Pathological Comparisons of Surgical Open Lung Biopsies and Cryobiopsies in Non-IPF ILD

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02763540

Acronym

CryoPID

Enrollment

Registered

2016-05-05

Start date

2016-01-20

Completion date

2018-06-25

Last updated

2021-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Interstitial Lung Diseases, Non Definite IPF

Keywords

ILD, Pathology, diagnosis, lung biopsy

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.

Interventions

PROCEDURELung cryobiopsy

Transbronchial cryobiopsy

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
The percentage of concordant diagnoses between cryobiopsy and surgical lung biopsy.	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

Measure	Time frame
The percentage homology between diagnosis obtained by surgical biopsy and cryobiopsy with the multidisciplinary approach	one day after 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 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

Countries

France, Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026