Clinical Trial: Open Label Trial of Utility of Cryobiopsy in the Multidisciplinary Diagnosis of Idiopathic Interstitial Lung Disease
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Open Label Trial of Utility of Cryobiopsy in the Multidisciplinary Diagnosis of Idiopathic Interstitial Lung Disease
Brief Summary: A multicenter, multinational, prospective study to clarify, whether the addition of cryobiopsy can avoid surgical lung biopsy in a clinically relevant proportion of patients with suspected Idiopathic Interstitial Pneumonia
Detailed Summary:
Sponsor: University Hospital Tuebingen
Current Primary Outcome: Percentage of conclusive diagnosis after bronchoscopy with transbronchial cryobiopsy [ Time Frame: two weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- numer of bleeding events [ Time Frame: 1 day ]
- Rate of pneumothoraxes [ Time Frame: 1 day ]
- numer of exacerbations after biopsy [ Time Frame: 6 weeks ]
- Contribution of BAL and cryobiopsy to diagnosis [ Time Frame: 2 weeks ]
- Size of specimen [ Time Frame: 2 weeks ]
- Quality of specimen [ Time Frame: 2 weeks ]
- Distribution of histological changes in the specimen [ Time Frame: 2 weeks ]
- Influence of the size of the cryoprobe in the primary endpoint [ Time Frame: 2 weeks ]
- Comparative group (out of trial) - who are referred for VATS directly ['positive control group'] [ Time Frame: 6 weeks ]
- Rate of exacerbations after cryobiopsy and after surgical biopsy [ Time Frame: 6 weeks ]
Original Secondary Outcome: Same as current
Information By: University Hospital Tuebingen
Dates:
Date Received: May 2, 2015
Date Started: November 2014
Date Completion:
Last Updated: October 25, 2016
Last Verified: October 2016
