Clinical trial NCT01714518: Cryobiopsy vs. VATS in Diagnosis of Interstitial Lung Diseases
Official title: Cryobiopsy vs. VATS: Efficiency and Safety in the Diagnosis of Interstitial Lung Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Interstitial Lung Disease
Keywords: Interstitial Lung Disease
Diagnosis
Cryobiopsy
Video-assisted thoracic surgery
Lung biopsy
Lead sponsor: Wissenschaftliches Institut Bethanien e.V
Sponsor class: OTHER
First posted: 2012-10-26
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Inpatients undergoing routine diagnosis of known or suspected interstitial lung disease

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.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Known or newly diagnosed interstitial lung disease (ILD)
* Indication for lung biopsy for definitive ILD diagnosis
* Informed Consent provided

Exclusion Criteria:

* Age \< 18 years
* Inability or contraindication to undergo any form of invasive diagnostic procedure associated with diagnosis of interstitial lung disease
* Severely restricted CO diffusion capacity (\<50%)
* Pregnancy, lactation
* Any medical, psychological or other condition restricting the patient's ability to provide informed consent
* Participation in another clinical trial

Primary outcomes:
measure: Rate of diagnostic cryobiopsies
timeFrame: up to 3 days
Secondary outcomes:
measure: Rate of complications during cryobiopsy
timeFrame: During and up to 48 hours after procedure
measure: Rate of complications during VATS
timeFrame: During and up to 10 days after procedure
Other outcomes:
Locations:
city: Solingen
country: Germany
facility: Bethanien Hospital, Clinic for Pneumology and Allergology, Center for Sleep and Respiratory Medicine
state: NRW
Study officials:
References:
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