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 Bridge to Orthotopic Liver Transplantation (OLT) - Surefire Precision vs Endhole Embolization With DEBTACE (NCT03170869), a na na study. The primary outcome is Local Recurrence Rate (LRR).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03170869 |
| Phase | NA |
| Condition | Hepatocellular Carcinoma of the Liver, Subjects Eligible for Liver Transplantation |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 11 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Colorado, Denver |
| Results posted | Yes |
2. Clinical Question
The study focused on patients with hepatocellular carcinoma who were considered candidates for liver transplantation but were outside Milan criteria and met the eligibility criteria. It was designed to evaluate DEB-TACE delivered with the Surefire Precision Infusion System, with the intention of down-staging patients to orthotopic liver transplantation. The registry record describes a prospective single-group study and a planned comparison with matched historical patients treated using standard endhole catheters. It does not report an analyzed comparison of those groups.
Population
Patients with hepatocellular carcinoma who were transplant candidates, outside Milan criteria, and met the study eligibility criteria. Details of the eligibility criteria are not reported in the registry record.
Intervention
DEB-TACE with the Surefire Precision Infusion System, intended to support down-staging to orthotopic liver transplantation.
Comparator
The planned reference was matched historical patients treated with DEB-TACE using standard endhole catheters. The registry identifies the study model as single group, so this was not a concurrent, like-for-like control group within the prospective study.
Primary question
Whether local recurrence rate at 6 months differed by catheter type. The planned test was Fisher's exact test, but zero participants were analyzed for this outcome.
This question concerns an outcome after a procedure, rather than a randomized assignment between catheter types. The record describes an intended comparison, but it does not contain primary-outcome results with which to estimate the size, direction, or precision of any difference.
3. Trial Design
The registry describes SPEED 1 as a prospective, single-group study of DEB-TACE performed with the Surefire Precision Infusion System. Its listed enrollment is 11. Allocation is recorded as NA, masking as none, and phase as NA. The study status is terminated. The start date is 2017-04-12 and the primary completion date is 2018-09-11.
The planned clinical purpose was to evaluate outcomes among patients with hepatocellular carcinoma who were candidates for liver transplantation but outside Milan criteria. The study description says the prospective cohort would be compared with matched historical control patients previously treated with DEB-TACE delivered by standard endhole catheters. Those historical patients were described as having been treated at the University of Colorado since 2009 with 100-300 micron beads and having follow-up available. The registry's single-group model means the historical reference should not be mistaken for a randomized or concurrently enrolled study arm.
The intervention was the Surefire Precision Infusion System. The record describes a 24-month study duration for each patient, with baseline and procedure visits followed by visits at 1 week, 1 month, 3 months, 6 months, and every 3 months until liver transplant or death. The available arm description is incomplete, so additional details of study procedures are not reported in the registry record.
The primary endpoint was local recurrence rate at 6 months. Secondary outcomes listed were tumor response, time to progression, and survival time. Although the record includes enrollment and safety summaries, it states that zero participants were analyzed for the primary outcome because the study was terminated before outcome data could be assessed. The reason for termination is not reported in the registry record.
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 | DEB-TACE Procedure With Surefire Precision Infusion System |
|---|---|
| STARTED | 11 |
| COMPLETED | 3 |
| NOT COMPLETED | 8 |
Reasons for not completing this period:
| Reason | DEB-TACE Procedure With Surefire Precision Infusion System |
|---|---|
| Protocol Violation | 5 |
| Early study termination | 3 |
Analysis population for the primary outcome, as defined in the registry: Zero participants analyzed as the study was terminated prior to data for outcome measures to be assessed. No data was collected or analyzed for this outcome measure.
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 | DEB-TACE Procedure With Surefire Precision Infusion System |
|---|---|---|
| Participants analysed | 11 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 9 |
| Age, Categorical: >=65 years | Participants | 2 |
| Age, Continuous | years | 60.27 (42 to 69) |
| Sex: Female, Male: Female | Participants | 2 |
| Sex: Female, Male: Male | Participants | 9 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 1 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 |
| Race (NIH/OMB): White | Participants | 10 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Region of Enrollment: United States | participants | 11 |
6. Primary Endpoint
The registry lists the primary outcome as Local Recurrence Rate (LRR), measured over 6 months.
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
Local recurrence rate (LRR) was the primary endpoint, with assessment planned at 6 months. In general, a recurrence-rate endpoint describes whether local recurrence has occurred in the population under study by a specified follow-up point. It is a categorical outcome, commonly represented as the proportion of participants with the event among those evaluated. The registry does not specify further operational details, such as how local recurrence was defined or confirmed.
The study description states that the primary analysis would test the null hypothesis of no difference in the proportion of patients with local recurrence by catheter type, using Fisher's exact test. A recurrence endpoint is relevant to a study intended to evaluate treatment outcomes because it captures a disease event at the treated site. That general rationale does not establish that the procedure changes recurrence risk, nor does it establish that recurrence was measured in this study.
The registry reports that zero participants were analyzed for LRR because the study was terminated before data for outcome measures were assessed. It also says no data was collected or analyzed for this outcome measure. Consequently, there is no observed LRR estimate, catheter-type comparison, or precision estimate to interpret from the primary endpoint. Further endpoint definitions and assessment procedures are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The central statistical fact is that the primary outcome has no analyzed participants. The registry says the study was terminated before outcome data could be assessed and reports no data collected or analyzed for local recurrence rate. Therefore, there is no observed primary-outcome result from which to estimate recurrence, compare catheter types, or assess the precision of an effect.
The record describes a planned null hypothesis of no difference in the proportion with local recurrence by catheter type and names Fisher's exact test. That is a planned analysis, not evidence that a test was carried out. The registry lists zero analyses. No primary-outcome p-value, confidence interval, effect estimate, or group-specific recurrence count is reported in the registry record. A conclusion about the direction or size of a difference would therefore go beyond the posted results.
The intended reference group was historical: patients treated with standard endhole catheters. Historical comparisons can be affected by differences between cohorts in eligibility, clinical practice, follow-up, and other factors. This is a general limitation of nonconcurrent comparisons, not evidence that any particular difference occurred in this study. The record identifies a single-group prospective model and does not provide an analyzed historical comparison. The planned comparator should not be interpreted as randomized assignment or as a concurrent control.
The enrollment figure and safety summaries do not substitute for primary endpoint data. Enrollment describes the study record, while the LRR analysis population is explicitly zero. The listed secondary outcomes—tumor response, time to progression, and survival time—also have no analyses reported. The registry does not give estimates or uncertainty intervals for them.
The safety figures are a separate part of the registry record and can be described as recorded counts and percentages. They do not establish the incidence of local recurrence or answer the catheter-type comparison. Nor do they resolve whether the intended down-staging outcome was achieved; transplant outcomes are not reported as analyzed results.
Overall, the posted information documents the study question, the planned endpoint and test, the intervention, and some safety reporting. It does not supply an efficacy result. Statistical interpretation must remain at that descriptive level: the intended comparison cannot be evaluated from the reported primary-outcome data because those data were not analyzed.
9. Statistical Methods Explained
The statistical plan described for the primary outcome is a test of whether the proportion of patients with local recurrence differed by catheter type. The registry names Fisher's exact test. No completed primary analysis is reported: the record lists zero analyses and states that zero participants were analyzed for LRR.
What does Fisher's exact test assess?
In general, Fisher's exact test evaluates association in a categorical comparison using the observed arrangement of counts. For a recurrence endpoint, the relevant categories are whether recurrence was observed or not observed, compared across catheter types. The test evaluates whether the data are compatible with the null hypothesis of no difference in proportions. A p-value, if calculated, would describe compatibility between the observed data and that null hypothesis under the test's assumptions; it would not measure the probability that the null hypothesis is true, nor quantify clinical importance by itself.
Fisher's exact test is often used for categorical data when counts may be sparse. Its exact calculation avoids relying on a large-sample approximation to the test statistic. That is a general property of the method, not a statement about the recurrence counts in SPEED 1: no such counts are reported. Without outcome observations, the test cannot produce a meaningful study result.
How should a confidence interval be read?
In general, a confidence interval describes the uncertainty around an estimated effect under a statistical procedure. For a difference in recurrence proportions, it could indicate which effect sizes remain compatible with the data, including whether the data are precise enough to distinguish a difference from little or no difference. The registry record does not report a primary-outcome estimate or confidence interval. There is therefore no interval to interpret, and no basis for describing the comparison as precise or imprecise from the endpoint data.
A non-significant test, if one had been reported, would not by itself establish equivalence or absence of an effect. Such a claim requires a suitable design and a prespecified margin or other appropriate framework. The registry does not report an equivalence margin or an analyzed result, so no equivalence conclusion is supported.
What does the historical comparison mean statistically?
The record describes a prospective cohort and a planned comparison with matched historical patients treated using standard endhole catheters. In general, matching can make groups more comparable on recorded characteristics, but it does not guarantee comparability on unmeasured factors or eliminate changes over time in care, eligibility, follow-up, or outcome assessment. Details of the matching procedure and characteristics used for matching are not reported in the registry record. The registry also identifies the study model as single group, so the historical comparison is not a randomized concurrent control.
Even if outcome data had been available, interpretation would depend on how the historical group was selected and how differences between groups were addressed. The record does not report an adjusted analysis, a matching analysis, or results for the historical cohort. The planned Fisher's exact test is described for the proportion with local recurrence by catheter type, but the exact test alone would not resolve potential confounding in a nonrandomized historical comparison.
What can the safety summaries support?
In general, adverse-event counts and proportions are descriptive unless accompanied by a prespecified comparative analysis and clear definitions of the analysis population and observation period. The registry lists a safety group and reports participants affected in serious and other adverse-event categories. It does not provide enough detail to infer event timing, duration, severity grading, causality assessment, or comparative risk. These safety summaries should not be treated as evidence for the primary endpoint.
The record's sample-size assumptions describe a planning illustration based on an observed effect, a two-sided significance level of 0.05, equal allocation, and a normal approximation; it says time-to-event illustrations give total events and other illustrations give participants per arm. These are planning concepts, not observed power. The trial's own sample-size justification is not reported in the registry record. The registry also provides no analyzed primary outcome from which to assess a study effect. Any planning illustration should not be mistaken for evidence that the study had adequate power, or for an estimate of what the study actually observed.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists one primary outcome, local recurrence rate at 6 months, and three secondary outcomes: tumor response, time to progression, and survival time. It also reports four outcome measures and zero analyses. The record does not describe a multiplicity adjustment, a hierarchy among outcomes, or a prespecified approach to interpreting multiple statistical tests. These details are not reported in the registry record.
In general, testing multiple outcomes can increase the chance of obtaining at least one apparently notable result by chance. A prespecified strategy—such as adjusting significance thresholds or defining an ordered testing plan—can address that issue. Because no outcome analyses are reported, there is no set of test results for which the presence or absence of multiplicity adjustment can be assessed. The listed outcome count alone does not establish that any testing was performed.
For the primary endpoint, the registry specifically states that zero participants were analyzed because the study was terminated before outcome data could be assessed, and that no data was collected or analyzed for that measure. This is not a report of an ordinary missing-data analysis among participants with observed outcomes. The reason outcome assessment did not occur, the amount of follow-up available, and any missing-data methods are not reported in the registry record.
The registry does not describe analysis populations, such as an intention-to-treat population or a per-protocol population, for the primary or secondary outcomes. It therefore does not establish which participants would have been included in an efficacy analysis or how deviations and incomplete follow-up would have been handled. The safety summaries have their own reported at-risk group figures, but those do not define the efficacy analysis population.
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 |
|---|---|---|---|
| DEB-TACE Procedure With Surefire Precision Infusion System | 2 | 11 | 18.2% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| DEB-TACE Procedure With Surefire Precision Infusion System | 0 of 11 |
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 |
|---|---|
| DEB-TACE Procedure With Surefire Precision Infusion System | 11 of 11 |
Most frequent serious adverse event terms
| Event term | Organ system | DEB-TACE Procedure With Surefire Precision Infusion System |
|---|---|---|
| Abdominal pain | Hepatobiliary disorders | 1 of 11 |
| Infection | General disorders | 1 of 11 |
Most frequent non-serious adverse event terms
| Event term | Organ system | DEB-TACE Procedure With Surefire Precision Infusion System |
|---|---|---|
| Abdominal pain | General disorders | 6 of 11 |
| Nausea | General disorders | 5 of 11 |
| Fatigue | General disorders | 5 of 11 |
| Abdominal distention | General disorders | 3 of 11 |
| Edema | General disorders | 3 of 11 |
| Elevated lactate whole blood venous levels | General disorders | 3 of 11 |
| Elevated AFP levels | General disorders | 2 of 11 |
| Occasional hot flashes | General disorders | 2 of 11 |
| Mild groin paint post re-treatment | General disorders | 2 of 11 |
| Muscle wasting | General disorders | 2 of 11 |
Serious events with the highest arm-level rate: abdominal pain (9.1%), infection (9.1%).
The registry lists one safety group, titled DEB-TACE Procedure With Surefire Precision Infusion System. It reports 11 participants at risk for serious adverse events and 2 affected, alongside 11 at risk for other adverse events and 11 affected. Deaths are recorded as 0. The most frequent serious adverse-event terms listed are abdominal pain and infection, each at 9.1%.
These entries should be read as the registry's safety summaries, not as a comparative estimate between catheter types. The record does not provide a concurrent control group in the prospective study, and no comparative safety analysis is listed. The displayed percentages do not establish cause, severity beyond the serious-event classification, duration, or whether an event was judged related to the procedure or device.
Definitions of serious and other adverse events, the observation period for these summaries, and the rules for attributing events are not reported in the registry record. The term list should not be treated as a complete narrative of the clinical course, and the two listed serious-event terms should not be added to infer a total number of events. The affected counts are participant-level summaries in the registry, not a substitute for the missing primary endpoint analysis.
12. What the Result Does, and Does Not, Mean
The registry record documents a study designed to evaluate DEB-TACE using the Surefire Precision Infusion System in patients with hepatocellular carcinoma who were transplant candidates but outside Milan criteria. It identifies local recurrence rate at 6 months as the primary outcome and Fisher's exact test as the planned method for comparing proportions by catheter type. It also records an intended reference to matched historical patients treated with standard endhole catheters.
The key result is that no primary-outcome result is available: zero participants were analyzed for LRR, and the registry says no data was collected or analyzed for that measure before the study was terminated. Thus, the record does not show whether local recurrence was more or less common with either catheter approach. It does not support an estimate of effect, a claim of statistical significance, or a claim that the approaches were equivalent.
The study's single-group model and historical comparison also matter. The record does not report an analyzed historical cohort comparison, matching details, or adjustments for differences between cohorts. Even a reported association in such a comparison would require cautious interpretation because nonrandomized historical groups can differ in ways that affect outcomes. Here, the absence of primary-outcome data means that even a descriptive comparison cannot be made.
The adverse-event figures are separate safety descriptions. They do not answer the recurrence question or establish the intended down-staging outcome. Secondary outcomes are listed, but analyses for them are not reported. A registry record can document a planned study question and limited collected information without providing evidence that resolves that question.
Accordingly, the most defensible interpretation is descriptive: the study was intended to assess a clinically relevant outcome, but its posted record contains no analyzed efficacy result. The reason for termination and further details about the study's conduct are not reported in the registry record.
13. Why This Trial Matters Statistically
This trial illustrates the distinction between a defined research question and an answer supported by analyzed data. SPEED 1 names a specific clinical population, intervention, primary endpoint, and planned statistical test. Yet the registry reports zero participants analyzed for local recurrence rate because the study was terminated before outcome assessment. A clearly stated endpoint does not itself create an estimate or permit a treatment comparison.
The record also illustrates why study design and comparator structure matter. The prospective component is identified as single group, while the intended reference consists of matched historical patients treated with standard endhole catheters. Historical information can provide context, but it is not equivalent to concurrent randomized evidence. The matching approach and any analysis of between-group differences are not reported in the registry record.
It also demonstrates the importance of separating outcome domains. Safety summaries are present, but they do not answer the primary efficacy question. The listed secondary outcomes likewise do not provide results simply by being named. A reader needs outcome definitions, analysis populations, effect estimates, and uncertainty to evaluate evidence; those primary-outcome results are absent.
For statistical interpretation, this record is a useful example of restraint: no p-value or effect estimate should be inferred from a planned test, and enrollment or safety counts should not be repurposed as efficacy evidence. The registry makes the absence of primary endpoint analysis explicit, which sets a clear limit on what the study can establish from the posted information.
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 most direct limitation is that no primary outcome data were analyzed. The registry states that zero participants were analyzed for local recurrence rate because the study was terminated before outcome measures could be assessed. This prevents estimation of the primary endpoint and comparison by catheter type.
The record identifies the study as single group, although its description refers to a planned comparison with matched historical controls. It does not report an analyzed historical comparison, the matching variables, how historical patients were selected, or how potential differences between cohorts were handled. The comparator therefore cannot be treated as a concurrent or randomized control.
The registry does not report the reason for termination, a sample-size justification for the trial's own design, interim analyses, or a detailed statistical analysis plan. The sample-size assumptions describe a planning illustration, but the record does not provide an efficacy result from which to assess power or precision. Definitions and assessment procedures for the primary endpoint are also not reported in the registry record.
Although secondary outcomes are listed, no analyses are reported for them. The record does not explain the analysis populations or any missing-data procedures. Safety information is limited to the recorded summary counts and listed serious-event terms; event timing, attribution, and observation-window details are not reported. These limitations restrict both efficacy interpretation and the context available for understanding safety.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Bridge to Orthotopic Liver Transplantation (OLT) - Surefire Precision vs Endhole Embolization With DEBTACE — NCT03170869.
- Registry record last updated 2022-01-12; status last verified 2021-12.
- Results first posted 2022-01-12.
- 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
SPEED 1 was a prospective, single-group study of DEB-TACE using the Surefire Precision Infusion System for patients with hepatocellular carcinoma who were transplant candidates but outside Milan criteria. The registry lists enrollment of 11 and records the study as terminated.
The primary endpoint was local recurrence rate at 6 months, with Fisher's exact test planned for a comparison by catheter type. The study description refers to matched historical patients treated with standard endhole catheters, but no analyzed comparison is reported. The registry states that zero participants were analyzed for the primary outcome because the study was terminated before outcome data could be assessed.
Secondary outcomes listed were tumor response, time to progression, and survival time. The registry reports zero analyses. Safety summaries are recorded separately, including 2 participants affected in the serious adverse-event category and 0 deaths. The reason for termination and further analysis details are not reported in the registry record.