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Cryobiopsy vs. VATS in Diagnosis of Interstitial Lung Diseases

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ClinicalTrials.gov Identifier: NCT01714518
Recruitment Status : Completed
First Posted : October 26, 2012
Last Update Posted : October 29, 2018
Sponsor:
Information provided by (Responsible Party):
Wissenschaftliches Institut Bethanien e.V

Study Description
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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
Interstitial Lung Disease

Study Design
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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 : October 16, 2012
Actual Primary Completion Date : June 30, 2017
Actual Study Completion Date : June 30, 2017

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Groups and Cohorts
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Group/Cohort
ILD diagnosis
Patients subjected to Cryobiopsy and/or VATS for diagnosis of interstitial lung disease


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Inpatients undergoing routine diagnosis of known or suspected interstitial lung disease
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01714518


Locations
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Germany
Bethanien Hospital, Clinic for Pneumology and Allergology, Center for Sleep and Respiratory Medicine
Solingen, NRW, Germany, 42699
Sponsors and Collaborators
Wissenschaftliches Institut Bethanien e.V
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Wissenschaftliches Institut Bethanien e.V
ClinicalTrials.gov Identifier: NCT01714518    
Other Study ID Numbers: WI_KryoVATS_80/2012
First Posted: October 26, 2012    Key Record Dates
Last Update Posted: October 29, 2018
Last Verified: October 2018
Keywords provided by Wissenschaftliches Institut Bethanien e.V:
Interstitial Lung Disease
Diagnosis
Cryobiopsy
Video-assisted thoracic surgery
Lung biopsy
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Interstitial
Respiratory Tract Diseases