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

Not Applicable

Completed

• Conditions: Non Definite IPF; Interstitial Lung Diseases
• Interventions: Procedure: Lung cryobiopsy

• Registration Number: NCT02763540
• Lead Sponsor: University Hospital, Montpellier

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-20
• Study First Submitted: 2016-04-13
• Study First Submitted QC: 2016-05-03
• Study First Posted: 2016-05-05
• Primary Completion: 2018-03-30
• Study Completion: 2018-06-25
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-16
• Last Update Posted: 2021-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lung cryobiopsy	Lung cryobiopsy	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

S'Orsola-Malpighi hospital; 🇮🇹 Bologna, Italy

Arnaud de Villeneuve University Hospital; 🇫🇷 Montpellier, France