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

Primary Purpose

Non Definite IPF, Interstitial Lung Diseases

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Lung cryobiopsy
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Non Definite IPF focused on measuring ILD, Pathology, diagnosis, lung biopsy

Eligibility Criteria

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

Sites / Locations

  • Arnaud de Villeneuve University Hospital
  • S'Orsola-Malpighi hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Lung cryobiopsy

Arm Description

Outcomes

Primary Outcome Measures

The percentage of concordant diagnoses between cryobiopsy and surgical lung biopsy.
The gold standard is the consensual diagnosis between the two readers established from surgical biopsy

Secondary Outcome Measures

The percentage homology between diagnosis obtained by surgical biopsy and cryobiopsy with the multidisciplinary approach
The percentage homology intra and inter observer for histopathological analysis of each type of sample by Mac Nemar test
The number of elementary lesions actually present in the two samples for the same patient
The time of the gesture and the respective anesthetic complexities of each procedure
The rate of adverse events

Full Information

First Posted
April 13, 2016
Last Updated
March 16, 2021
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT02763540
Brief Title
Pathological Comparisons of Surgical Open Lung Biopsies and Cryobiopsies in Non-IPF ILD
Acronym
CryoPID
Official Title
Le rôle de la Cryobiopsie Transbronchique Dans le Diagnostic Des Maladies Pulmoniares Interstitielles
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
January 20, 2016 (Actual)
Primary Completion Date
March 30, 2018 (Actual)
Study Completion Date
June 25, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Definite IPF, Interstitial Lung Diseases
Keywords
ILD, Pathology, diagnosis, lung biopsy

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Lung cryobiopsy
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Lung cryobiopsy
Other Intervention Name(s)
Per endoscopy
Intervention Description
Transbronchial cryobiopsy
Primary Outcome Measure Information:
Title
The percentage of concordant diagnoses between cryobiopsy and surgical lung biopsy.
Description
The gold standard is the consensual diagnosis between the two readers established from surgical biopsy
Time Frame
for statistical analysis, 12 months after the first inclusion
Secondary Outcome Measure Information:
Title
The percentage homology between diagnosis obtained by surgical biopsy and cryobiopsy with the multidisciplinary approach
Time Frame
one day after inclusion
Title
The percentage homology intra and inter observer for histopathological analysis of each type of sample by Mac Nemar test
Time Frame
for statistical analysis, 12 months after the first inclusion
Title
The number of elementary lesions actually present in the two samples for the same patient
Time Frame
One day after inclusion
Title
The time of the gesture and the respective anesthetic complexities of each procedure
Time Frame
One day after inclusion
Title
The rate of adverse events
Time Frame
for statistical analysis, 12 months after the first inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arnaud Bourdin, MD, PhD
Organizational Affiliation
University Hospitals of Montpellier
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arnaud de Villeneuve University Hospital
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
S'Orsola-Malpighi hospital
City
Bologna
ZIP/Postal Code
40138
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
31442081
Citation
Romagnoli M, Colby TV, Suehs CM, Vachier I, Molinari N, Bourdin A. Cryobiopsy Compared with Surgical Lung Biopsy in ILD: Reply to Maldonado et al., Froidure et al., Bendstrup et al., Agarwal et al., Richeldi et al., Rajchgot et al., and Quadrelli et al. Am J Respir Crit Care Med. 2019 Oct 1;200(7):944-946. doi: 10.1164/rccm.201906-1252LE. No abstract available.
Results Reference
background
PubMed Identifier
31535900
Citation
Bourdin A, Suehs CM, Colby TV, Vachier I, Molinari N, Romagnoli M. Reply to Wand et al.: Role of Transbronchial Cryobiopsy in Interstitial Lung Diseases: An Ongoing Tale. Am J Respir Crit Care Med. 2020 Jan 15;201(2):260-261. doi: 10.1164/rccm.201909-1736LE. No abstract available.
Results Reference
background
PubMed Identifier
32439734
Citation
Bourdin A, Romagnoli M, Gamez AS, Hireche K, Berthet JP, Mallet JP, Vachier I, Nava S, Reynaud P, Molinari N, Suehs C. Careful consideration of the bleeding caused by transbronchial lung cryobiopsies. Eur Respir J. 2020 May 21;55(5):1902415. doi: 10.1183/13993003.02415-2019. Print 2020 May. No abstract available.
Results Reference
background
PubMed Identifier
30864813
Citation
Romagnoli M, Colby TV, Berthet JP, Gamez AS, Mallet JP, Serre I, Cancellieri A, Cavazza A, Solovei L, Dell'Amore A, Dolci G, Guerrieri A, Reynaud P, Bommart S, Zompatori M, Dalpiaz G, Nava S, Trisolini R, Suehs CM, Vachier I, Molinari N, Bourdin A. Poor Concordance between Sequential Transbronchial Lung Cryobiopsy and Surgical Lung Biopsy in the Diagnosis of Diffuse Interstitial Lung Diseases. Am J Respir Crit Care Med. 2019 May 15;199(10):1249-1256. doi: 10.1164/rccm.201810-1947OC.
Results Reference
result
PubMed Identifier
33209910
Citation
Suehs C, Bourdin A, Vachier I, Molinari N, Romagnoli M. Transbronchial cryobiopsy in the diagnosis of interstitial lung diseases: methodologies and perspectives from the Cryo-PID and COLDICE studies. Ann Transl Med. 2020 Oct;8(20):1330. doi: 10.21037/atm-20-2814. No abstract available.
Results Reference
result
PubMed Identifier
33717159
Citation
Reynaud P, Ahmed E, Serre I, Knabe L, Bommart S, Suehs C, Vachier I, Berthet JP, Romagnoli M, Vernisse C, Mallet JP, Gamez AS, Bourdin A. Club Cell Loss as a Feature of Bronchiolization in ILD. Front Immunol. 2021 Feb 26;12:630096. doi: 10.3389/fimmu.2021.630096. eCollection 2021.
Results Reference
result

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

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