Status:
COMPLETED
Bronchoscopic Approach to the Peripheral Lung Nodule - Endobronchial Ultrasound, Electromagnetic Navigation and Cryobiopsy
Lead Sponsor:
University of Calgary
Conditions:
Lung Nodules
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief Summary
In patients with peripheral lung nodules, what is the additional diagnostic yield of biopsies obtained with flexible cryoprobes compared to standard techniques? For patients with peripheral nodules, w...
Eligibility Criteria
Inclusion
- 1\. Age \>18 years 2. Lung nodule (s) identified on CT scan 3. Clinical decision to obtain tissue biopsy of lung lesion 4. CT guided biopsy not preferred technique
- Previous negative CT guided biopsy
- Technically difficult nodule location
- Perceived high risk of pneumothorax or other complications
Exclusion
- 1\. Lack of informed consent 2. Nodule less than 1 cm or greater than 6 cm long axis 3. Significant mediastinal adenopathy. 4. No suspected sites of disease outside the thorax amenable to biopsy 5. Evidence of endobronchial abnormality on chest CT 6. Medical contraindication to bronchoscopy 7. Patients with lesions highly suspicious for lung cancer, potentially resectable with lobar or lesser resection and without significantly increased operative risk factors will not be entered into this study prior to surgical evaluation.
- 8\. Uncontrolled or irreversible coagulopathy
- platelets \<100
- INR \>1.3
- Use of clopidogrel in the 7 days prior to bronchoscopy 9. Confirmed or suspected pregnancy 10. Clinically unable to tolerate a pneumothorax or single-lung ventilation 11. Pacemaker or implanted cardiac defibrillator if it is felt that ENB is needed
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2016
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT02196974
Start Date
January 1 2013
End Date
August 1 2016
Last Update
August 31 2016
Active Locations (1)
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1
University of Calgary
Calgary, Alberta, Canada