Interstitial Lung Disease
Conditions
Keywords
ILD, Pulmonary fibrosis, Cryobiopsy, Transbronchial
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
Interventions
Sponsors
Laval University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Canada
Contacts
Primary ContactAntoine Delage, MDCM
Outcome results
None listed