Diagnostic Yield of Transbronchial Cryobiopsy in Diagnosis of Interstitial Lung Diseases

DIagnostic Yield of Transbronchial Cryobiopsies in Subjects With Interstitial Lung Disease

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.

Study Overview

• Status: Recruiting
• Conditions: Interstitial Lung Disease
• Intervention / Treatment: Other: Transbronchial lung cryobiopsy

Detailed Description

See above

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Antoine Delage, MDCM; Phone Number: 418-656-4747; Email: antoine.delage@criucpq.ulaval.ca

Study Locations

• Canada
  • Québec, Canada, G1V 4G5
    • Recruiting
    • Institut Universitaire de cardiologie et de pneumologie de Quebec
    • Contact: Antoine Delage, MDCM; Phone Number: 418-656-4747; Email: antoine.delage@criucpq.ulaval.ca
    • Principal Investigator: Antoine Delage, MDCM
    • Sub-Investigator: Simon Martel, MD
    • Sub-Investigator: Steeve Provencher, MD
    • Sub-Investigator: Genevieve Dion, MD
    • Sub-Investigator: Philippe Joubert, MD
    • Sub-Investigator: Massimo Conti, MD
    • Sub-Investigator: Paula Ugalde, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Laval University
• Investigators: Study Chair: Antoine Delage, MDCM, Institut Universitaire de cardiologie et de pneumologie de Quebec

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: August 26, 2014
• First Submitted That Met QC Criteria: September 8, 2014
• First Posted (Estimate): September 10, 2014

Study Record Updates

• Last Update Posted (Actual): March 8, 2021
• Last Update Submitted That Met QC Criteria: March 4, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Cryobiopsy; ILD; Pulmonary fibrosis; Transbronchial
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial
• Other Study ID Numbers: CryobiopsieTBB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No