Diagnostic Value of Transbronchial Lung Cryobiopsy

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion 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 - 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02579304
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

KU Leuven
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

jonas Yserbyt
Principal Investigator Affiliation Universitaire Ziekenhuizen Leuven
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries Belgium
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Interstitial Lung Disease
Additional Details

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.

Contact a Trial Team

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International Sites

UZ Leuven, Leuven, Belgium

Status

Address

UZ Leuven

Leuven, , 3000

Terms of Service

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