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

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ClinicalTrials.gov Identifier: NCT01894113
Recruitment Status : Completed
First Posted : July 9, 2013
Last Update Posted : May 5, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The use of cryoprobes improves the diagnostic yield in transbronchial biopsies compared to forceps biopsies to diagnose an interstitial lung disease

Condition or disease Intervention/treatment
Interstitial Lung Disease Procedure: transbronchial lung biopsy

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 382 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: Prospective, Randomised Multicenter Study Comparing Transbronchial Forceps Biopsy With Cryobiopsy in Interstitial Lung Disease
Study Start Date : January 2012
Primary Completion Date : May 2014
Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: transbronchial forceps lung biopsy
transbronchial lung biopsy forceps
Procedure: transbronchial lung biopsy
Active Comparator: transbronchail cryo lung biopsy
transbronchial lungbiopsy with cryoprobe
Procedure: transbronchial lung biopsy


Outcome Measures

Primary Outcome Measures :
  1. Diagnostic value of each biopsy procedure. It will be identified, how often biopsy contributed to the final diagnosis. [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Differences in the final diagnosis [ Time Frame: 24 Months ]

Other Outcome Measures:
  1. Bleeding None, Mild degree (suction <= 3min), Moderate (extraction> 3min), Severe (intervention: tamponade, surgery) [ Time Frame: 24 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01894113


Locations
Germany
University Hospital Tuebingen
Tuebingen, Germany
Sponsors and Collaborators
University Hospital Tuebingen
Investigators
Principal Investigator: Jürgen Hetzel, MD University Hospital Tuebingen
More Information

Responsible Party: Boeckeler, Michael, Dr. med. Michael Böckeler, University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT01894113     History of Changes
Other Study ID Numbers: TBB2010
First Posted: July 9, 2013    Key Record Dates
Last Update Posted: May 5, 2015
Last Verified: May 2015

Keywords provided by Boeckeler, Michael, University Hospital Tuebingen:
interstitial lung disease
transbronchial biopsy
cryobiopsy

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Interstitial
Respiratory Tract Diseases