Interstitial Lung DiseaseTRABISNCT01894113
Prospective, Randomised Multicenter Study Comparing the Efficacy of Transbronchial Forceps Biopsy With Cryobiopsy to Diagnose Interstitial Lung Disease.
A study testing transbronchial lung biopsy in people with Interstitial Lung Disease, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
The use of cryoprobes improves the diagnostic yield in transbronchial biopsies compared to forceps biopsies to diagnose an interstitial lung disease Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interstitial Lung Disease
- What is being tested?
- transbronchial lung biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 382 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2012to May 2014
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical indications for biopsy of interstitial lung disease
- Age over 18 years
- Signed consent
Who cannot join
- Risk of bleeding / ongoing anticoagulation
- Oxygen saturation <90% - despite delivery of 2l oxygen / min
- Underlying cardiac disease (unstable angina, myocardial infarction during the last month, congestive heart failure)
- Pulmonary hypertension, PAP sys> 50mmHg
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Randomised Multicenter Study Comparing Transbronchial Forceps Biopsy With Cryobiopsy in Interstitial Lung Disease
The use of cryoprobes improves the diagnostic yield in transbronchial biopsies compared to forceps biopsies to diagnose an interstitial lung disease
Read the detailed description
Endoscopic biopsy currently plays only a minor role for the diagnosis of interstitial lung disease. However, in some cases obtaining lung tissue is necessary to establish a final diagnosis. The current standard procedure is transbronchial forceps biopsy - if not sufficient: surgical lung biopsy. Transbronchial lung biopsy bears essential limitations however:
- Small tissue sample
- Limited evaluability of the material caused by forceps-induced crush artifacts
In cryobiopsy the cryoprobe´s tip is being cooled and thereby cools the surrounding tissue to approximately minus 89 degrees Celsius. Subsequently, the frozen probe is retracted with the frozen tissue being attached onto the frozen probe's tip. When applied in the central airways, cryobiopsy proved to deliver large specimens of good quality, which may exceed forceps biopsies in terms of diagnostic yield. Pilot studies on transbronchial cryobiopsy showed that same advantages as seen in the endobronchial use.
- Conditions
- Interstitial Lung Disease
- Being tested
- transbronchial lung biopsy
- Keywords
- interstitial lung disease, transbronchial biopsy, 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 biopsyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| transbronchial forceps lung biopsy | Active comparator | transbronchial lung biopsy forceps Receives: Procedure: transbronchial lung biopsy |
| transbronchail cryo lung biopsy | Active comparator | transbronchial lungbiopsy with cryoprobe Receives: Procedure: transbronchial lung biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic value of each biopsy procedure. It will be identified, how often biopsy contributed to the final diagnosis.
Measured: 24 months
Secondary outcomes (1)
Differences in the final diagnosis
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2013 (estimated)
- Study startJan 2012
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Interstitial Lung DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 382 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Boeckeler, Michael, University Hospital Tuebingen
- Investigators
- Jürgen Hetzel, MD, Principal investigator, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01894113
- Sponsor's protocol ID
- TBB2010
- Acronym
- TRABIS
- Status last verified
- May 2015
- First submitted
- 2 Jul 2013
- Last updated
- 5 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Hetzel J, Eberhardt R, Petermann C, Gesierich W, Darwiche K, Hagmeyer L, Muche R, Kreuter M, Lewis R, Ehab A, Boeckeler M, Haentschel M. Bleeding risk of transbronchial cryobiopsy compared to transbronchial forceps biopsy in interstitial lung disease - a prospective, randomized, multicentre cross-over trial. Respir Res. 2019 Jul 5;20(1):140. doi: 10.1186/s12931-019-1091-1.
PubMed 31277659
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomised Multicenter Study Comparing Transbronchial Forceps Biopsy With Cryobiopsy in Interstitial Lung Disease
- ClinicalTrials.gov ID
- NCT01894113
- Acronym / sponsor ID
- TRABIS / TBB2010
- Conditions
- Interstitial Lung Disease
- Keywords
- interstitial lung disease, transbronchial biopsy, cryobiopsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 382 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 9 Jul 2013 (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.
The use of cryoprobes improves the diagnostic yield in transbronchial biopsies compared to forceps biopsies to diagnose an interstitial lung disease
Detailed description
Endoscopic biopsy currently plays only a minor role for the diagnosis of interstitial lung disease. However, in some cases obtaining lung tissue is necessary to establish a final diagnosis. The current standard procedure is transbronchial forceps biopsy - if not sufficient: surgical lung biopsy. Transbronchial lung biopsy bears essential limitations however:
- Small tissue sample
- Limited evaluability of the material caused by forceps-induced crush artifacts
In cryobiopsy the cryoprobe´s tip is being cooled and thereby cools the surrounding tissue to approximately minus 89 degrees Celsius. Subsequently, the frozen probe is retracted with the frozen tissue being attached onto the frozen probe's tip. When applied in the central airways, cryobiopsy proved to deliver large specimens of good quality, which may exceed forceps biopsies in terms of diagnostic yield. Pilot studies on transbronchial cryobiopsy showed that same advantages as seen in the endobronchial use.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| transbronchial forceps lung biopsy | Active comparator | Procedure: transbronchial lung biopsytransbronchial lung biopsy forceps |
| transbronchail cryo lung biopsy | Active comparator | Procedure: transbronchial lung biopsytransbronchial lungbiopsy with cryoprobe |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical indications for biopsy of interstitial lung disease
- Age over 18 years
- Signed consent
Key exclusion criteria (4 listed)
- Risk of bleeding / ongoing anticoagulation
- Oxygen saturation <90% - despite delivery of 2l oxygen / min
- Underlying cardiac disease (unstable angina, myocardial infarction during the last month, congestive heart failure)
- Pulmonary hypertension, PAP sys> 50mmHg
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 biopsy | Procedure or surgery | transbronchail cryo lung biopsy, transbronchial forceps lung biopsy |
Primary outcome
Diagnostic value of each biopsy procedure. It will be identified, how often biopsy contributed to the final diagnosis.
Time frame: 24 months
1 secondary outcome
Differences in the final diagnosis
Time frame: 24 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2015.
- Derived from this study: PubMed 31277659Hetzel J, Eberhardt R, Petermann C, Gesierich W, Darwiche K, Hagmeyer L, Muche R, Kreuter M, Lewis R, Ehab A, Boeckeler M, Haentschel M. Bleeding risk of transbronchial cryobiopsy compared to transbronchial forceps biopsy in interstitial lung disease - a prospective, randomized, multicentre cross-over trial. Respir Res. 2019 Jul 5;20(1):140. doi: 10.1186/s12931-019-1091-1.
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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.
Jürgen Hetzel, MD principal investigator
University Hospital Tuebingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transbronchial lung biopsy in people with Interstitial Lung Disease, run by University Hospital Tuebingen at 1 site in Germany.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 5 May 2015. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Diagnostic value of each biopsy procedure. It will be identified, how often biopsy contributed to the final diagnosis. (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01894113, which also lists 1 linked publication.
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 5 May 2015; AzTrials last refreshed its copy on 4 Nov 2026.