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Completed

NCT Number: NCT02763540

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

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.

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Key information

Conditions

Non Definite IPF Disease Interstitial Lung Diseases Lung Diseases Lung Diseases, Interstitial Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arnaud de Villeneuve University Hospital, Montpellier, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lung cryobiopsy

Procedure

Transbronchial cryobiopsy

Other names: Per endoscopy

Primary outcomes

  1. The percentage of concordant diagnoses between cryobiopsy and surgical lung biopsy.

    Time frame: 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 outcomes

  1. The percentage homology between diagnosis obtained by surgical biopsy and cryobiopsy with the multidisciplinary approach

    Time frame: one day after inclusion

  2. 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

  3. The number of elementary lesions actually present in the two samples for the same patient

    Time frame: One day after inclusion

  4. The time of the gesture and the respective anesthetic complexities of each procedure

    Time frame: One day after inclusion

  5. The rate of adverse events

    Time frame: for statistical analysis, 12 months after the first inclusion

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Acronym: CryoPID

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
May 5, 2016
Registry last updated
Mar 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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