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Rationale: Lung cancer is the most commonly diagnosed cancer worldwide and is the most frequent cause of cancer death. Accurate staging is important because it directs treatment and prognosis. Mediastinal staging can be done by both EBUS-TBNA and EUS-FNA. These two techniques have a complementary diagnostic range and the combined procedure is suited for assessment of almost the entire mediastinum. In practice, when mediastinal tissue staging is indicated, endoscopists often perform either an EBUS or an EUS investigation (instead of the combined procedure). Second, frequently only one or two, by imaging suspected lymph node stations, are sampled (ie. targeted approach).
Objectives: main and secondary:
Study population: Patients with potentially operable and resectable NSCLC are eligible if there is an indication for mediastinal nodal sampling. Patients have an indication for EBUS-TBNA.
Intervention: Patients will undergo an EBUS investigation followed by EUS-B in the same session. During this single scope procedure, lymph nodes that are suspected on prior CT-PET imaging and on subsequent ultrasound are sampled.
Main study endpoint: The main study parameter is the sensitivity for locoregional disease (N2, N3, T4 disease) of complete endosonographic staging (by EBUS-TBNA and EUS-B-FNA) in comparison with EBUS staging alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| (suspected) NSCLC, mediastinal staging, endosonography | Patients with potentially medically operable and resectable NSCLC are eligible if there is an indication for pathological evaluation of mediastinal lymph nodes. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endosonography | Procedure | Complete endosonographic mediastinal staging is performed in 2 steps:
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| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity for locoregional disease (N2, N3, T4 disease). | Sensitivity is defined as number of true positives (pathologic proof of a nodal metastases) divided by the number of true positives and false negatives (thoracotomy with nodal dissection is the reference standard to detect false negatives). The main study parameter is the sensitivity for locoregional disease (N2, N3, T4 disease) of complete endosonographic staging (by EBUS-TBNA and EUS-B-FNA) in comparison with EBUS staging alone. In the event of pathological proof of mediastinal metastases (N2/N3) by endosonography patients are classified as having locally advanced disease (stage III) and the study stops. When no mediastinal metastases are found by endosonography, surgical verification will take place (reference standard). | from inclusion untill either pathological proof of mediastinal metastases by endospnography or 1 week after surgical verification |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity for locally advanced disease (N2-3 metastases, T4). Systematic assessment and sampling of mediastinal lymph nodes versus PET-CT directed assessment of the mediastinum. | Sensitivity for locally advanced disease (N2-3 metastases, T4) of systematic assessment and sampling of mediastinal lymph nodes in comparison to PET-CT directed assessment of the mediastinum (ie targeted approach). | from inclusion untill either pathological proof of mediastinal metastases by endosonography or 1 week after surgical verification |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with potentially operable and resectable NSCLC are eligible if there is an indication for mediastinal nodal sampling. Patients have an indication for EBUS-TBNA.
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| Name | Affiliation | Role |
|---|---|---|
| Jouke T Annema, MD, PhD | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Onze-Lieve-Vrouwen-Ziekenhuis | Aalst | Belgium | ||||
| Universitair Ziekenhuis Leuven |
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| Leuven |
| Belgium |
| Academic Medical Center | Amsterdam | North Holland | 1105AZ | Netherlands |
| Medisch Centrum Alkmaar | Alkmaar | Netherlands |
| Antoni van Leeuwenhoek ziekenhuis | Amsterdam | Netherlands |
| Vrije Universiteit Medisch Centrum | Amsterdam | Netherlands |
| Leids Universitair Medisch Centrum | Leiden | Netherlands |
| Universitair Medisch Centrum st Radboud | Nijmegen | Netherlands |
| Isala klinieken | Zwolle | Netherlands |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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