Trial record 11 of 160 for:    Open Studies | "Lung Diseases, Interstitial"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by University Hospital Tuebingen
Sponsor:
Information provided by (Responsible Party):
Boeckeler, Michael, University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT01894113
First received: July 2, 2013
Last updated: July 11, 2013
Last verified: July 2013
  Purpose

The use of cryoprobes improves the diagnostic yield in transbronchial biopsies compared to forceps biopsies to diagnose an interstitial lung disease


Condition Intervention
Interstitial Lung Disease
Procedure: transbronchial lung biopsy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
Official Title: Prospective, Randomised Multicenter Study Comparing Transbronchial Forceps Biopsy With Cryobiopsy in Interstitial Lung Disease

Resource links provided by NLM:


Further study details as provided by University Hospital Tuebingen:

Primary Outcome Measures:
  • Diagnostic value of each biopsy procedure. It will be identified, how often biopsy contributed to the final diagnosis. [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Differences in the final diagnosis [ Time Frame: 24 Months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Bleeding None, Mild degree (suction <= 3min), Moderate (extraction> 3min), Severe (intervention: tamponade, surgery) [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 382
Study Start Date: January 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01894113

Contacts
Contact: Jürgen Hetzel, MD 0049-7071-29-82714 juergen.hetzel@med.uni-tuebingen.de
Contact: Michael Böckeler, MD 0049-7071-29-82714 michael.boeckeler@med.uni-tuebingen.de

Locations
Germany
University Hospital Tuebingen Recruiting
Tuebingen, Germany
Contact: Juergen Hetzel, MD    0049-7071-2982714    juergen.hetzel@med.uni-tuebingen.de   
Sub-Investigator: Michael Boeckeler, MD         
Sponsors and Collaborators
University Hospital Tuebingen
Investigators
Principal Investigator: Jürgen Hetzel, MD University Hospital Tuebingen
  More Information

No publications provided

Responsible Party: Boeckeler, Michael, Dr. med. Michael Böckeler, University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT01894113     History of Changes
Other Study ID Numbers: TBB2010
Study First Received: July 2, 2013
Last Updated: July 11, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

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

ClinicalTrials.gov processed this record on July 31, 2014