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Prospective, Randomised Multicenter Study Comparing the Efficacy of Transbronchial Forceps Biopsy With Cryobiopsy to Diagnose Interstitial Lung Disease.

Prospective, Randomised Multicenter Study Comparing Transbronchial Forceps Biopsy With Cryobiopsy in Interstitial Lung Disease

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01894113
Acronym
TRABIS
Enrollment
382
Registered
2013-07-09
Start date
2012-01-31
Completion date
2014-05-31
Last updated
2015-05-05

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

Conditions

Interstitial Lung Disease

Keywords

interstitial lung disease, transbronchial biopsy, cryobiopsy

Brief summary

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.

Interventions

Sponsors

University Hospital Tuebingen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Clinical indications for biopsy of interstitial lung disease 2. Age over 18 years 3. Signed consent

Exclusion criteria

1. Risk of bleeding / ongoing anticoagulation 2. Oxygen saturation \<90% - despite delivery of 2l oxygen / min 3. Underlying cardiac disease (unstable angina, myocardial infarction during the last month, congestive heart failure) 4. Pulmonary hypertension, PAP sys\> 50mmHg

Design outcomes

Primary

MeasureTime frame
Diagnostic value of each biopsy procedure. It will be identified, how often biopsy contributed to the final diagnosis.24 months

Secondary

MeasureTime frame
Differences in the final diagnosis24 Months

Other

MeasureTime frame
Bleeding None, Mild degree (suction <= 3min), Moderate (extraction> 3min), Severe (intervention: tamponade, surgery)24 months

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026