Diagnostic Yield of Transbronchial Cryobiopsy in Diagnosis of Interstitial Lung Diseases

Interstitial Lung Disease Clinical Trial

Official title:

DIagnostic Yield of Transbronchial Cryobiopsies in Subjects With Interstitial Lung Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02235779
• Other study ID #: CryobiopsieTBB
• Status: Recruiting
• Phase: N/A
• Start date: August 2014
• Est. completion date: December 2021

Study information

• Verified date: March 2021
• Source: Laval University
• Contact: Antoine Delage, MDCM
• Phone: 418-656-4747
• Email: antoine.delage[@]criucpq.ulaval.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

See above

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial

Intervention

Other:
• Transbronchial lung cryobiopsy

Locations

Country	Name	City	State
Canada	Institut universitaire de cardiologie et de pneumologie de Québec	Québec

Sponsors (1)

Lead Sponsor	Collaborator
Laval University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall diagnostic yield of cryobiopsy specimens in interstitial lung disease	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.	After biopsy (up to 24 months)
Secondary	Complication rate of transbronchial cryobiopsy procedure	Assessment of complications related to cryoTBB: pneumothorax; hemorrage; other complications	Per-procedure and up to 24 hours after
Secondary	Number of diagnostic specimens of cryoTBB in comparison with surgical lung biopsy specimen	Diagnostic concordance between cryobiopsy specimen analysis and corresponding surgical lung biopsy done in same subjects (same lung/lobe)	After biopsy (up to 24 months)
Secondary	Inter-observer agreement for cryobiopsy specimens	Interobserver agreement rate between two different pathologists blinded to subject history/radiological record and surgical lung biopsy specimen.	After biopsy (up to 24 months)
Secondary	Size of cryobiopsy specimen	Size of TBB cryobiopsy specimen measured by two different pathologists responsible for its interpretation.	After biopsy (up to 24months)
Secondary	Quality of cyrobiopsy specimens	Pathological quality score of TBB cryobiopsy specimens (artefacts, size, etc.) as assessed by two different pathologists responsible for their interpretation.	After biopsy (up to 24 months)