Diagnostic Value of Transbronchial Lung Cryobiopsy

Interstitial Lung Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02579304
• Other study ID #: UZLPNE1015
• Status: Not yet recruiting
• Start date: January 2019
• Est. completion date: June 2023

Study information

• Verified date: May 2018
• Source: Katholieke Universiteit Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: June 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial

Intervention

Procedure:
• transbronchial lung cryobiopsy
bronchoscopic sampling

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Katholieke Universiteit Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	histopathological agreement	Histopathological diagnostic intra-observer agreement between Video-assisted thoracosopic surgery biopsy and TBLC (kappa value)	2 years
Secondary	procedural safety : bleeding	incidence of bleeding (number of case)	periprocedural 1 hour
Secondary	procedural safety : bleeding (2)	severity of bleeding (grade 1-2-3)	periprocedural 1 hour
Secondary	procedural safety : bleeding (3)	duration of bleeding (seconds)	periprocedural 1 hour
Secondary	procedural safety : penumothorax	pneumothorax rate (number of cases)	periprocedural 1 hour