Electrochemotherapy of Posterior Resection Surface for Lowering Disease Recurrence Rate in Pancreatic Cancer (PanECT Study): Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Electrochemotherapy of Posterior Resection Surface for Lowering Disease Recurrence Rate in Pancreatic Cancer (PanECT Study) (NCT04281290), a na na study. The primary outcome is Incidence of Postprocedural Complications for Evaluation of Feasibility and Safety.

2. Clinical Question

The study aims to evaluate toxicity and effectiveness of electrochemotherapy with bleomycin in pancreatic cancer in clinical study phase I and II. Its proposed treatment is given after surgical resection, directly to the posterior resection surface. The stated rationale is to lower disease recurrence at that site. This rationale is a study objective, not evidence that recurrence was reduced.

The protocol description says treatment effectiveness would be assessed with ultrasound or CT imaging to detect early local recurrence, followed by clinical examination, laboratory tests, tumor markers, and imaging during follow-up. Disease-free survival and overall survival are listed as secondary outcomes. The registry record does not give outcome definitions, follow-up results, or numerical estimates for those secondary outcomes.

3. Trial Design

PanECT is registered as a single-group interventional study of electrochemotherapy after pancreatic cancer resection. Its allocation is listed as NA, and masking as none. The listed experimental group receives intraoperative electrochemotherapy following pancreaticoduodenectomy. There is no concurrent control group described, so the design does not directly compare outcomes under electrochemotherapy with outcomes under another treatment or usual care.

The intervention combines electroporation using the Cliniporator Vitae® with Bleomycin PHC 15 e. (United States Pharmacopeia - USP). The intended treatment site is the posterior resection surface. The registry identifies the sponsor as University Medical Centre Ljubljana. The phase field is recorded as NA, even though the study description refers to a clinical study phase I and II.

The registry enrollment is 10. The brief description says the study would include 10 patients in phase I and additional 10 patients in phase II, or in an extension of the clinical study, if they fulfilled inclusion criteria. The registry record does not clarify whether phase II or an extension was undertaken, nor does the enrollment entry establish that the planned additional patients were enrolled. The recorded status is active, not recruiting.

The recorded study start is 2020-07-13 and the primary completion date is 2023-05-08. The primary endpoint is incidence of postprocedural complications, with a timeframe of 7 days after operation. The study description specifies postoperative clinical examinations and blood tests on day 1, 3, and 7, with additional ultrasound or CT imaging if abnormalities are detected. Disease-free survival and overall survival are named as secondary outcomes. The registry record does not describe a comparator, randomization process, or masking beyond the design fields noted above.

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

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: All the enrolled patients were included in analysis.

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 Incidence of Postprocedural Complications for Evaluation of Feasibility and Safety, measured over 7 days after operation.

The primary endpoint is a count of participants with postprocedural complications, used to assess feasibility and safety. Its stated timeframe is 7 days after operation. The endpoint description says complications are to be recorded and reported in line with the Clavien-Dindo classification of surgical complications. It also says the study will assess whether a complication is related to electrochemotherapy or not.

The described monitoring includes clinical examination and blood tests, including a hemogram, comprehensive metabolic panel, and liver panel, according to the study protocol on day 1, 3, and 7 after operation. If an abnormality is detected, additional imaging with ultrasound and/or CT is to take place. This monitoring provides the clinical context for identifying postoperative complications; it does not, by itself, establish that a complication was caused by the procedure.

A participant count is a descriptive way to report how many people experienced the endpoint. In a single-group study, it can describe the observed safety experience in the enrolled group, but it cannot isolate the effect of electrochemotherapy from the effects of surgery, the underlying disease, or other influences. The registry record summarized for this trial gives the endpoint definition and analysis population, but does not report the primary endpoint count or its classification. The actual observed primary-endpoint result is therefore not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary outcome is a participant count: it concerns how many people experienced postprocedural complications during the specified 7 days after operation. For a binary outcome, each participant is classified according to whether the event occurred within the defined period, and the count describes the number classified as having the event. A percentage or event rate can be useful alongside a count, but no primary-endpoint percentage or count is reported in the registry record summarized for this trial. No new rate can be derived without the endpoint result.

The endpoint description specifies a follow-up approach that includes clinical examinations and blood tests on day 1, 3, and 7. Additional imaging is planned when abnormalities are detected. Complications are to be classified using the Clavien-Dindo classification, and their relationship to electrochemotherapy is to be assessed. These procedures indicate how information was intended to be collected and categorized. They do not replace a reported outcome count, and the registry record does not show the resulting classifications.

In general, a confidence interval gives a range of values compatible with the observed data under the method used. It communicates uncertainty as well as the point estimate. For an event count from a small single group, the estimate may be imprecise; the interval depends on the observed count and the method used. Neither a primary-endpoint confidence interval nor a confidence-interval method is reported, so the precision of that outcome cannot be evaluated from the registry record.

The registry identifies the study model as single group, with allocation NA and masking none. In general, a concurrent comparator can help distinguish treatment-associated differences from background events and other influences. A single-group design can describe what happened in the enrolled group, but it cannot provide that direct contrast. It is therefore important not to turn an observed event count into a treatment effect or to attribute every postoperative event to electrochemotherapy. The registry indicates that investigators intended to assess attribution, but does not report those judgments in the information summarized.

The record lists 0 analyses. No statistical analysis plan, method for handling uncertainty, or method for comparing outcomes is reported in the registry record. The phase field is NA, although the study description discusses phase I and phase II. The registry enrollment is 10, while the brief description refers to 10 patients in phase I and additional 10 patients in phase II or an extension. The record does not clarify how those stated plans relate to the registered enrollment or which phase was completed.

The named secondary outcomes are disease-free survival and overall survival. In general, a time-to-event analysis considers both whether an event occurred and how long participants were followed before the event or the end of observation. Such an analysis also requires clear definitions of the event, the time origin, follow-up, and how censoring is handled. Those details and the outcome estimates are not reported in the registry record summarized for this trial. The names of the outcomes alone are not enough to interpret survival results.

The registry notes 3 outcome measures. It names disease-free survival and overall survival as secondary outcomes and gives the postprocedural-complication count as primary. The record does not provide a multiplicity procedure or explain how multiple outcomes were prioritized in analysis. In general, when several outcomes are examined, a prespecified analysis plan helps clarify which results are confirmatory and how the risk of chance findings is handled. No such plan is reported.

Sample-size calculations are planning tools, not results from participants. The stated planning assumptions refer to a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect expressed as a fraction of an observed effect. These assumptions do not describe the registered single-group design and should not be read as evidence that a randomized two-arm comparison occurred. The record does not report a sample-size justification for the registered study, and no planning calculation is an observed power estimate.

In general, over-dispersion means that the variability in count data is greater than a chosen model expects. A model that ignores this can understate uncertainty. This concept is most relevant when a count model is used; the endpoint is described as a count of participants with complications, and the registry record does not report a count-model analysis. No particular modeling approach, adjustment, or variance method is reported. The numerical primary result is also absent, so there is no basis in the record for recalculating an estimate or its uncertainty.

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("Experimental Group")
n      <- c(10)
events <- c(4)
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  Experimental Group  10  4  40.0  12.2  73.8  16.8  68.7  16.7  69.2

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 3 outcome measures and names disease-free survival and overall survival as secondary outcomes. The primary outcome is incidence of postprocedural complications for feasibility and safety. No procedure for addressing multiple outcomes is reported in the registry record. That leaves unclear whether the named outcomes were intended to be treated as confirmatory, exploratory, or interpreted under a prespecified hierarchy.

Multiplicity matters in general because examining several outcomes can increase the chance that at least one result appears noteworthy by chance. A prespecified plan can state which outcomes are primary, how secondary results will be interpreted, and whether any adjustment is planned. The record identifies a primary endpoint and names secondary outcomes, but does not report a multiplicity adjustment or a broader statistical analysis plan. It also lists 0 analyses, so there are no posted inferential results to evaluate for multiplicity.

Missing-data handling is not reported in the registry record. The primary endpoint description says all enrolled patients were included in analysis, but it does not specify how missing assessments, incomplete follow-up, or unavailable laboratory or imaging information would be handled. That population statement should not be taken to mean that every planned measurement was obtained or that no data were missing.

The record does not report the number of participants with missing outcome data, reasons for missingness, or any sensitivity analysis. For the named survival outcomes, details about follow-up completeness and censoring are not reported. These omissions limit assessment of whether the available observations represent the intended follow-up for each outcome.

12. 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.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: pancreatic fistula (10.0%).

The registry's adverse-event figures concern the experimental group following pancreaticoduodenectomy. It records 10 participants at risk, 1 with a serious adverse event, 6 with other adverse events, and 7 deaths. The top serious term is pancreatic fistula, listed at 10.0%. These are the posted safety figures; the record does not give an event-level narrative or additional context in the information.

The serious-event count and other-event count should not be added together to create a total number of affected participants. The registry record does not say whether these categories overlap, and a person may be represented in more than one category. The death count is also listed separately; its timing, cause, relationship to treatment, and overlap with the adverse-event categories are not reported. The pancreatic fistula entry is identified as the top serious term, but the available information does not establish its relationship to electrochemotherapy.

These adverse-event figures are not the primary endpoint result. The primary endpoint concerns complications within 7 days after operation and uses the Clavien-Dindo classification, whereas the adverse-event listing is reported separately. Without timing, classification, and attribution details, the figures cannot be treated as a complete account of postoperative complications or as evidence of a causal relationship.

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

The study addresses an important clinical-research question: whether electrochemotherapy applied to the posterior resection surface after pancreatic cancer surgery can be evaluated for feasibility and safety, with the longer-term objective of lowering recurrence. Its design and monitoring description show how the investigators intended to assess postoperative complications and follow patients for recurrence and survival. They do not, by themselves, establish that the intervention changed any outcome.

The available record describes a single-group study and does not present a comparator. Even if a numerical event result were available, an event count in one group would describe that group's experience rather than establish what would have happened under another treatment. Surgical complications can have several possible influences, and the registry's endpoint description explicitly distinguishes whether a complication is related to electrochemotherapy or not. The reported adverse-event counts do not include the attribution details needed to make that distinction.

The registry does not report a numerical primary-endpoint result, a recurrence result, or results for disease-free survival and overall survival. Consequently, the stated goal of reducing recurrence remains an objective in the study description, not a demonstrated finding in the reported information. The serious adverse-event and death counts should be read as descriptive safety entries, without assuming timing, cause, overlap, or treatment relationship.

The registry lists enrollment of 10 and states that all enrolled patients were included in the primary-endpoint analysis population. It also describes plans for phase I and additional phase II patients or an extension, while the phase field is NA. The record does not clarify the relationship between those plans and the registered enrollment. These details matter when judging how much evidence a study can contribute, but they do not fill the gap in the absent outcome results.

In statistical terms, the reported information supports understanding the study question, design, endpoint definition, and selected adverse-event counts. It does not support an estimate of treatment effect, a comparison with usual care, or a conclusion about recurrence or survival. The registry record does not report the precision of the primary endpoint or a formal analysis with which to quantify uncertainty.

14. Why This Trial Matters Statistically

PanECT is statistically notable because it applies a local procedure after pancreatic cancer surgery and frames feasibility and safety as its primary focus. A clearly defined short-term complication endpoint can make an early-stage study informative about whether the intervention can be delivered and what postoperative events are observed. The registry describes clinical examinations, laboratory monitoring, imaging when abnormalities occur, and classification of complications using the Clavien-Dindo system.

The study also illustrates why endpoint definitions and results must be separated. The record sets out a 7-day timeframe and says investigators will assess whether complications are related to electrochemotherapy. Yet no numerical result for that primary endpoint is reported in the information summarized. Without the observed count and its classification, the endpoint's actual experience and precision cannot be assessed.

The single-group design is another key statistical feature. It can document events in the treated group, but it cannot directly estimate a contrast with a control group. This distinction is essential for interpreting safety as well as the study's longer-term aim of lowering recurrence. The registry names disease-free survival and overall survival, but does not report their results.

The study description refers to phase I and phase II objectives and a possible extension, while the registry phase field is NA and enrollment is recorded as 10. This illustrates the importance of distinguishing a planned enrollment description from what the registry records as enrollment and from what is available as analyzed results. The record also lists 0 analyses, so there are no posted statistical comparisons or uncertainty estimates to interpret.

Taken together, the registry record helps clarify what investigators intended to measure and how the intervention was to be assessed. Its statistical contribution cannot be judged from outcome definitions alone: numerical results, follow-up details, and a transparent analysis description are needed to assess event frequency, uncertainty, and any comparative inference.

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 most immediate limitation is that the registry information summarized for this trial does not report a numerical primary-endpoint result. The endpoint is defined as the count of participants with postprocedural complications within 7 days after operation, but the observed count and its classification are absent. The record therefore does not allow assessment of the frequency or precision of the primary outcome.

The study is registered as single group, with no comparator described. Any observed events would be descriptive of the treated group and could not, by themselves, establish a treatment-related difference. Although the endpoint description calls for assessment of whether complications are related to electrochemotherapy, the reported information does not include those judgments. The adverse-event figures likewise lack timing, cause, attribution, and overlap details.

The registry lists 10 as enrollment, while the study description refers to 10 patients in phase I and additional 10 patients in phase II or an extension. The record does not clarify whether the additional phase or extension took place. The phase field is NA, so the study's phase status is not resolved by the registry fields. Its recorded status is active, not recruiting, and the dates alone do not establish that all planned follow-up or analyses are complete.

Outcome definitions and follow-up details are limited. Disease-free survival and overall survival are named, but their definitions, time origin, follow-up completeness, and results are not reported in the information summarized. Missing-data handling is not reported, and the statement that all enrolled patients were included in the primary-endpoint analysis does not describe how incomplete assessments were treated. The registry lists 0 analyses and does not report a statistical analysis plan or a multiplicity procedure.

The adverse-event listing records serious events, other events, and deaths, but does not explain whether categories overlap or how events relate to the primary complication endpoint. These limitations constrain both safety interpretation and any broader inference about recurrence or survival.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Electrochemotherapy of Posterior Resection Surface for Lowering Disease Recurrence Rate in Pancreatic Cancer (PanECT Study) — NCT04281290.
• Registry record last updated 2026-03-27; status last verified 2026-03.
• Results first posted 2026-03-27.
• 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.

19. Record Summary

PanECT is a single-group study of electrochemotherapy applied to the posterior resection surface after pancreatic cancer surgery. The listed procedure uses electroporation with a Cliniporator Vitae® and Bleomycin PHC 15 e. (United States Pharmacopeia - USP). The sponsor is University Medical Centre Ljubljana. The registry records enrollment of 10, phase NA, no masking, and status active, not recruiting.

The primary endpoint is incidence of postprocedural complications for feasibility and safety, measured as a count of participants within 7 days after operation. Disease-free survival and overall survival are listed as secondary outcomes. The brief study description states an aim to evaluate toxicity and effectiveness and a longer-term intention to lower recurrence.

The registry lists 1 participant with a serious adverse event, 6 with other adverse events, and 7 deaths in the experimental group; pancreatic fistula is the top serious term at 10.0%. A numerical primary-endpoint result and numerical results for the named survival outcomes are not reported in the registry record summarized for this trial. The record lists 0 analyses.