Cryobiopsy vs. VATS in Diagnosis of Interstitial Lung Diseases

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.

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Key information

Conditions

Interstitial Lung Disease Disease Lung Diseases Lung Diseases, Interstitial Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bethanien Hospital, Clinic for Pneumology and Allergology, Center for Sleep and Respiratory Medicine

Solingen, North Rhine-Westphalia, 42699, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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.

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Wissenschaftliches Institut Bethanien e.V

Other

Registry information

Official study title

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

Important dates

Study start: 2012
Primary completion: 2017
Study completion: 2017
First posted: Oct 26, 2012
Registry last updated: Oct 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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