Diagnostic Value of Transbronchial Lung Cryobiopsy

KU Leuven20 enrolled

Overview

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

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

Enrollment

Conditions

Interstitial Lung Disease

Interventions

transbronchial lung cryobiopsyPROCEDURE

bronchoscopic sampling

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

UZ Leuven

Leuven, Belgium

Outcomes

Primary Outcomes

histopathological agreement

Histopathological diagnostic intra-observer agreement between Video-assisted thoracosopic surgery biopsy and TBLC (kappa value)

Time frame: 2 years

Secondary Outcomes

procedural safety : bleeding

incidence of bleeding (number of case)

Time frame: periprocedural 1 hour

procedural safety : bleeding (2)

severity of bleeding (grade 1-2-3)

Time frame: periprocedural 1 hour

procedural safety : bleeding (3)

duration of bleeding (seconds)

Time frame: periprocedural 1 hour

procedural safety : penumothorax

pneumothorax rate (number of cases)

Time frame: periprocedural 1 hour

Data from ClinicalTrials.gov

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