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Diagnostic Yield of Transbronchial Cryobiopsy in Diagnosis of Interstitial Lung Diseases

Primary Purpose

Interstitial Lung Disease

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Transbronchial lung cryobiopsy
Sponsored by
Laval University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Interstitial Lung Disease focused on measuring ILD, Pulmonary fibrosis, Cryobiopsy, Transbronchial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Institut universitaire de cardiologie et de pneumologie de QuébecRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Cryobiopsy

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Complication rate of transbronchial cryobiopsy procedure
Assessment of complications related to cryoTBB: pneumothorax hemorrage other complications
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)
Inter-observer agreement for cryobiopsy specimens
Interobserver agreement rate between two different pathologists blinded to subject history/radiological record and surgical lung biopsy specimen.
Size of cryobiopsy specimen
Size of TBB cryobiopsy specimen measured by two different pathologists responsible for its interpretation.
Quality of cyrobiopsy specimens
Pathological quality score of TBB cryobiopsy specimens (artefacts, size, etc.) as assessed by two different pathologists responsible for their interpretation.

Full Information

First Posted
August 26, 2014
Last Updated
March 4, 2021
Sponsor
Laval University
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1. Study Identification

Unique Protocol Identification Number
NCT02235779
Brief Title
Diagnostic Yield of Transbronchial Cryobiopsy in Diagnosis of Interstitial Lung Diseases
Official Title
DIagnostic Yield of Transbronchial Cryobiopsies in Subjects With Interstitial Lung Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 2014 (undefined)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laval University

4. Oversight

Data Monitoring Committee
No

5. 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.
Detailed Description
See above

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interstitial Lung Disease
Keywords
ILD, Pulmonary fibrosis, Cryobiopsy, Transbronchial

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antoine Delage, MDCM
Phone
418-656-4747
Email
antoine.delage@criucpq.ulaval.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antoine Delage, MDCM
Organizational Affiliation
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Official's Role
Study Chair
Facility Information:
Facility Name
Institut universitaire de cardiologie et de pneumologie de Québec
City
Québec
ZIP/Postal Code
G1V 4G5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antoine Delage, MDCM
Phone
418-656-4747
Email
antoine.delage@criucpq.ulaval.ca
First Name & Middle Initial & Last Name & Degree
Antoine Delage, MDCM
First Name & Middle Initial & Last Name & Degree
Simon Martel, MD
First Name & Middle Initial & Last Name & Degree
Steeve Provencher, MD
First Name & Middle Initial & Last Name & Degree
Genevieve Dion, MD
First Name & Middle Initial & Last Name & Degree
Philippe Joubert, MD
First Name & Middle Initial & Last Name & Degree
Massimo Conti, MD
First Name & Middle Initial & Last Name & Degree
Paula Ugalde, MD

12. IPD Sharing Statement

Learn more about this trial

Diagnostic Yield of Transbronchial Cryobiopsy in Diagnosis of Interstitial Lung Diseases

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