Cryobiopsy vs. VATS in Diagnosis of Interstitial Lung Diseases

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01714518

Enrollment

Registered

2012-10-26

Start date

2012-10-16

Completion date

2017-06-30

Last updated

2018-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Interstitial Lung Disease

Keywords

Interstitial Lung Disease, Diagnosis, Cryobiopsy, Video-assisted thoracic surgery, Lung biopsy

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Rate of diagnostic cryobiopsies	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.

Secondary

Measure	Time frame	Description
Rate of complications during cryobiopsy	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	During and up to 10 days after procedure	Number of complications associated with VATS, divided into three categories of severity: mild/moderate/severe

Countries

Germany

Outcome results