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OpenTrials
Completed

NCT Number: NCT02196974

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

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

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Calgary

Calgary, Alberta, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • 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

Treatment and study plan

Cryobiopsy

Procedure

Primary outcomes

  1. incremental diagnostic yield of cryobiopsy over the standard specimens

    Time frame: 1 year after completion of recruitment

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jul 22, 2014
Registry last updated
Aug 31, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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