Diagnostic Yield of Transbronchial Cryobiopsy in Diagnosis of Interstitial Lung Diseases

Sponsor

Laval University (Other)

Overall Status

Recruiting

CT.gov ID

NCT02235779

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Interstitial Lung Disease	Other: Transbronchial lung cryobiopsy	N/A

Detailed Description

See above

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

DIagnostic Yield of Transbronchial Cryobiopsies in Subjects With Interstitial Lung Disease

Study Start Date :

Aug 1, 2014

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: Cryobiopsy	Other: Transbronchial lung cryobiopsy

Arm

Intervention/Treatment

Other: Cryobiopsy

Other: Transbronchial lung cryobiopsy

Outcome Measures

Primary Outcome Measures

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

Complication rate of transbronchial cryobiopsy procedure [Per-procedure and up to 24 hours after]
Assessment of complications related to cryoTBB: pneumothorax hemorrage other complications
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.
Size of cryobiopsy specimen [After biopsy (up to 24months)]
Size of TBB cryobiopsy specimen measured by two different pathologists responsible for its interpretation.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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