Cryobiopsy vs. VATS in Diagnosis of Interstitial Lung Diseases

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Wissenschaftliches Institut Bethanien e.V
Sponsor:
Information provided by (Responsible Party):
Wissenschaftliches Institut Bethanien e.V
ClinicalTrials.gov Identifier:
NCT01714518
First received: October 9, 2012
Last updated: February 3, 2014
Last verified: February 2014
  Purpose

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
Interstitial Lung Disease

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Cryobiopsy vs. VATS: Efficiency and Safety in the Diagnosis of Interstitial Lung Diseases

Resource links provided by NLM:


Further study details as provided by Wissenschaftliches Institut Bethanien e.V:

Primary Outcome Measures:
  • Rate of diagnostic cryobiopsies [ Time Frame: up to 3 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: During and up to 48 hours after procedure ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Number of complications associated with VATS, divided into three categories of severity: mild/moderate/severe


Estimated Enrollment: 30
Study Start Date: October 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
ILD diagnosis
Patients subjected to Cryobiopsy and/or VATS for diagnosis of interstitial lung disease

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01714518

Contacts
Contact: Marcel Treml, Dr. marcel.treml@klinik-bethanien.de

Locations
Germany
Bethanien Hospital, Clinic for Pneumology and Allergology, Center for Sleep and Respiratory Medicine Recruiting
Solingen, NRW, Germany, 42699
Contact: Priegnitz, Dr. med.    +49-212-63-6662      
Principal Investigator: Winfried J Randerath, Prof. Dr. med.         
Sub-Investigator: Christina Priegnitz, Dr. med.         
Sub-Investigator: Lars Hagmeyer, Dr. med.         
Sponsors and Collaborators
Wissenschaftliches Institut Bethanien e.V
  More Information

Publications:

Responsible Party: Wissenschaftliches Institut Bethanien e.V
ClinicalTrials.gov Identifier: NCT01714518     History of Changes
Other Study ID Numbers: WI_KryoVATS_80/2012
Study First Received: October 9, 2012
Last Updated: February 3, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by Wissenschaftliches Institut Bethanien e.V:
Interstitial Lung Disease
Diagnosis
Cryobiopsy
Video-assisted thoracic surgery
Lung biopsy

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Interstitial
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 22, 2014