Interstitial Lung DiseaseNCT02579304
Diagnostic Value of Transbronchial Lung Cryobiopsy
An observational study of Interstitial Lung Disease, run by KU Leuven at 1 site in Belgium.
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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Interstitial Lung Disease
- What is being tested?
- transbronchial lung cryobiopsy
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2019to Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: interstitial lung disease, fibrotic or non-fibrotic
Who may be able to join
- - 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
Who cannot join
- - Age > 75
- PAPS >40mmHg as measured on transthoracic cardiac ultrasound
- Platelet count <100000/µl
- INR > 1.4
- BMI >30
- Diffuse bullous lung disease
Show all 9Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility, Safety and Diagnostic Value of Transbronchial Lung Cryobiopsy in the Work-up of Diffuse Interstitial Lung Diseases.
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
Read the 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.
- Conditions
- Interstitial Lung Disease
- Being tested
- transbronchial lung cryobiopsy
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transbronchial lung cryobiopsyProcedure or surgery
bronchoscopic sampling
What is being measured
The primary outcome is the main question the study is designed to answer.
histopathological agreement
Histopathological diagnostic intra-observer agreement between Video-assisted thoracosopic surgery biopsy and TBLC (kappa value)
Measured: 2 years
Secondary outcomes (4)
procedural safety : bleeding
incidence of bleeding (number of case)
Measured: periprocedural 1 hour
procedural safety : bleeding (2)
severity of bleeding (grade 1-2-3)
Measured: periprocedural 1 hour
procedural safety : bleeding (3)
duration of bleeding (seconds)
Measured: periprocedural 1 hour
procedural safety : penumothorax
pneumothorax rate (number of cases)
Measured: periprocedural 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2015 (estimated)
- Study startJan 2019 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial Lung DiseaseStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yserbyt Jonas, KU Leuven
- Investigators
- jonas Yserbyt, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02579304
- Sponsor's protocol ID
- UZLPNE1015
- Status last verified
- May 2018
- First submitted
- 12 Oct 2015
- Last updated
- 24 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Safety and Diagnostic Value of Transbronchial Lung Cryobiopsy in the Work-up of Diffuse Interstitial Lung Diseases.
- ClinicalTrials.gov ID
- NCT02579304
- Acronym / sponsor ID
- UZLPNE1015
- Conditions
- Interstitial Lung Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- Jan 2019 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 19 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- interstitial lung disease, fibrotic or non-fibrotic
Key inclusion criteria (8 listed)
- - Case of DILD presented at the MDD
- Referral for VATS biopsy as advised by MDD.
- Informed consent available
- Age > 18
- FVC > 50%pred
Key exclusion criteria (9 listed)
- - Age > 75
- PAPS >40mmHg as measured on transthoracic cardiac ultrasound
- Platelet count <100000/µl
- INR > 1.4
- BMI >30
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transbronchial lung cryobiopsybronchoscopic sampling | Procedure or surgery | – |
Primary outcome
histopathological agreement
Time frame: 2 years
Histopathological diagnostic intra-observer agreement between Video-assisted thoracosopic surgery biopsy and TBLC (kappa value)
4 secondary outcomes
procedural safety : bleeding
Time frame: periprocedural 1 hour
procedural safety : bleeding (2)
Time frame: periprocedural 1 hour
procedural safety : bleeding (3)
Time frame: periprocedural 1 hour
procedural safety : penumothorax
Time frame: periprocedural 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
jonas Yserbyt principal investigator
Universitaire Ziekenhuizen KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Interstitial Lung Disease, run by KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
histopathological agreement (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2018.