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Clinical Trials/NCT02196974
NCT02196974CompletedNot Applicable

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

University of Calgary1 site in 1 country27 target enrollmentStarted: January 2013Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
27
Locations
1
Primary Endpoint
incremental diagnostic yield of cryobiopsy over the standard specimens
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to 99 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Age >18 years
  • •Lung nodule (s) identified on CT scan
  • •Clinical decision to obtain tissue biopsy of lung lesion
  • •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

  • •Lack of informed consent
  • •Nodule less than 1 cm or greater than 6 cm long axis
  • •Significant mediastinal adenopathy.
  • •No suspected sites of disease outside the thorax amenable to biopsy
  • •Evidence of endobronchial abnormality on chest CT
  • •Medical contraindication to bronchoscopy
  • •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
  • •Confirmed or suspected pregnancy
  • •Clinically unable to tolerate a pneumothorax or single-lung ventilation
  • •Pacemaker or implanted cardiac defibrillator if it is felt that ENB is needed

Outcomes

Primary Outcomes

incremental diagnostic yield of cryobiopsy over the standard specimens

Time Frame: 1 year after completion of recruitment

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Paul MacEachern

Clinical Assistant Professor

University of Calgary

Study Sites (1)

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