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

NCT02763540 | Completed DMC

• 2 other identifiers: 96072015-A01350-49
• Study Type: interventional
• Target: 21
• Locations: 2 countries
• Sites: 2

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.

Conditions

Non Definite IPF; Interstitial Lung Diseases

Keywords

ILD; Pathology; diagnosis; lung biopsy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (1)

Lung cryobiopsy

OTHER

Procedure: Lung cryobiopsy

Interventions

Lung cryobiopsy PROCEDURE

Transbronchial cryobiopsy

Also known as: Per endoscopy

Lung cryobiopsy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non IPF ILD eligible for surgical lung biopsy reviewed during multidisciplinary approach

You may not qualify if:

• Ineligible for lung biopsy: pulmonary hypertension, coagulation deficiency, FEV\<11, giant emphysematous bullae, hemodynamic instability severe hypoxia, general anesthetic ineligibility

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (2)

Arnaud de Villeneuve University Hospital

Montpellier, 34295, France

Location

S'Orsola-Malpighi hospital

Bologna, 40138, Italy

Location

Related Publications (6)

• 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.

  PMID: 31442081 BACKGROUND

• 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.

  PMID: 31535900 BACKGROUND

• 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.

  PMID: 32439734 BACKGROUND

• 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.

  PMID: 30864813 RESULT

• 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.

  PMID: 33209910 RESULT

• 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.

  PMID: 33717159 RESULT

MeSH Terms

Conditions

Lung Diseases, Interstitial; Disease

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Arnaud Bourdin, MD, PhD

  University Hospitals of Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2016
• First Posted: May 5, 2016
• Study Start: January 20, 2016
• Primary Completion: March 30, 2018
• Study Completion: June 25, 2018
• Last Updated: March 19, 2021

Record last verified: 2021-03

Locations

FR (1); IT (1)