary objectives concerned overall survival at 2-years, recurrence patterns, pharmacology, and peritoneal cytology. The registry record states that no study data are available after unsuccessful efforts to obtain them. It reports no outcome estimates or analyses; the clinical questions therefore remain unanswered by the posted results.