Diagnostic Value of Transbronchial Lung Cryobiopsy

Feasibility, Safety and Diagnostic Value of Transbronchial Lung Cryobiopsy in the Work-up of Diffuse Interstitial Lung Diseases.

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02579304

Enrollment

Registered

2015-10-19

Start date

2019-01-31

Completion date

2023-06-30

Last updated

2018-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Interstitial Lung Disease

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.

Interventions

PROCEDUREtransbronchial lung cryobiopsy

bronchoscopic sampling

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
histopathological agreement	2 years	Histopathological diagnostic intra-observer agreement between Video-assisted thoracosopic surgery biopsy and TBLC (kappa value)

Secondary

Measure	Time frame	Description
procedural safety : bleeding	periprocedural 1 hour	incidence of bleeding (number of case)
procedural safety : bleeding (2)	periprocedural 1 hour	severity of bleeding (grade 1-2-3)
procedural safety : bleeding (3)	periprocedural 1 hour	duration of bleeding (seconds)
procedural safety : penumothorax	periprocedural 1 hour	pneumothorax rate (number of cases)

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026