Clinical trial NCT02763540: Pathological Comparisons of Surgical Open Lung Biopsies and Cryobiopsies in Non-IPF ILD
Official title: Le rôle de la Cryobiopsie Transbronchique Dans le Diagnostic Des Maladies Pulmoniares Interstitielles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non Definite IPF
Interstitial Lung Diseases
Keywords: ILD
Pathology
diagnosis
lung biopsy
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2016-05-05
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: The percentage of concordant diagnoses between cryobiopsy and surgical lung biopsy.
timeFrame: for statistical analysis, 12 months after the first inclusion
Secondary outcomes:
measure: The percentage homology between diagnosis obtained by surgical biopsy and cryobiopsy with the multidisciplinary approach
timeFrame: one day after inclusion
measure: The percentage homology intra and inter observer for histopathological analysis of each type of sample by Mac Nemar test
timeFrame: for statistical analysis, 12 months after the first inclusion
measure: The number of elementary lesions actually present in the two samples for the same patient
timeFrame: One day after inclusion
measure: The time of the gesture and the respective anesthetic complexities of each procedure
timeFrame: One day after inclusion
measure: The rate of adverse events
timeFrame: for statistical analysis, 12 months after the first inclusion
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Arnaud de Villeneuve University Hospital
city: Bologna
country: Italy
facility: S'Orsola-Malpighi hospital
Study officials:
affiliation: University Hospitals of Montpellier
name: Arnaud Bourdin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.