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 Bronchoscopic Laser Ablation of Peripheral Lung Tumors (NCT03707925), a na na study. The primary outcome is Pathologic Changes From Bronchoscopic Laser Ablation of Peripheral Lung Tumors.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03707925 |
| Phase | NA |
| Condition | Lung Carcinoid Tumor, Lung Non-Small Cell Carcinoma, Metastatic Lung Carcinoma |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 4 |
| Arms in the primary outcome | n/a |
| Lead sponsor | M.D. Anderson Cancer Center |
| Results posted | Yes |
2. Clinical Question
Population
The study concerns patients with peripheral lung tumors who underwent bronchoscopic tumor ablation. The registry lists lung carcinoid tumor, lung non-small cell carcinoma, metastatic lung carcinoma, and advanced lung cancer conditions. The primary-outcome description specifies that only patients who underwent bronchoscopic tumor ablation are included in its analysis. The record does not report further eligibility details or the characteristics of the analyzed participants.
Intervention
The procedure is bronchoscopic laser ablation, performed after standard bronchoscopy and endobronchial ultrasound. A catheter is guided into the tumor, and a laser probe is passed through it to apply heat. Cone-beam computed tomography is performed before and after ablation. These procedural details describe the study approach; they do not establish how much tumor change occurred.
Comparator
There is no separate control group in this single-group study. The registry lists allocation as not applicable and masking as none. Participants undergo surgical resection after ablation, but that resection is part of the study sequence and is used to obtain tissue for pathological assessment, not as a randomized comparison group.
Primary question
The primary question is whether examination of the resected tumor shows pathological changes categorized as complete, quasi-complete, or incomplete ablation. The registry describes staining-based criteria for these categories and an assessment timeframe of up to 16 months. Outcome-analysis results are not reported in the registry record, so the record does not establish the distribution of these categories or the degree of tumor change observed.
3. Trial Design
This is a single-group interventional study listed as terminated. The registry reports an enrollment of 4 and no masking. Allocation is listed as not applicable, consistent with the absence of a randomized comparison group. The study is sponsored by M.D. Anderson Cancer Center. Its phase is listed as not applicable.
The study procedure combines bronchoscopic laser ablation with subsequent surgical resection. Participants undergo bronchoscopy and endobronchial ultrasound, with cone-beam computed tomography before and after the laser procedure. A catheter is passed into the lung tumor under imaging guidance, and a laser probe is used to apply heat. The registry describes standard surgical resection of the lung tumor 48-72 hours after the ablation procedure. The resected specimen is then examined to characterize pathological changes.
This sequence is important to the design: surgery supplies tissue for assessment after ablation, but it does not create a control arm. The study therefore can describe findings in treated tumors, but its design does not support a randomized between-group estimate of the effect of ablation. There is no like-for-like comparison group in the registry record.
The registry gives a start date of 2018-09-18 and a primary completion date of 2022-01-20. It lists the study status as terminated, but the reason for termination is not reported in the registry record. The record does not report why enrollment was 4, whether that number reflects the intended target, or whether recruitment ended earlier than planned. Phase, allocation, and masking entries should be read as registry design information, not as evidence about the outcome.
The primary endpoint is a participant count across pathological categories, with a stated timeframe of up to 16 months. The registry describes extensive descriptive analyses and 90% confidence intervals for measures of interest. It does not report outcome analyses for that endpoint.
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.
Before assignment: 4 participants consented, 1 inevaluable
Overall Study
| Stage | Bronchoscopic Laser Ablation, Cone-beam CT(CBCT) |
|---|---|
| STARTED | 4 |
| COMPLETED | 3 |
| NOT COMPLETED | 1 |
Reasons for not completing this period:
| Reason | Bronchoscopic Laser Ablation, Cone-beam CT(CBCT) |
|---|---|
| Inevaluable | 1 |
Analysis population for the primary outcome, as defined in the registry: Only patients who underwent bronchoscopic tumor ablation are included in the 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.
| Characteristic | Unit | Bronchoscopic Laser Ablation, Cone-beam CT(CBCT) |
|---|---|---|
| Participants analysed | 4 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 2 |
| Age, Categorical: >=65 years | Participants | 2 |
| Sex: Female, Male: Female | Participants | 3 |
| Sex: Female, Male: Male | Participants | 1 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 4 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 1 |
| Race (NIH/OMB): White | Participants | 3 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Region of Enrollment: United States | participants | 4 |
6. Primary Endpoint
The registry lists the primary outcome as Pathologic Changes From Bronchoscopic Laser Ablation of Peripheral Lung Tumors, measured over Up to 16 months.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint concerns pathological changes in tumor tissue after bronchoscopic laser ablation. Resected specimens are assessed using staining with anti-mitochondria antibody MAB 1273 or nicotinamide adenine dinucleotide-hydrogen, or both. The registry defines complete ablation as absence of staining in tumor cells, quasi-complete ablation as positive staining of 10% of tumor cells, and incomplete ablation as positive staining in > 10% of tumor cells.
This endpoint uses tissue examination to characterize what is present in the tumor after the procedure. It is distinct from a symptom, imaging, or long-term survival outcome: the stated measure is a count of participants classified by pathological change. The categories provide a descriptive way to report the extent of staining in the resected specimen under the registry's definitions.
Pathological assessment is relevant to this study because the protocol includes surgical removal of the tumor after ablation, making tissue available for examination. However, the registry record does not report the category counts, the detailed assessment procedures, or the outcome analyses. The endpoint definition alone therefore indicates what was intended to be measured, not what the study found.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes a small, single-group study with enrollment of 4. Its stated primary outcome is a count of participants classified by pathological change after bronchoscopic laser ablation and surgical resection. The record reports the endpoint definition and the plan for descriptive analyses with 90% confidence intervals, but it does not report outcome-analysis results. The proportions in the pathological categories, their uncertainty, and any estimate of observed tumor change are therefore not reported in the registry record.
Without reported outcome counts, there is no basis in the registry record for describing how often complete, quasi-complete, or incomplete ablation was observed. The absence of a reported analysis is not evidence that no pathological change occurred, nor does it indicate that all participants had the same finding. It means the record does not provide the results needed to characterize the endpoint.
The single-group design also sets a limit on interpretation. Because there is no separate control group, the study cannot provide a randomized comparison of ablation against another procedure or no ablation. The surgical resection follows ablation and supplies the specimen used for assessment; it is not a control condition. Any pathological findings, if reported, would describe the treated group and would not by themselves establish what would have happened without ablation.
Confidence intervals are planned in the endpoint description, but no endpoint estimates or interval limits are reported in the registry record. In general, a confidence interval communicates uncertainty around an estimate; with limited information, it cannot be used to establish the precision of an unreported result. No inference about statistical significance can be made from the endpoint description alone.
The registry lists enrollment of 4 and a terminated status. It does not report the reason for termination or whether the recorded enrollment matches the intended target. The status does not, on its own, explain why the study stopped or establish anything about the pathological outcome. The posted record should therefore be read as a description of the study design and its intended measurement, not as a complete presentation of the study's primary results.
For the same reason, no conclusion about the reproducibility of the procedure, the frequency of any particular pathological category, or comparative performance is supported by the reported endpoint information. Those questions would require outcome details that are not reported in the registry record.
9. Statistical Methods Explained
What does a participant count represent?
The primary measure is a count of participants assigned to categories based on staining in the resected tumor. A count describes how many participants meet a stated definition; it is not a continuous measurement of tumor size or a time-to-event measure. The registry gives definitions for complete, quasi-complete, and incomplete ablation, based on whether staining is absent or present and on the specified proportion of tumor cells with positive staining.
Those definitions are operational rules for classifying pathological findings. A category depends on applying the stated staining criteria to the tissue specimen. The registry record does not provide further detail on pathology review, whether assessors were blinded, how disagreement was handled, or how missing or inadequate specimens would be treated.
Why describe categories rather than compare averages?
For an endpoint defined as participant counts in named categories, descriptive analysis can report the observed distribution without imposing a model for a continuous outcome. The registry says it will conduct extensive descriptive analyses and calculate appropriate summary statistics and 90% confidence intervals. It does not report the resulting category counts, summary statistics, or confidence intervals.
In general, descriptive statistics organize the observed data, while inferential statistics use a model or sampling framework to quantify uncertainty or make comparisons. A confidence interval is an interval estimate intended to express uncertainty around a statistic under specified assumptions. It is not a guarantee that the true value lies within the interval, and its interpretation depends on the analysis method and data. Here, the registry specifies an intended confidence level but does not report estimates or interval limits for the primary outcome.
What does the single-group design allow?
The study has one group receiving bronchoscopic laser ablation followed by resection. In general, a single-group study can describe observed outcomes in participants who receive an intervention. Without a separate comparator group, it cannot estimate a treatment contrast against a control condition. The sequence of ablation and later surgery does not form a control comparison because the surgery is part of the study procedure and the resected specimen supports endpoint assessment.
This distinction matters even if a pathological finding is measured consistently. A post-procedure observation describes the tissue assessed after the procedure; by itself, it does not show what the same tumor would have looked like under an alternative approach. The registry does not report a randomized or otherwise like-for-like control comparison.
How should planning calculations be understood?
General sample-size calculations are planning tools: they describe the number of participants that a hypothetical study might need under stated assumptions. The assumptions listed for planning illustrations are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect expressed as a stated fraction of the observed effect. These are calculation assumptions, not a description of this trial's design. This study is single-group and has no two-arm allocation in the registry record.
Any such sample-size figure is a planning illustration, not observed power and not evidence that the study was designed around that calculation. The registry record does not report the trial's own sample-size justification or statistical plan. A planning calculation cannot substitute for the missing primary-outcome results, and it does not demonstrate that an effect was observed.
Why does over-dispersion matter in general?
Over-dispersion is a general issue for count data when the variation in observations is greater than a chosen statistical model expects. If it is ignored, uncertainty estimates from that model can be too narrow. Whether over-dispersion is relevant depends on the outcome structure and analysis method. The registry record does not report an analysis model for the primary endpoint, so it does not establish that over-dispersion was assessed or that a particular model was used.
For this endpoint, the stated analysis is descriptive, with summary statistics and confidence intervals. The record does not provide enough detail to identify the specific interval method, assumptions, or any adjustment used. It would not be appropriate to infer those choices from the general statement that confidence intervals were planned.
What can be concluded from the posted analysis information?
The registry reports one primary outcome measure and describes a planned descriptive approach, but outcome-analysis results are not reported in the registry record. Thus there are no posted primary endpoint estimates from which to assess category frequencies or precision. The registry also does not report the statistical plan in enough detail to establish whether any additional analyses were prespecified, how deviations were handled, or how analysis decisions were made.
10. Multiplicity, Missing Data and Analysis Populations
The registry identifies one primary outcome measure and says that extensive descriptive analyses and 90% confidence intervals will be calculated. It does not report a multiplicity adjustment or explain how multiple summaries, categories, or other measures would be handled. A formal adjustment for multiplicity is therefore not reported in the registry record. Because the endpoint results are also not reported, the record does not show whether multiple statistical tests were performed.
The primary-outcome population is described as only patients who underwent bronchoscopic tumor ablation. The record does not give further definitions of analysis populations, such as a separate intention-to-treat set, a per-protocol set, or rules for including participants with incomplete procedures. It also does not report missing-data counts, the handling of missing pathological assessments, imputation methods, or sensitivity analyses for missing data.
In general, missing-data methods matter because an analysis based only on observed outcomes can be affected if availability of an outcome is related to the outcome itself or to participant characteristics. Imputation and sensitivity analyses can address different assumptions, but no such methods should be presumed when they are not described. The registry record does not report which assumptions, if any, were used.
The posted record reports enrollment of 4, but does not provide participant-level flow from enrollment through procedure, resection, pathology assessment, and inclusion in the primary analysis. Consequently, the number contributing to the endpoint analysis and the reasons for any exclusions or missing observations are not reported in the registry record.
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 |
|---|---|---|---|
| Bronchoscopic Laser Ablation, Cone-beam CT(CBCT) | 1 | 4 | 25.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Bronchoscopic Laser Ablation, Cone-beam CT(CBCT) | 0 of 4 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Bronchoscopic Laser Ablation, Cone-beam CT(CBCT) | 0 of 4 |
Most frequent serious adverse event terms
| Event term | Organ system | Bronchoscopic Laser Ablation, Cone-beam CT(CBCT) |
|---|---|---|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | 1 of 4 |
Serious events with the highest arm-level rate: pneumothorax (25.0%).
The registry lists a serious adverse event count of 1 among 4 at risk in the bronchoscopic laser ablation, cone-beam CT group. It lists 0 other adverse events and deaths of 0. Pneumothorax appears among the top serious terms at 25.0%. These entries describe the safety figures recorded for the study; they do not provide a comparison with another group.
These counts are based on a small enrolled group, so they should be read as descriptive observations rather than precise estimates of event frequency. The registry record does not provide further detail about event timing, severity grading, relatedness to the procedure, duration, management, or the criteria used to classify events as serious. It also does not report whether all participants had the same duration of safety follow-up.
A listed serious event does not by itself establish that the procedure caused the event. Attribution requires information about the event and the assessment process, which is not reported in the registry record. Similarly, the absence of recorded deaths or other adverse events in this entry does not establish that no additional safety events occurred outside the recorded data. The available figures should be interpreted only as the posted registry counts and term listing.
12. What the Result Does, and Does Not, Mean
The registry record establishes that the study evaluated bronchoscopic laser ablation of peripheral lung tumors followed by surgical resection, with pathological assessment of the resected tissue as the primary outcome. It also describes the staining-based definitions for complete, quasi-complete, and incomplete ablation and states that descriptive analyses and 90% confidence intervals were planned.
What the registry record does not establish is the observed distribution of pathological outcomes. The endpoint analysis is not reported, so no result can be stated for the frequency of any category, the extent of staining, or the precision of an estimate. The endpoint definitions are not outcome findings. Likewise, the record's enrollment and terminated status do not reveal why the study ended or what the pathological results were.
Even if the endpoint results were available, the single-group design would support description of observations in the treated group rather than a randomized comparison with another treatment. The subsequent surgery provides tissue for assessment, but is not a control arm. The registry therefore does not provide a controlled estimate of how outcomes differ from what would occur under an alternative procedure or without ablation.
The safety entries report 1 serious adverse event among 4 at risk, 0 other adverse events, and 0 deaths, with pneumothorax listed at 25.0% among the top serious terms. These are descriptive registry entries. The record does not give the clinical details or event attribution needed to interpret cause, and it does not support a comparative safety assessment.
In general, statistical interpretation depends on both the design and the results reported. A defined endpoint and a planned confidence-interval approach do not replace observed estimates. The registry record is informative about the study question and procedure, but the missing outcome analyses prevent conclusions about the primary pathological endpoint.
13. Why This Trial Matters Statistically
This study illustrates the difference between defining a measurable clinical question and reporting its answer. The registry specifies a tissue-based endpoint with staining criteria and a descriptive analysis plan. Such definitions matter because clear operational criteria make it possible to understand what a reported category is intended to represent. Without the category counts and analysis results, however, the endpoint remains a measurement plan rather than an interpretable result.
The design also highlights why the comparator matters. Bronchoscopic ablation is followed by surgery, which enables examination of the treated tumor. That sequence has a clear role in endpoint measurement, but it does not create a control group. A single-group study can contribute descriptive information, while questions about comparative effects require a suitable comparison and a design that supports that contrast.
Small enrollment makes transparent reporting of participant flow and uncertainty especially important. The registry reports enrollment of 4, but does not report how many contributed to the primary endpoint analysis or provide outcome estimates and confidence intervals. Readers therefore cannot assess the precision of the planned pathological summaries from the registry record.
The record also shows the limits of registry status information. A terminated status is reported, but the reason is not. Without that context or the endpoint results, readers should not infer either the reason for termination or the study's findings. Statistically, the key lesson is that design details, endpoint definitions, analysis plans, and observed results are distinct pieces of evidence; the record reports some of these, but not the primary outcome analyses.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The primary limitation for interpreting this study is that outcome-analysis results are not reported in the registry record. Although the endpoint and planned descriptive summaries are described, the pathological category counts, estimates, and confidence intervals are absent. This prevents assessment of the primary outcome and its precision.
Enrollment is reported as 4, and the study is listed as terminated. The reason for termination and whether the recorded enrollment was the intended target are not reported in the registry record. Participant flow from enrollment through ablation, resection, pathology assessment, and endpoint analysis is also not reported. This leaves the endpoint denominator and any exclusions unclear.
The single-group design has no like-for-like control comparison. As a result, the design does not provide a randomized between-group estimate. The record also does not report details on pathology assessor blinding, review procedures, missing specimens, or rules for resolving uncertain classification. Those omissions limit appraisal of how consistently the primary outcome was assessed.
The registry describes confidence intervals but not the specific calculation method, model assumptions, or multiplicity procedures. It does not report a statistical plan or the trial's own sample-size justification. The safety information is also limited: event timing, relatedness, and other clinical details are not reported in the registry record. These are limits on interpretation of the recorded information, not evidence that particular procedures or analyses did or did not occur.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Bronchoscopic Laser Ablation of Peripheral Lung Tumors — NCT03707925.
- Registry record last updated 2023-02-16; status last verified 2023-01.
- Results first posted 2023-02-16.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
The registry describes a single-group study of bronchoscopic laser ablation for peripheral lung tumors, followed by surgical resection. Cone-beam computed tomography is performed before and after ablation, and the resected specimen is assessed for pathological changes. The primary endpoint counts participants classified by staining-based categories, with a timeframe of up to 16 months.
The record lists enrollment of 4, no masking, and terminated status. It describes planned descriptive analyses and 90% confidence intervals, but outcome-analysis results are not reported in the registry record. The reason for termination, participant flow, and details of missing-data handling are also not reported.
The safety entry lists 1 serious adverse event among 4 at risk, 0 other adverse events, and 0 deaths; pneumothorax is listed at 25.0% among the top serious terms. Because the study has no separate control group, it does not provide a randomized comparison.