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Diagnostic Value of Transbronchial Lung Cryobiopsy

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ClinicalTrials.gov Identifier: NCT02579304
Recruitment Status : Not yet recruiting
First Posted : October 19, 2015
Last Update Posted : May 24, 2018
Sponsor:
Information provided by (Responsible Party):
Yserbyt Jonas, KU Leuven

Brief Summary:
Evaluating the diagnostic value of transbronchial lung cryobiopsy (TBLC) as well as its procedural feasibility and safety in a prospective series of 20 patients with diffuse interstitial lung diseases (DILD) who are referred for invasive histopathological diagnostics

Condition or disease Intervention/treatment
Interstitial Lung Disease Procedure: transbronchial lung cryobiopsy

Detailed Description:

Before one is able to state that TBLC is a technique that is an alternative for VATS biopsy, the diagnostic value of TBLC should be assessed and the value of the histopathological sampling should be compared with what is achieved by surgical lung biopsy. For this purpose direct comparison between VATS biopsy and TBLC is unavoidable. By including TBLC in the work-up of patients with DILD in which histopathological assessment is indicated (as proposed by MDD), we want to assess 3 major points of concern.

Agreement for the histopathological diagnosis between VATS biopsy and TBLC. Value of TBLC in the specific diagnosis in ILD.


Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Feasibility, Safety and Diagnostic Value of Transbronchial Lung Cryobiopsy in the Work-up of Diffuse Interstitial Lung Diseases.
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine



Intervention Details:
  • Procedure: transbronchial lung cryobiopsy
    bronchoscopic sampling


Primary Outcome Measures :
  1. histopathological agreement [ Time Frame: 2 years ]
    Histopathological diagnostic intra-observer agreement between Video-assisted thoracosopic surgery biopsy and TBLC (kappa value)


Secondary Outcome Measures :
  1. procedural safety : bleeding [ Time Frame: periprocedural 1 hour ]
    incidence of bleeding (number of case)

  2. procedural safety : bleeding (2) [ Time Frame: periprocedural 1 hour ]
    severity of bleeding (grade 1-2-3)

  3. procedural safety : bleeding (3) [ Time Frame: periprocedural 1 hour ]
    duration of bleeding (seconds)

  4. procedural safety : penumothorax [ Time Frame: periprocedural 1 hour ]
    pneumothorax rate (number of cases)


Biospecimen Retention:   Samples Without DNA
transbronchial lung biopsies


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
interstitial lung disease, fibrotic or non-fibrotic
Criteria

Inclusion Criteria:

  • - Case of DILD presented at the MDD
  • Referral for VATS biopsy as advised by MDD.
  • Informed consent available
  • Age > 18
  • FVC > 50%pred
  • DLCO > 40%pred
  • PaO2 > 65 mmHg, pCO2 < 45 mmHg
  • No exclusion criteria

Exclusion Criteria:

  • - Age > 75
  • PAPS >40mmHg as measured on transthoracic cardiac ultrasound
  • Platelet count <100000/µl
  • INR > 1.4
  • BMI >30
  • Diffuse bullous lung disease
  • Active anti-platelet or anticoagulant treatment
  • Active heart failure or unstable coronary heart disease
  • Patients unfit for VATS under general anaesthesia as assessed by the surgeon and/or anesthesiologist

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02579304


Locations
Belgium
UZ Leuven
Leuven, Belgium, 3000
Sponsors and Collaborators
KU Leuven
Investigators
Principal Investigator: jonas Yserbyt University Hospitals Leuven

Responsible Party: Yserbyt Jonas, MD, KU Leuven
ClinicalTrials.gov Identifier: NCT02579304     History of Changes
Other Study ID Numbers: UZLPNE1015
First Posted: October 19, 2015    Key Record Dates
Last Update Posted: May 24, 2018
Last Verified: May 2018

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Interstitial
Respiratory Tract Diseases