A Comparison of Eleview Versus Hetastarch as Injectate for EMR: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Comparison of Eleview Versus Hetastarch as Injectate for EMR (NCT03350217), a randomized phase 4 study. The primary outcome is Sydney Resection Quotient (SRQ).

2. Clinical Question

3. Trial Design

This was a randomized, parallel-group comparison of Eleview and Hetastarch during EMR of colonic lesions equal to or larger than 11 millimeters. The record lists the trial as Phase 4, with enrollment of 160, and status as completed. The start date was 2017-10-09, and the primary completion date was 2019-01-07.

The official title describes the study as randomized, comparative, and double-blind. In contrast, the structured masking entry says single. The identity of the masked party or parties is not reported in the registry record, so the difference between those descriptions cannot be resolved from the record alone. The randomization method, allocation concealment procedures, and any stratification are not reported in the registry record.

Participants were assigned to receive one of the two injectates. The Eleview arm description specifies administration after randomization and a maximum of 50 mL's. The Hetastarch arm description specifies methylene blue as a contrast agent. The registry describes injection-assisted EMR as using an injectate to create a submucosal lift before removal; this provides context for the procedure, not a reported comparison result.

The primary outcome was SRQ during large polyp removal. Named secondary outcomes concern injection volume, re-injections, resection pattern, and the dimensions and duration of the submucosal mound. Although the record lists 13 outcome measures, the complete analysis specifications and results are not reported in the registry record. The record contains no analyses. It also does not report the sample-size justification, the planned statistical analysis, interim analyses, or the specific analysis populations.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Overall Study

Analysis population for the primary outcome, as defined in the registry: Some patients had more than one eligible polyp for the study so there ended up being 84 adenomas and 30 serrated lesions in the Eleview arm and 75 adenomas and 27 serrated lesions in the Hetastarch arm. The number of patients within a column doesn't equal the number of overall patients in the arm because some had both types of polyps.

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 Sydney Resection Quotient (SRQ), measured over During the large polyp removal.

The primary endpoint is the Sydney Resection Quotient (SRQ), recorded as a mean with standard deviation and a ratio unit. The registry defines SRQ as polyp size divided by the number of pieces in which that polyp was resected. It states that a larger SRQ is better than a smaller SRQ. The measurement timeframe is during large polyp removal.

In general, this kind of measure combines lesion size and the number of resected pieces into a single summary. The number of pieces matters to the endpoint because it is part of the stated quotient definition. The registry does not provide additional details about how polyp size was measured, the unit used for that size, or how SRQ was handled when a patient contributed more than one eligible polyp.

The record names the endpoint and its summary type but does not report the arm-specific mean SRQs, standard deviations, or a between-arm estimate. Without those values, it is not possible to describe the observed difference, its variability, or its precision. Nor does the registry record report a confidence interval or a statistical test for the primary comparison.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

SRQ is a continuous outcome summarized in the record by a mean and standard deviation. The mean describes the central value of observations, while the standard deviation describes how spread out those observations are around the mean. These summaries would help characterize each arm, but the registry record does not report the arm-specific mean or standard deviation. The endpoint is defined as polyp size divided by the number of pieces in which the polyp was resected, and the record states that a larger value is better.

What would a between-arm estimate show?

In general, a between-arm estimate expresses the observed contrast in the outcome between the randomized groups. Interpreting it requires knowing the values being compared and how the analysis was carried out. Here, the registry record does not report a primary comparison estimate, its direction, or its uncertainty. It therefore does not support a numerical interpretation of the difference between Eleview and Hetastarch.

How should uncertainty be read?

In general, a confidence interval communicates the precision of an estimate by giving a range of values compatible with the data and the method used. A narrow interval indicates greater precision than a wide interval, while an interval that includes values on both sides of no difference can leave the direction uncertain. No confidence interval is reported for SRQ. No test statistic or p-value for the primary comparison is reported either. A p-value alone would not describe the size of an effect or its clinical relevance; it is interpreted alongside the estimate and its uncertainty.

Why do repeated lesions matter?

The registry reports lesion counts and notes that some patients had more than one eligible polyp. This creates a distinction between the unit of randomization and the unit of outcome measurement that a statistical analysis may need to address. In general, outcomes from multiple lesions in one participant may be correlated rather than independent. If so, methods that account for within-participant clustering can affect standard errors and confidence intervals. The registry record does not report whether analyses were conducted at the lesion or participant level, or how dependence among multiple lesions was handled.

What can the design description establish?

The record identifies a randomized, parallel-group design. Randomization is generally intended to make assigned groups comparable with respect to both measured and unmeasured characteristics, on average. That rationale does not substitute for information about the randomization sequence, concealment, departures from assignment, or analysis. Those details are not reported in the registry record. The official title calls the trial double-blind, whereas the structured masking entry says single; the masked party or parties are not specified.

The structured outcome summary says the endpoint is a mean and standard deviation, but that alone does not identify the inferential method. The record does not specify whether an unadjusted or adjusted comparison was planned, what model or test was used, how the analysis handled skew or outliers, or whether assumptions were checked. These details are not reported in the registry record. No statistical method should be inferred from the endpoint summary alone.

What does the planning illustration represent?

In general, sample-size planning asks how many participants may be needed to detect a specified effect under assumptions about the significance level, allocation, and statistical model. A planning illustration based on an observed effect is not the trial's original design justification and is not observed power. The record's planning assumptions describe a two-sided significance level of 0.05, equal allocation, a normal approximation, and an effect defined as a stated fraction of the observed effect. The trial's own sample-size justification is not reported in the registry record. Because no primary effect estimate is posted, the record does not provide the observed result needed to interpret a planning calculation as a trial-specific effect.

In general, over-dispersion means that outcome variability is greater than a model assumes. When present, a model that ignores it can understate uncertainty. This is a general statistical consideration, not a reported feature of this trial. The registry record does not report whether over-dispersion was assessed or whether a method addressing it was used.

Finally, the presence of a randomized design and a named primary outcome does not establish that the analysis was prespecified or complete. The analysis plan, handling of missing outcomes, interim analyses, and the populations included in analyses are not reported in the registry record. With no analyses listed, the methods used to generate a primary result cannot be evaluated from the posted record.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists the SRQ as the primary outcome and names secondary outcomes relating to injected volume, re-injections, resection pattern, and mound concentration and duration. It also states that there are 13 outcome measures. The record does not report a multiplicity plan, such as whether secondary comparisons were treated as exploratory or whether any adjustment was planned for testing multiple outcomes. Without that information and without analysis results, the chance of false-positive findings across multiple tests cannot be evaluated.

The record does not report whether the primary outcome had multiple categories or time points in the analysis. It also does not report a strategy for missing outcome measurements, exclusions, protocol deviations, or analysis populations. The number of people with missing outcomes and the reasons for missingness are not reported in the registry record. These omissions prevent assessment of whether the reported population, if results were available elsewhere, would represent all randomized participants or a selected subset.

In general, missing data can affect both the estimate and its uncertainty, and the consequences depend on why values are missing and how they are handled. A complete-case analysis, an imputation method, and other approaches rely on different assumptions. No missing-data method is reported in the registry record, so none should be presumed. The record also does not report whether an intention-to-treat analysis was planned or whether participants were analyzed according to assignment.

The enrollment entry is 160, but this does not identify the denominator for every outcome. Some participants contributed more than one eligible lesion, and the registry provides lesion counts separately from overall patients per arm. The relationship between those records and the analysis population is not reported. The trial's sample-size rationale, multiplicity handling, and analysis populations are not reported in the registry record.

11. 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 non-serious adverse event terms

The safety fields list serious adverse events for 77 people at risk in the Eleview group and 81 people at risk in the Hetastarch group. The number affected by serious adverse events is 0 in each group. Deaths are also listed as 0 in each group. For other adverse events, the record lists 16 affected among 77 at risk in the Eleview group and 15 affected among 81 at risk in the Hetastarch group.

These are counts from the registry's adverse-event fields. The record does not give event names, severity categories for the other events, timing, duration, or an analysis comparing groups. It does not explain the definitions used to classify serious and other adverse events, or whether one person could contribute more than one event. The counts therefore should not be read as a complete description of the safety experience or as a statistical comparison between groups. Zero reported serious events and zero deaths in these fields do not establish that no other safety outcomes occurred.

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

The record documents a randomized comparison of two injectates used during EMR and identifies SRQ as the primary outcome. It also supplies selected safety counts and describes several secondary outcomes. These details clarify what the trial set out to compare and the kinds of measurements it considered.

The registry record does not report the primary outcome results or any analyses. Therefore, it does not show the arm-specific SRQ values, the estimated difference, or the uncertainty around a comparison. It cannot establish from the posted results whether one group had a higher SRQ, whether any difference was precise, or whether the data were compatible with a range of possible differences. No conclusion about the primary comparison should be inferred from the study title, outcome definition, or proposed direction that a larger SRQ is better.

The record also does not report results for the named secondary outcomes. The adverse-event counts offer limited descriptive information, but not event-level detail or a comparative analysis. Counts of affected people in these registry fields do not, by themselves, describe the nature or timing of events, and they should not be treated as a full benefit-risk assessment.

More broadly, a trial's design describes how a comparison was intended to be made; the result and its precision depend on the observed data and the analysis. Those results are absent from this registry record. The listed enrollment of 160 does not reveal how many participants or lesions contributed to each outcome analysis, especially because some participants had multiple eligible polyps. Analysis populations, missing-data handling, and methods for accounting for multiple lesions are not reported.

Accordingly, the record supports a description of the research question, design, endpoint definition, and selected adverse-event counts. It does not support a conclusion about the comparative SRQ outcome or a broader conclusion about the relative performance of the two injectates.

13. Why This Trial Matters Statistically

This trial raises statistical questions that are common in procedural studies. A randomized comparison can be informative, but interpretation depends on reporting both the estimated contrast and its uncertainty. Naming a primary endpoint is not enough: readers also need the arm-level results, analysis method, and a measure of precision. Those primary results are not reported in the registry record.

The unit of observation is also important. The registry notes that some participants had more than one eligible polyp and reports lesion counts by arm. If more than one lesion from a participant contributes to an analysis, observations may be related. In general, treating related observations as independent can make uncertainty estimates too optimistic. The registry record does not report how this issue was handled.

Multiplicity is another general consideration. The record names multiple secondary outcomes and lists 13 outcome measures, but does not describe a plan for interpreting multiple comparisons. When many outcomes are examined, the chance of observing an apparently notable result by chance can increase; the degree of concern depends on the analysis plan and reporting. No such plan or analysis results are available in the registry record.

Finally, the difference between the official title's double-blind description and the structured single-masking entry illustrates why design details should be reported consistently. The record does not say which parties were masked. Clear information about masking, outcome assessment, missing data, and analysis populations would help readers judge the reliability and precision of a reported result. In this record, those details and the primary outcome analysis are absent, so the statistical significance of the study lies in the questions it raises about transparent reporting rather than an assessable treatment comparison.

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 main limitation for interpreting this trial from the registry record is the absence of posted analysis results. Although SRQ is identified as the primary outcome and its definition is given, the arm-specific means, standard deviations, comparison estimate, and uncertainty are not reported. The record lists zero analyses, so the primary comparison cannot be evaluated statistically.

The record gives no complete statistical analysis plan. The method for comparing groups, treatment of multiple lesions within a participant, handling of missing outcomes, and analysis populations are not reported in the registry record. Some patients had more than one eligible polyp, so lesion counts cannot be interpreted as patient counts. The record does not explain how this distinction was reflected in the analysis.

Masking is described inconsistently: the official title says double-blind, while the structured masking field says single. The masked party or parties and the procedures used to maintain masking are not reported. The randomization method and allocation concealment are also not reported.

The registry lists 13 outcome measures but does not provide a multiplicity plan or results for the named secondary outcomes. The sample-size justification is not reported. The posted adverse-event fields include counts, but not event-specific descriptions, definitions, timing, or comparative analyses. These limitations mean that the registry record supports a description of the trial's design and selected safety counts, but not an assessment of the primary endpoint result, its precision, or the completeness of the safety account.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: A Comparison of Eleview Versus Hetastarch as Injectate for EMR — NCT03350217.
• Registry record last updated 2019-12-17; status last verified 2019-12.
• Results first posted 2019-12-17.
• 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.

18. Record Summary

NCT03350217 is a completed Phase 4 randomized, parallel-group comparison of Eleview and Hetastarch as injectates for EMR of colonic lesions equal to or larger than 11 millimeters. The registry lists enrollment of 160 and identifies SRQ as the primary outcome, defined as polyp size divided by the number of resection pieces. Some participants had multiple eligible polyps.

The official title describes the study as double-blind, while the structured masking entry says single; the masked party or parties are not reported. The record lists zero analyses and does not report primary or secondary outcome results. It reports zero serious adverse events and zero deaths in both groups, alongside other adverse events affecting 16 people in the Eleview group and 15 in the Hetastarch group. Analysis methods, missing-data handling, and the trial's sample-size justification are not reported in the registry record.