Cryobiopsy vs. VATS in Diagnosis of Interstitial Lung Diseases

Sponsor

Wissenschaftliches Institut Bethanien e.V (Other)

Overall Status

Completed

CT.gov ID

NCT01714518

Collaborator

(none)

Enrollment

Location

56.4

Actual Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Interstitial Lung Disease

Study Design

Study Type:

Observational

Actual Enrollment :

62 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Oct 16, 2012

Actual Primary Completion Date :

Jun 30, 2017

Actual Study Completion Date :

Jun 30, 2017

Arms and Interventions

Arm	Intervention/Treatment
ILD diagnosis Patients subjected to Cryobiopsy and/or VATS for diagnosis of interstitial lung disease

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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