Cryobiopsy vs. VATS in Diagnosis of Interstitial Lung Diseases

Completed

• Conditions: Interstitial Lung Disease

• Registration Number: NCT01714518
• Lead Sponsor: Wissenschaftliches Institut Bethanien e.V

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-10-09
• Study Start: 2012-10-16
• Study First Submitted QC: 2012-10-23
• Study First Posted: 2012-10-26
• Primary Completion: 2017-06-30
• Study Completion: 2017-06-30
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-26
• Last Update Posted: 2018-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Bethanien Hospital, Clinic for Pneumology and Allergology, Center for Sleep and Respiratory Medicine; 🇩🇪 Solingen, NRW, Germany