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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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

Detailed Summary:

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.


Sponsor: University Hospital Tuebingen

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

Original Primary Outcome: Same as current

Current Secondary Outcome: Differences in the final diagnosis [ Time Frame: 24 Months ]

Original Secondary Outcome: Same as current

Information By: University Hospital Tuebingen

Dates:
Date Received: July 2, 2013
Date Started: January 2012
Date Completion:
Last Updated: May 2, 2015
Last Verified: May 2015