Navigation Endoscopy to Reach Indeterminate Lung Nodules Versus Trans-Thoracic Needle Aspiration
-
- STATUS
- Recruiting
-
- participants needed
- 258
-
- sponsor
- Vanderbilt-Ingram Cancer Center
Summary
This study will evaluate which procedure is the best for patients referred for
- a
computed tomography guidedbiopsy ("CT-guidedbiopsy ") which consists of sampling thenodule 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 thenodule .
Description
- Endpoints
-
- Primary
To evaluate diagnostic yield
- Secondary
-
- To evaluate rate of
pneumothorax . - To evaluate rate of
pneumothorax requiringchest 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-guidedbronchoscopy and CT for CT-guidedbiopsy . - 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.
- To evaluate rate of
Details
Condition |
Lung |
---|---|
Age | 18years - 100years |
Treatment |
CT-Guided |
Clinical Study Identifier | NCT04250194 |
Sponsor | Vanderbilt-Ingram Cancer Center |
Last Modified on | 19 February 2024 |
How to participate?
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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