Navigation Endoscopy to Reach Indeterminate Lung Nodules Versus Trans-Thoracic Needle Aspiration
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- STATUS
- Recruiting
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- participants needed
- 258
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- sponsor
- Vanderbilt-Ingram Cancer Center
Summary
This study will evaluate which procedure is the best for patients referred for biopsy of a lung nodule (growth in the lung) meeting the size and location requirements of the protocol. Two different procedures are available for lung nodule biopsy:
- a computed tomography guided biopsy ("CT-guided biopsy") which consists of sampling the nodule from the "outside-in", through the chest wall with CT guidance, and
- navigation bronchoscopy, which is a procedure using technology designed to guide a catheter through the natural airway route (wind-pipe and bronchi) to access the nodule.
Description
- Endpoints
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- Primary
To evaluate diagnostic yield
- Secondary
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- To evaluate rate of pneumothorax.
- To evaluate rate of pneumothorax requiring chest tube placement.
- To evaluate clinically significant bleeding (defined by bleeding requiring intervention).
- To evaluate need for hospitalization after procedure.
- To evaluate duration of the procedure.
- To evaluate procedural factors associated with improved yield (type of biopsy, number of biopsies, use of radial ultrasound, presence of a bronchus sign, biopsy site).
- To evaluate need for additional nodule biopsy.
- To evaluate need for additional procedure for staging.
- To evaluate radiation exposure from fluoroscopy-guided bronchoscopy and CT for CT-guided biopsy.
- To evaluate need for F-Nav during navigation bronchoscopy.
- To evaluate bronchoscopy yield defined as the combination of the primary endpoint (navigation diagnostic yield) and yield from endobronchial ultrasound-guided mediastinal and/or hilar lymph node biopsies.
Details
| Condition | Lung Nodule |
|---|---|
| Age | 18-100 years |
| Treatment | CT-Guided Biopsy, Navigation bronchoscopy |
| Clinical Study Identifier | NCT04250194 |
| Sponsor | Vanderbilt-Ingram Cancer Center |
| Last Modified on | 19 February 2024 |
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