DIagnostic Yield of Transbronchial Cryobiopsies in Subjects With Interstitial Lung Disease

Laval University1 site in 1 country50 target enrollmentAugust 2014

ConditionsInterstitial Lung Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Interstitial Lung Disease
Sponsor: Laval University
Enrollment: 50
Locations: 1
Primary Endpoint: Overall diagnostic yield of cryobiopsy specimens in interstitial lung disease
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Evaluation of diagnostic yield, feasibility and safety of transbronchial lung cryobiopsies done via bronchoscopy in the investigation of interstitial lung disease in comparison with videothoracoscopy-assisted surgical lung biopsy.

Detailed Description

See above

Registry

clinicaltrials.gov

Start Date

August 2014

End Date

December 2021

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Laval University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Volunteer subjects with interstitial lung disease in whom a surgical lung biopsy is planned for diagnostic investigation.

Exclusion Criteria

•Aged less than 18 y.o.
•Pregnancy
•Known coagulatoin disorder or blood dyscrasia
•Aaking antiplatelet agents other than aspirin or therapeutic anticoagulants drugs that cannot be safely discontinued to undergo lung biopsy
•Arterial oxgen pressure less than 60 mmHg on more than 2 liters per minute oxygen
•Known pulmonary hypertension defined as systolic PAP above 40 mmHg on echocardiography
•Unable to provide informed consent

Outcomes

Primary Outcomes

Overall diagnostic yield of cryobiopsy specimens in interstitial lung disease

Time Frame: After biopsy (up to 24 months)

Number of cryobiopsy specimens from which a specific diagnosis of interstitial lung disease can be ascertained, as assessed by a two different pathologists blinded to the known final diagnosis.

Secondary Outcomes

Complication rate of transbronchial cryobiopsy procedure(Per-procedure and up to 24 hours after)
Size of cryobiopsy specimen(After biopsy (up to 24months))
Number of diagnostic specimens of cryoTBB in comparison with surgical lung biopsy specimen(After biopsy (up to 24 months))
Inter-observer agreement for cryobiopsy specimens(After biopsy (up to 24 months))
Quality of cyrobiopsy specimens(After biopsy (up to 24 months))