Interstitial Lung Disease
Conditions
Keywords
Cryobiopsy, lung biopsy, 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
Interventions
PROCEDURELung biopsy
transbronchial lung biopsy. First kryobiopsy, second open biopsy
Sponsors
University Hospital Tuebingen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* IIP suspected on clinical and radiologic grounds
Exclusion criteria
* Age \>80y and \<18y * FVC\< 55%, DCO\<35% * Platelet count \<100000/µl * acetylsalicylic acid, clopidogrel or equivalent during the last 5 days * INR \> l,3, * elevated PTT (\> 40 s) * documented pulmonary hypertension PAPS \>50mmHg * HR-CT highly suspicious for sarcoidosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of conclusive diagnosis after bronchoscopy with transbronchial cryobiopsy | two weeks |
Secondary
| Measure | Time frame |
|---|---|
| Rate of pneumothoraxes | 1 day |
| numer of exacerbations after biopsy | 6 weeks |
| Contribution of BAL and cryobiopsy to diagnosis | 2 weeks |
| Size of specimen | 2 weeks |
| numer of bleeding events | 1 day |
| Distribution of histological changes in the specimen | 2 weeks |
| Influence of the size of the cryoprobe in the primary endpoint | 2 weeks |
| Comparative group (out of trial) - who are referred for VATS directly ['positive control group'] | 6 weeks |
| Rate of exacerbations after cryobiopsy and after surgical biopsy | 6 weeks |
| Quality of specimen | 2 weeks |
Countries
Germany, Italy, Spain, United Kingdom
Outcome results
None listed