Clinical Trial: Cryobiopsy vs. VATS in Diagnosis of Interstitial Lung Diseases

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Cryobiopsy vs. VATS: Efficiency and Safety in the Diagnosis of Interstitial Lung Diseases

Brief Summary: The purpose of this study is to assess efficiency and safety of cryobiopsy compared to video-assisted thoracoscopic lung biopsy (VATS) in diagnosis of interstitial lung diseases (ILD). To that end, this non-interventional study prospectively collects data from patients undergoing routine diagnosis of ILD. In some of those patients less invasive diagnostic approaches do not yield a definitive diagnosis. Thus, they will ultimately be subjected to VATS if this procedure is reasonable. The information gained by this study will help to assess the significance of cryobiopsy in contrast to VATS in this particular disease group.

Detailed Summary:
Sponsor: Wissenschaftliches Institut Bethanien e.V

Current Primary Outcome: Rate of diagnostic cryobiopsies [ Time Frame: up to 3 days ]

For the individual study participant, the result of the cryobiopsy (whether it is diagnostically helpful, i.e. "diagnostic" or not, i.e. "inconclusive") will be documented when it is available, which will be within 3 days. The overall number of diagnostic cryobiopsies will be calculated once the study is complete.


Original Primary Outcome: Rate of diagnostic cryobiopsies [ Time Frame: Individual results of cryobiopsies documented 3 days after procedure. Overall rate available at end of study (anticipated Dec 2013) ]

Based on all cases, the rate of diagnostic cryobiopsies is calculated (i.e. the percentage of cases in which no additional VATS was needed to arrive at a definitive diagnosis)


Current Secondary Outcome:

  • Rate of complications during cryobiopsy [ Time Frame: During and up to 48 hours after procedure ]
    Number of complications associated with cryobiopsy, divided into three categories of severity: mild/moderate/severe
  • Rate of complications during VATS [ Time Frame: During and up to 10 days after procedure ]
    Number of complications associated with VATS, divided into three categories of severity: mild/moderate/severe


Original Secondary Outcome: Same as current

Information By: Wissenschaftliches Institut Bethanien e.V

Dates:
Date Received: October 9, 2012
Date Started: October 2012
Date Completion: June 2017
Last Updated: January 5, 2017
Last Verified: January 2017