Le rôle de la Cryobiopsie Transbronchique Dans le Diagnostic Des Maladies Pulmoniares Interstitielles

University Hospital, Montpellier2 sites in 2 countries21 target enrollmentJanuary 20, 2016

ConditionsNon Definite IPF Interstitial Lung Diseases

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Non Definite IPF
Sponsor: University Hospital, Montpellier
Enrollment: 21
Locations: 2
Primary Endpoint: The percentage of concordant diagnoses between cryobiopsy and surgical lung biopsy.
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Pathological comparisons of surgical open lung biopsies and cryobiopsies in non-IPF ILD. Patients with non-IPF ILD eligible for an open lung biopsy will undergo cryobiopsy in the same time. Between observers agreement will be assessed for each pairs of samples.

Registry

clinicaltrials.gov

Start Date

January 20, 2016

End Date

June 25, 2018

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University Hospital, Montpellier

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Non IPF ILD eligible for surgical lung biopsy reviewed during multidisciplinary approach

Exclusion Criteria

•Ineligible for lung biopsy: pulmonary hypertension, coagulation deficiency, FEV\<11, giant emphysematous bullae, hemodynamic instability severe hypoxia, general anesthetic ineligibility

Outcomes

Primary Outcomes

The percentage of concordant diagnoses between cryobiopsy and surgical lung biopsy.

Time Frame: for statistical analysis, 12 months after the first inclusion

The gold standard is the consensual diagnosis between the two readers established from surgical biopsy

Secondary Outcomes

The time of the gesture and the respective anesthetic complexities of each procedure(One day after inclusion)
The rate of adverse events(for statistical analysis, 12 months after the first inclusion)
The percentage homology intra and inter observer for histopathological analysis of each type of sample by Mac Nemar test(for statistical analysis, 12 months after the first inclusion)
The number of elementary lesions actually present in the two samples for the same patient(One day after inclusion)
The percentage homology between diagnosis obtained by surgical biopsy and cryobiopsy with the multidisciplinary approach(one day after inclusion)