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 Feasibility Study on the Contribution of Guided Puncture With Echoendoscopy (NCT01892501), a na na study. The primary outcome is Sensitivity of Endoscopic Ultrasound-guided (EUS-guided) Puncture.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01892501 |
| Phase | NA |
| Condition | Hypermetabolic Lymphadenopathy Mediastinum Lower, Posterior and Middle, Detected by PET-CT With 18F-FDG (PET) |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 75 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Institut Bergonié |
| Results posted | Yes |
2. Clinical Question
Population
Patients with hypermetabolic mediastinal lymph nodes detected by PET, in the context of new cancer or cancer recurrence. The primary-endpoint population is described as 47 eligible and evaluable patients; exclusions included non-contributory histology, puncture not carried out, or radiological monitoring not carried out.
Intervention
Guided puncture of mediastinal lymphadenopathy by echoendoscopy, also described as EUS-guided puncture. The procedure was performed after PET detected lymph nodes. The registry also lists a PET scan as an intervention device.
Comparator
PET is identified as the reference technique, with assessment over 12 months. This is a diagnostic reference, not a randomized parallel control group; the study is listed as single group.
Primary question
Among patients classified as having neoplastic disease by the PET reference assessment, how often did EUS-guided puncture identify malignancy? The registry defines this as sensitivity and says the performance analysis is by patient, not by lymph node.
The clinical question concerns the diagnostic contribution of puncturing PET-detected mediastinal lymph nodes and the possible consequences for subsequent cancer management. The registry rationale notes uncertainty about the impact of PET screening at different stages of cancer care. It proposes evaluating the combination of PET and echoendoscopy-guided puncture in different clinical contexts, including whether the procedure could replace more invasive diagnostic procedures and whether its findings could prompt a change in therapeutic management.
Those aims extend beyond the primary sensitivity endpoint. The registry also lists negative predictive value, agreement between therapeutic strategies at RCP1 and RCP2, and clinical utility in avoiding a more invasive procedure as secondary outcomes. Their numerical results are not reported in the registry record. Consequently, the available description establishes what the investigators intended to assess, but does not establish how often the procedure changed management or avoided another procedure.
3. Trial Design
This is a completed, single-center prospective diagnostic assessment sponsored by Institut Bergonié. The registry lists the study as single group, with no masking, and an enrollment of 75. Allocation is recorded as NA, so the record does not describe randomized allocation or a parallel treatment comparison. The study started on 2013-01-08 and its primary completion date is 2019-10-10.
The assessed procedure was guided puncture of mediastinal lymphadenopathy by echoendoscopy. PET was used to detect hypermetabolic lymph nodes and is identified in the primary endpoint description as the reference technique. The registry says EUS-guided puncture followed detection of lymph nodes by PET, and that PET was followed for 12 months. This structure is a diagnostic evaluation against a reference assessment, not a comparison of outcomes between two randomized treatment arms.
The registry describes a primary-endpoint population of 47 eligible and evaluable patients. It excludes patients with non-contributory histological results, puncture not carried out, or radiological monitoring not carried out. The overall enrollment and the primary-endpoint population therefore refer to different counts in the record; the reasons listed for endpoint exclusions should be kept in view when interpreting the diagnostic endpoint.
The record lists five outcome measures and includes secondary outcomes addressing negative predictive value, matching between therapeutic strategies RCP1/RCP2, and clinical utility in avoiding a more invasive procedure. It reports zero analyses. A detailed statistical analysis plan, the timing of any interim analyses, and a sample-size justification are not reported in the registry record. Planning illustrations based on an observed effect are not a description of this study’s single-group design and should not be interpreted as observed power.
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 | Hypermetabolic Mediastinal Lymph Nodes in PET, |
|---|---|
| STARTED | 75 |
| Group A : Biopsy Surgically Possible | 72 |
| Group B : Biopsy Not Surgically Possible | 3 |
| COMPLETED | 47 |
| NOT COMPLETED | 28 |
Reasons for not completing this period:
| Reason | Hypermetabolic Mediastinal Lymph Nodes in PET, |
|---|---|
| Protocol Violation | 2 |
| Puncture not carried out | 9 |
| Radiological monitoring not carried out | 5 |
| Non-contributory histological result | 12 |
Analysis population for the primary outcome, as defined in the registry: Patient eligible and evaluable for primary endpoint (N=47) (excluded patients with non-contributory histological results, puncture not carried out, radiological monitoring not carried out)
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 | Hypermetabolic Mediastinal Lymph Nodes in PET, |
|---|---|---|
| Participants analysed | 75 | |
| Age, Continuous | years | 63.01 (SD 13.64) |
| Sex: Female, Male: Female | Participants | 40 |
| Sex: Female, Male: Male | Participants | 35 |
| Race and Ethnicity Not Collected | Participants | — |
| Height | cm | 166.97 (SD 8.67) |
| Weight | kg | 72.53 (SD 16.46) |
| Therapeutic strategy (absence of documentation): Not available | Participants | 1 |
| Therapeutic strategy (absence of documentation): Surgery right from the start | Participants | 4 |
| Therapeutic strategy (absence of documentation): Chemotherapy or other carcinological treatment | Participants | 54 |
| Therapeutic strategy (absence of documentation): Non-carcinological management in case of documented benign pathology | Participants | 12 |
| Therapeutic strategy (absence of documentation): No treatment | Participants | 4 |
| Therapeutic strategy after documentation: Missing | Participants | 8 |
| Therapeutic strategy after documentation: Chemotherapy or other carcinological treatment | Participants | 20 |
| Therapeutic strategy after documentation: No treatment | Participants | 13 |
| T status (Classification of Malignant Tumors): T0 | Participants | 1 |
| T status (Classification of Malignant Tumors): T1 | Participants | 7 |
| T status (Classification of Malignant Tumors): T2 | Participants | 9 |
| T status (Classification of Malignant Tumors): T3 | Participants | 13 |
| T status (Classification of Malignant Tumors): T4 | Participants | 5 |
| T status (Classification of Malignant Tumors): TX | Participants | 2 |
| N status (Classification of Malignant Tumors): Missing | Participants | 6 |
| N status (Classification of Malignant Tumors): N0 | Participants | 11 |
| N status (Classification of Malignant Tumors): N+ | Participants | 17 |
| N status (Classification of Malignant Tumors): NX | Participants | 3 |
| M status (Classification of Malignant Tumors): Missing | Participants | 5 |
| M status (Classification of Malignant Tumors): M0 | Participants | 17 |
| M status (Classification of Malignant Tumors): M1 | Participants | 2 |
| M status (Classification of Malignant Tumors): Could not be evaluated for distant metastases | Participants | 13 |
| Total number of lymph nodes per patient | lymph nodes | 3.00 (1.00 to 5.00) |
6. Primary Endpoint
The registry lists the primary outcome as Sensitivity of Endoscopic Ultrasound-guided (EUS-guided) Puncture, measured over 12 months.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | 95% Confidence Interval |
| Unit | percentage |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the sensitivity of EUS-guided puncture, expressed as a percentage, with a 95% confidence interval and a 12-month timeframe. Sensitivity describes the proportion of patients who have the target condition according to a reference assessment and are identified as positive by the diagnostic procedure being evaluated. In this study, the registry defines the target condition using PET as the reference technique and asks whether EUS-guided puncture identifies malignancy among patients with neoplastic disease by that reference.
The endpoint is defined at the patient level, not the lymph-node level. The registry notes that in most cases only one lymph node was sampled. It also specifies that atypical, suspicious, and non-contributory EUS results do not count as a diagnosis of malignancy for the sensitivity definition. The primary-endpoint population excludes patients with non-contributory histology, a puncture not carried out, or radiological monitoring not carried out.
Sensitivity is useful for describing how often a diagnostic procedure detects disease among people classified as having disease by the reference method. It does not, on its own, describe how often a positive procedure result is correct, how often a negative result is correct, or whether use of the procedure changes management. Those are distinct questions, some of which are reflected in the listed secondary outcomes. The numerical sensitivity estimate and its confidence interval are not reported in the registry record, so the endpoint’s magnitude and precision cannot be assessed from the record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record defines a clinically relevant diagnostic question, but it does not report the numerical result for the primary endpoint. Although sensitivity and its 95% confidence interval are specified, neither estimate is reported in the registry record. The endpoint’s observed magnitude, direction relative to any benchmark, and precision therefore cannot be interpreted from the record. The study’s completed status does not substitute for the missing numerical result.
The denominator described for primary analysis is 47 eligible and evaluable patients. This population excludes patients with non-contributory histological results, puncture not carried out, or radiological monitoring not carried out. The registry separately lists enrollment of 75. The endpoint population is consequently a selected subset of the enrolled group according to the stated criteria. Without a numerical result or a fuller account of excluded participants, the extent to which these exclusions affect interpretation is not reported in the registry record.
The reference assessment is PET followed for 12 months. This matters because sensitivity depends on how the target condition is identified. The reported definition counts EUS-guided puncture as positive when it identifies malignancy and compares that classification with neoplastic disease according to the PET reference assessment. The definition excludes atypical, suspicious, and non-contributory results from a positive diagnosis. The record does not provide the underlying counts needed to understand how individual result categories contributed to the endpoint.
This is a single-group diagnostic assessment, not a like-for-like randomized comparison. Its primary question is diagnostic agreement with a reference method, rather than a treatment effect between allocated groups. The registry’s stated aims also include possible changes in therapeutic management and avoidance of more invasive procedures. Those aims cannot be judged from sensitivity alone, and numerical findings for the listed secondary outcomes are not reported in the registry record.
General statistical interpretation: a confidence interval expresses uncertainty around an estimate under the assumptions of the analysis. A narrower interval indicates greater precision, while a wider interval indicates less precision. Here, the registry specifies a 95% confidence interval but does not report its limits. Therefore, neither the estimate nor its precision can be assessed. No claim about diagnostic performance, clinical utility, or the value of the procedure follows from the study description alone.
There are serious adverse event figures in the record, including 34 affected among 47 at risk and zero deaths. These figures are safety descriptions, not evidence of a causal relationship to the procedure. The record does not report enough detail to determine timing, attribution, event overlap, or how the listed serious-event categories relate to each affected participant. Interpretation should remain limited to the counts and categories recorded.
9. Statistical Methods Explained
What does sensitivity describe?
General statistical explanation: sensitivity is the proportion of people who have a condition according to a chosen reference assessment and who are also classified as positive by the diagnostic procedure under evaluation. The registry applies this concept to patient-level results. PET is the reference technique, and EUS-guided puncture is the diagnostic procedure being assessed. The study description says PET was followed for 12 months.
The definition depends on the classification rules. In this record, a diagnosis of malignancy by EUS-guided puncture is counted as positive; atypical, suspicious, or non-contributory results are not treated as a positive diagnosis for the sensitivity calculation. The record says the analysis is by patient, not by lymph node, and notes that in most cases only one lymph node was taken. These details define what counts as a positive result and the unit being analyzed. The numerical patient counts classified as positive or negative are not reported in the registry record.
Why is the reference assessment important?
General statistical explanation: diagnostic accuracy is assessed relative to a reference method, and the choice and timing of that reference affect the meaning of the estimate. The registry identifies PET as the reference technique and specifies follow-up for 12 months. The resulting sensitivity is therefore sensitivity against the registry’s PET-based reference definition, not an assertion that the procedure detects an independently established truth under every possible diagnostic standard. The record does not describe further details of reference adjudication or how discordant findings were resolved.
What does a 95% confidence interval contribute?
General statistical explanation: an estimate alone gives a point summary, while a confidence interval communicates uncertainty around that estimate under the statistical model used. It helps readers distinguish a relatively precise estimate from one compatible with a broader range of values. The primary endpoint specifies a 95% confidence interval, but its bounds and the sensitivity estimate are not reported in the registry record. Thus, the requested interval cannot be used to evaluate precision or compatibility with any threshold.
The registry does not state the method used to construct the interval. Different methods can produce different intervals, particularly when data are limited or estimates lie near the possible boundaries. No particular interval procedure should be inferred from the endpoint label alone. The analysis method, treatment of missing data, and any adjustment approach are not reported in the registry record.
Why is the analysis population important?
The primary endpoint population is described as 47 eligible and evaluable patients. Patients with non-contributory histology, puncture not carried out, or radiological monitoring not carried out are excluded. Such exclusions define the set of participants contributing to the primary endpoint, but they can also affect how broadly an estimate applies. General statistical explanation: excluding participants after enrollment can make an analysis population differ from the population initially recruited, especially if exclusion is related to diagnostic findings or follow-up. The record does not give counts by exclusion reason or explain how these cases were handled in other analyses.
The overall enrollment is 75, while the primary-endpoint description identifies 47 eligible and evaluable patients. The record does not provide a participant flow account that reconciles those counts. It also does not state whether any sensitivity analyses included excluded participants, or how uncertain reference classifications were treated. These details are important for assessing the robustness of a diagnostic estimate.
Why do the study design and analysis need to match?
This study is listed as single group, with allocation recorded as NA. Its primary analysis is diagnostic: it compares the result of EUS-guided puncture with a reference assessment. It is not a randomized comparison of two treatment groups. General statistical explanation: an analysis intended for independent treatment arms does not automatically answer a single-group diagnostic question. Interpretation should follow the study’s design and endpoint rather than treating the diagnostic reference as a randomized control arm.
The record contains planning assumptions for illustrations based on an observed effect: 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 fraction of the observed effect. These are described as planning illustrations, not as the study’s design or observed power. The study itself is listed as single group. The record does not report its own sample-size justification or the assumptions used to choose enrollment.
What is not specified about the statistical plan?
The registry lists five outcome measures and zero analyses. The primary endpoint is defined, but the statistical methods for calculating it are not described in the record. A detailed analysis plan, interim analyses, multiplicity adjustment, missing-data procedures, and prespecified subgroup analyses are not reported in the registry record. The record also does not supply the numerical primary estimate or the component counts needed to reproduce it. Any interpretation should therefore distinguish the stated endpoint definition from an analysis result: the definition is present, but the numerical result and many implementation details are not.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists five outcome measures. Alongside sensitivity, the listed secondary outcomes include negative predictive value, matching between therapeutic strategies RCP1/RCP2, and clinical utility in avoiding a more invasive procedure. The record reports zero analyses, and numerical results for these secondary outcomes are not reported in the registry record. It does not identify a hierarchy among endpoints or describe an adjustment for testing multiple outcomes.
General statistical explanation: when several outcomes or comparisons are examined, the chance of at least one apparently notable finding can increase if each is interpreted separately. A prespecified hierarchy or multiplicity adjustment can help define how evidence is evaluated across outcomes. Whether either approach was used is not reported in the registry record, so no adjustment should be assumed.
The primary-endpoint population is stated as 47 eligible and evaluable patients, with exclusions for non-contributory histology, puncture not carried out, or radiological monitoring not carried out. The registry does not report the number excluded for each reason, a participant flow accounting for the enrollment of 75, or a missing-data strategy. It is therefore not possible to assess from the record whether missing or unevaluable cases were related to diagnostic findings or how their exclusion affected the endpoint.
The analysis population is described for the primary endpoint, but analysis populations for secondary outcomes are not reported in the registry record. Subgroup plans, interim analyses, and sensitivity analyses are also not reported. These omissions limit assessment of whether the analyses followed prespecified rules and whether results could be sensitive to alternative handling of incomplete diagnostic information.
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 |
|---|---|---|---|
| Hypermetabolic Mediastinal Lymph Nodes in PET, | 34 | 47 | 72.3% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Hypermetabolic Mediastinal Lymph Nodes in PET, | 0 of 47 |
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 |
|---|---|
| Hypermetabolic Mediastinal Lymph Nodes in PET, | 34 of 47 |
Most frequent serious adverse event terms
| Event term | Organ system | Hypermetabolic Mediastinal Lymph Nodes in PET, |
|---|---|---|
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 11 of 47 |
| General disorders and administration site conditions - Other, specify | General disorders | 4 of 47 |
| Anemia | Blood and lymphatic system disorders | 3 of 47 |
| Respiratory, thoracic and mediastinal disorders - Other, specify | Respiratory, thoracic and mediastinal disorders | 2 of 47 |
| Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | 1 of 47 |
| Heart failure | Cardiac disorders | 1 of 47 |
| Ascites | Gastrointestinal disorders | 1 of 47 |
| Esophageal stenosis | Gastrointestinal disorders | 1 of 47 |
| Gastrointestinal disorders - Other, specify | Gastrointestinal disorders | 1 of 47 |
| Kidney infection | Infections and infestations | 1 of 47 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Hypermetabolic Mediastinal Lymph Nodes in PET, |
|---|---|---|
| Alteration of the general condition | General disorders | 4 of 47 |
| Hemorragia | Vascular disorders | 4 of 47 |
| Anemia | Blood and lymphatic system disorders | 3 of 47 |
| Asthenia | General disorders | 3 of 47 |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 2 of 47 |
| Left inguinal hernia aggravation | Gastrointestinal disorders | 1 of 47 |
| Alopecia | Skin and subcutaneous tissue disorders | 1 of 47 |
| Ferriprive anemia on melena | Blood and lymphatic system disorders | 1 of 47 |
| Multifactorial anemia | Blood and lymphatic system disorders | 1 of 47 |
| Anorexia | Metabolism and nutrition disorders | 1 of 47 |
Serious events with the highest arm-level rate: neoplasms benign, malignant and unspecified (incl cysts and polyps) - other, specify (23.4%), general disorders and administration site conditions - other, specify (8.5%), anemia (6.4%), respiratory, thoracic and mediastinal disorders - other, specify (4.3%), blood and lymphatic system disorders - other, specify (2.1%).
The registry lists 47 participants at risk and 34 affected for both serious adverse events and other adverse events. It records zero deaths. The serious-event categories with the largest listed percentages are “Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify” at 23.4%, “General disorders and administration site conditions - Other, specify” at 8.5%, and “Anemia” at 6.4%. Other listed serious-event terms are respiratory, thoracic and mediastinal disorders - Other, specify at 4.3%, blood and lymphatic system disorders - Other, specify at 2.1%, and heart failure at 2.1%.
These are registry safety listings, not evidence that the procedure caused the events. The record does not report event timing, attribution, severity details beyond the serious-event classification, or whether participants experienced more than one event category. It also does not explain how the listed category percentages relate to the 34 affected participants. The figures should therefore be read as reported counts and category percentages, without treating categories as mutually exclusive or inferring a procedure-related risk.
The safety population and follow-up period for these adverse-event listings are not described beyond the counts at risk. The 12-month timeframe applies to the primary diagnostic endpoint description; the registry record does not establish that it is also the adverse-event observation period.
12. What the Result Does, and Does Not, Mean
The registry record supports a clear description of the intended diagnostic question: whether echoendoscopy-guided puncture identifies malignancy among patients classified as having neoplastic disease by PET followed for 12 months. It also specifies patient-level analysis and explains how atypical, suspicious, and non-contributory puncture results are treated in the sensitivity definition. These are useful details for understanding the intended endpoint.
However, the record does not report the numerical sensitivity estimate or its 95% confidence interval. It therefore does not show how often the procedure detected malignancy under the stated definition, nor how precise that estimate was. The completed status and enrollment count do not supply the missing diagnostic results. The same caution applies to the listed secondary outcomes: their descriptions establish the questions of interest, but their numerical findings are not reported in the registry record.
The study is single group and prospective, with PET serving as the reference assessment. It is not a randomized treatment comparison, so it does not estimate the effect of one assigned treatment versus another. The registry’s aims include potential changes in therapeutic management and avoidance of more invasive procedures, but the record does not report results that establish whether either occurred. Sensitivity, even if numerically available, would not by itself answer those management questions.
The endpoint population includes 47 eligible and evaluable patients, while enrollment is listed as 75. The registry identifies several exclusion reasons but does not provide counts for them or a participant flow account. This limits assessment of how endpoint exclusions may affect applicability. The safety listing includes serious and other adverse-event counts, but does not establish causality or provide event-level detail.
Accordingly, the record describes the study’s design, endpoint definition, and selected safety information, but does not provide enough numerical outcome information to judge diagnostic performance or clinical utility. No conclusion about whether the procedure should be used follows from these registry entries alone.
13. Why This Trial Matters Statistically
This study raises a statistical issue common to diagnostic research: the result depends on a defined target condition, a reference method, and rules for classifying the test under evaluation. Here, the registry identifies PET as the reference, specifies follow-up for 12 months, and defines sensitivity using patient-level results. It also clarifies that atypical, suspicious, and non-contributory puncture findings are not counted as a diagnosis of malignancy. Such definitions are essential for interpreting a diagnostic accuracy measure.
The record also illustrates the distinction between enrollment and the population contributing to a particular endpoint. Enrollment is 75, while the primary-endpoint population is described as 47 eligible and evaluable patients. Exclusions are attributed to non-contributory histology, puncture not carried out, or radiological monitoring not carried out. Without a detailed flow account or numerical results, readers cannot assess how those exclusions relate to the estimate, but recognizing the difference in populations is important.
Another statistical distinction is between diagnostic assessment and treatment comparison. The study is listed as single group, and PET functions as a reference rather than a randomized control arm. The primary question is therefore about classification against a reference, not comparative treatment efficacy. The separate aims concerning changes in management or avoiding invasive procedures require outcome information beyond a sensitivity estimate.
Finally, the registry record demonstrates why a prespecified endpoint description and a reported result are not interchangeable. The endpoint, timeframe, and confidence-interval type are stated, but the numerical estimate and interval are not reported. Without those values, readers cannot assess magnitude or precision. Transparent reporting of the analysis population, exclusions, endpoint counts, and uncertainty is necessary for a complete statistical interpretation.
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 important limitation for interpreting the registry record is that the numerical primary sensitivity estimate and its 95% confidence interval are not reported. The record therefore describes the endpoint without showing the result needed to assess diagnostic performance or precision. Numerical findings for the listed secondary outcomes are also not reported.
The primary-endpoint population is 47 eligible and evaluable patients, compared with overall enrollment of 75. The registry lists reasons for exclusion but does not provide counts by reason or a participant flow account. This makes it difficult to understand how the endpoint population was formed and whether excluded cases differed in ways relevant to diagnostic classification. The record does not describe missing-data handling or sensitivity analyses for excluded or unevaluable cases.
PET is identified as the reference technique and is followed for 12 months, but further details about reference classification and resolution of discordant findings are not reported in the registry record. The analysis is described as patient-level, with one lymph node taken in most cases, but the record does not provide the underlying patient-level diagnostic counts.
The single-group design is appropriate to the stated diagnostic assessment but does not provide a randomized treatment comparison. The record’s aims concerning therapeutic management changes and avoiding more invasive procedures cannot be assessed from the primary sensitivity definition alone. The statistical analysis plan, sample-size justification, interim analyses, multiplicity handling, and prespecified subgroup analyses are not reported in the registry record. The adverse-event listings also lack reported attribution and event-level detail, limiting causal interpretation.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Feasibility Study on the Contribution of Guided Puncture With Echoendoscopy — NCT01892501.
- Registry record last updated 2025-09-03; status last verified 2021-04.
- Results first posted 2021-04-27.
- 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.
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18. Record Summary
NCT01892501 is a completed, single-center prospective diagnostic assessment sponsored by Institut Bergonié. It lists enrollment of 75, single-group design, no masking, and allocation recorded as NA. The study dates are 2013-01-08 to primary completion on 2019-10-10.
The primary endpoint is sensitivity of EUS-guided puncture for PET-detected hypermetabolic mediastinal lymphadenopathy, expressed as a percentage with a 95% confidence interval over 12 months. PET is the reference technique. The endpoint population is described as 47 eligible and evaluable patients, with specified exclusions.
The registry record does not report the numerical primary endpoint result or its confidence interval. It lists five outcome measures, zero analyses, and secondary questions concerning negative predictive value, matching between therapeutic strategies, and avoiding more invasive procedures. Serious and other adverse-event listings each report 34 affected among 47 at risk, with zero deaths; the record does not establish causality.