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EBUS-TBNA is often the sole diagnostic test applied in patients with stage IV lung cancer. A limitation of the TBNA needle when using a 22 Gauge needle is the limited ability to procure adequate histological samples. Although a larger 19 Ga needle can procure histological samples as demonstrated by the conventional 19 Ga needle, published data are not existing with respect to molecular diagnostics. A new nitinol-based 19 Ga needle has been developed for EBUS-TBNA. Given the frequent usage of 22 Ga needles for molecular diagnostics and the recent technical advancements in 19 Ga needle technology, we conduct a RCT to compare the performance of both needle types.
All patients with (suspected) stage IV lung carcinoma identified on spiral computed tomography scan and requiring an EBUS-TBNA investigation to obtain intrathoracic hilar or mediastinal lymph node tissue for diagnosis, subtyping and genotyping of lung cancer are eligible for participation in this study. Procedural technique : patients undergo an EBUS-TBNA procedure with either the Flex 19 Ga needle or the 22 Ga needle ; all procedures are performed using a linear array echoendosope under moderate sedation (standard practice). Primary endpoint of the study is the presence of core tissue that is defined as a continuous string of material as observed on the microscopic examination. Secondary endpoints are elements relevant to molecular analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 19 Ga EBUS-TBNA needle | Experimental | needle aspiration by a flexible 19 Ga needle (Olympus) |
|
| 22 Ga EBUS-TBNA needle | Active Comparator | needle aspiration by a 22 Ga needle (Olympus) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EBUS-TBNA needle | Device | tissue sampling |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tissue core | Descriptive tissue characteristics of tumor sample | 14 months |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor cellularity per area of diagnostic tissue | Objective pathologic measurement of tumor density | 14 months |
| Quantity of DNA extracted | Objective measurement of the amount of DNA |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christophe Dooms | Contact | christophe.dooms@uzleuven.be |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals KU Leuven | Recruiting | Leuven | 3000 | Belgium |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 14 months |
| Success rate of Next Generation Sequencing | Feasibility of NGS testing | 14 months |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |