Feasibility, Safety and Diagnostic Value of Transbronchial Lung Cryobiopsy in the Work-up of Diffuse Interstitial Lung Diseases.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Interstitial Lung Disease
- Sponsor
- KU Leuven
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- histopathological agreement
- Last Updated
- 7 years ago
Overview
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
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.
Investigators
Yserbyt Jonas
MD
KU Leuven
Eligibility 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
- •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
Outcomes
Primary Outcomes
histopathological agreement
Time Frame: 2 years
Histopathological diagnostic intra-observer agreement between Video-assisted thoracosopic surgery biopsy and TBLC (kappa value)
Secondary Outcomes
- procedural safety : bleeding(periprocedural 1 hour)
- procedural safety : bleeding (2)(periprocedural 1 hour)
- procedural safety : bleeding (3)(periprocedural 1 hour)
- procedural safety : penumothorax(periprocedural 1 hour)