Diagnostic Yield of Transbronchial Cryobiopsy in Diagnosis of Interstitial Lung Diseases

Not Applicable

• Conditions: Interstitial Lung Disease
• Interventions: Other: Transbronchial lung cryobiopsy

• Registration Number: NCT02235779
• Lead Sponsor: Laval University

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

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-08-26
• Study First Submitted QC: 2014-09-08
• Study First Posted: 2014-09-10
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-04
• Last Update Posted: 2021-03-08
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cryobiopsy	Transbronchial lung cryobiopsy	-

Primary Outcome Measures

Name	Time	Method
Overall diagnostic yield of cryobiopsy specimens in interstitial lung disease	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 Outcome Measures

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

Trial Locations

Locations (1)

Institut universitaire de cardiologie et de pneumologie de Québec; 🇨🇦 Québec, Canada