Bronchoscopic Approach to the Peripheral Lung Nodule - Endobronchial Ultrasound, Electromagnetic Navigation and Cryobiopsy

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02196974

Enrollment

Registered

2014-07-22

Start date

2013-01-31

Completion date

2016-08-31

Last updated

2016-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Nodules

Keywords

bronchoscopy, lung nodule, diagnosis, cryobiopsy

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, we hypothesize use of the cryoprobe will allow larger samples of tissue to be obtained and therefore, will increase the diagnostic yield over conventional techniques

Interventions

PROCEDUREcryobiopsy

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

Inclusion criteria

* 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 criteria

* 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

Design outcomes

Primary

Measure	Time frame
incremental diagnostic yield of cryobiopsy over the standard specimens	1 year after completion of recruitment

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026