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Manufacturer did not develop and deliver the necessary biopsy forceps needles in time
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| Name | Class |
|---|---|
| Chelsea and Westminster NHS Foundation Trust | OTHER |
| Heidelberg University | OTHER |
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A prospective diagnostic clinical study randomising patients undergoing endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA) of enlarged mediastinal and hilar lymph nodes to have sampling using the usual EBUS-TBNA needle or a novel biopsy forceps (EBUS-TBNB).
The study aims to establish whether the use of EBUS-TBNB can significantly increase the diagnostic yield over EBUS-TBNA, without an increase in complication rates.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EBUS-TBNA | Active Comparator | Sampling using endobronchial ultrasound guided transbronchial needle aspiration |
|
| EBUS-TBNB | Experimental | Sampling using endobronchial ultrasound guided transbronchial forceps biopsy needle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endobronchial ultrasound guided lymph node sampling | Device | Patients with enlarged mediastinal or hilar lymph nodes have these sampled under endobronchial ultrasound guidance using either the EBUS-TBNA needle or the EBUS-TBNB biopsy forceps. |
| Measure | Description | Time Frame |
|---|---|---|
| The percentage of lymph nodes sampled resulting in a definitive diagnosis (as defined in the protocol) in the two study arms. | The definition of a "definitive diagnosis" is dependant on the diagnosis and is clarified below:
| 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| The difference in the complication rate between the two study arms | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zaid Zoumot, MBBS, MRCP, MSc | Royal Brompton Hospital NHS Foundation Trust, Chelsea and Westminster Hospital NHS Fundation Trust | Study Director |
| Pallav L Shah, MD, FRCP | Royal Brompton Hospital NHS Foundation Trust, Chelsea and Westminster Hospital NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thoraxklinik, University of Heidelberg | Heidelberg | D-69126 | Germany | |||
| Chelsea and Westminster Hospital |
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| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D008223 | Lymphoma |
| D012507 | Sarcoidosis |
| D009164 | Mycobacterium Infections |
| ID | Term |
|---|---|
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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|
| London |
| SW10 9NH |
| United Kingdom |
| The Royal Brompton Hospital | London | SW3 6NP | United Kingdom |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D006968 | Hypersensitivity, Delayed |
| D006967 | Hypersensitivity |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |