Diagnostic Value of Transbronchial Lung Cryobiopsy

NCT ID: NCT02579304

Last Updated: 2018-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-31

Study Completion Date

2023-06-30

Brief Summary

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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

Detailed Description

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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.

Conditions

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Interstitial Lung Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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transbronchial lung cryobiopsy

bronchoscopic sampling

Intervention Type PROCEDURE

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Yserbyt Jonas

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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jonas Yserbyt

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhuizen KU Leuven

Locations

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UZ Leuven

Leuven, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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UZLPNE1015

Identifier Type: -

Identifier Source: org_study_id

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