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

Interstitial Lung Diseases Clinical Trial

— CryoPID  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02763540
• Other study ID #: 9607
• Secondary ID: 2015-A01350-49
• Status: Completed
• Phase: N/A
• Start date: January 20, 2016
• Est. completion date: June 25, 2018

Study information

• Verified date: March 2021
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: June 25, 2018
• Est. primary completion date: March 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Interstitial Lung Diseases
• Lung Diseases
• Lung Diseases, Interstitial
• Non Definite IPF

Intervention

Procedure:
• Lung cryobiopsy
Transbronchial cryobiopsy

Locations

Country	Name	City	State
France	Arnaud de Villeneuve University Hospital	Montpellier
Italy	S'Orsola-Malpighi hospital	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Countries where clinical trial is conducted

France,  Italy, 

References & Publications (6)

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). pii: 1902415. doi: 10.1183/13993003.02415-2019. Print 2020 May. — View 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. — View 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 — View 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 C — View 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. — View 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- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	for statistical analysis, 12 months after the first inclusion
Secondary	The percentage homology between diagnosis obtained by surgical biopsy and cryobiopsy with the multidisciplinary approach		one day after inclusion
Secondary	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
Secondary	The number of elementary lesions actually present in the two samples for the same patient		One day after inclusion
Secondary	The time of the gesture and the respective anesthetic complexities of each procedure		One day after inclusion
Secondary	The rate of adverse events		for statistical analysis, 12 months after the first inclusion