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

Not Applicable

Completed

• Conditions: Lung Nodules
• Interventions: Procedure: cryobiopsy

• Registration Number: NCT02196974
• Lead Sponsor: University of Calgary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2014-07-18
• Study First Submitted QC: 2014-07-18
• Study First Posted: 2014-07-22
• Status Verified: 2016-08
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Last Update Submitted: 2016-08-29
• Last Update Posted: 2016-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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.

  2. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
cryobiopsy	cryobiopsy	-

Primary Outcome Measures

Name	Time	Method
incremental diagnostic yield of cryobiopsy over the standard specimens	1 year after completion of recruitment

Trial Locations

Locations (1)

University of Calgary; 🇨🇦 Calgary, Alberta, Canada