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Open Label Trial of Utility of Cryobiopsy in the Multidisciplinary Diagnosis of Idiopathic Interstitial Lung Disease

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ClinicalTrials.gov Identifier: NCT02563730
Recruitment Status : Unknown
Verified October 2016 by Boeckeler, Michael, University Hospital Tuebingen.
Recruitment status was:  Recruiting
First Posted : September 30, 2015
Last Update Posted : October 26, 2016
Sponsor:
Information provided by (Responsible Party):
Boeckeler, Michael, University Hospital Tuebingen

Brief Summary:
A multicenter, multinational, prospective study to clarify, whether the addition of cryobiopsy can avoid surgical lung biopsy in a clinically relevant proportion of patients with suspected Idiopathic Interstitial Pneumonia

Condition or disease Intervention/treatment Phase
Interstitial Lung Disease Procedure: Lung biopsy Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Open Label Trial of Utility of Cryobiopsy in the Multidisciplinary Diagnosis of Idiopathic Interstitial Lung Disease
Study Start Date : November 2014
Estimated Primary Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Lung biopsy
assess the additional diagnostic value of cryobiopsy in patients with suspected Idiopathic Interstitial Pneumonia (IIP). Cryoprobe vs VATS
Procedure: Lung biopsy
transbronchial lung biopsy. First kryobiopsy, second open biopsy




Primary Outcome Measures :
  1. Percentage of conclusive diagnosis after bronchoscopy with transbronchial cryobiopsy [ Time Frame: two weeks ]

Secondary Outcome Measures :
  1. numer of bleeding events [ Time Frame: 1 day ]
  2. Rate of pneumothoraxes [ Time Frame: 1 day ]
  3. numer of exacerbations after biopsy [ Time Frame: 6 weeks ]
  4. Contribution of BAL and cryobiopsy to diagnosis [ Time Frame: 2 weeks ]
  5. Size of specimen [ Time Frame: 2 weeks ]
  6. Quality of specimen [ Time Frame: 2 weeks ]
  7. Distribution of histological changes in the specimen [ Time Frame: 2 weeks ]
  8. Influence of the size of the cryoprobe in the primary endpoint [ Time Frame: 2 weeks ]
  9. Comparative group (out of trial) - who are referred for VATS directly ['positive control group'] [ Time Frame: 6 weeks ]
  10. Rate of exacerbations after cryobiopsy and after surgical biopsy [ Time Frame: 6 weeks ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • IIP suspected on clinical and radiologic grounds

Exclusion Criteria:

  • Age >80y and <18y
  • FVC< 55%, DCO<35%
  • Platelet count <100000/µl
  • acetylsalicylic acid, clopidogrel or equivalent during the last 5 days
  • INR > l,3,
  • elevated PTT (> 40 s)
  • documented pulmonary hypertension PAPS >50mmHg
  • HR-CT highly suspicious for sarcoidosis

Information from the National Library of Medicine

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): NCT02563730


Locations
Germany
Ruhrlandklinik Recruiting
Essen, Germany, 45239
Contact: Ulrich Costabel    0201-433-4021      
Contact: Kaid Darwiche         
Thoraxklinik Recruiting
Heidelberg, Germany, 69126
Contact: Michael Kreuter, PD    06221/396 0      
University Hospital Tuebingen Recruiting
Tuebingen, Germany
Contact: Juergen Hetzel, MD    0049-7071-2982714    juergen.hetzel@med.uni-tuebingen.de   
Sub-Investigator: Michael Boeckeler, MD         
Italy
Ospedale G.B. Morgagni Recruiting
Forlì, Italy, 47100
Contact: Poletti, Prof.    0543 735452      
Spain
Respiratory Department Hospital of Santa Creu i Sant Pau Recruiting
Barcelona, Spain, 08025
Contact: Alfons Torrego    (+34) 93 556 59 72      
United Kingdom
Royal Brompton Hospital Recruiting
London, United Kingdom, SW3 6LR
Contact: Athol Wells    +44 (0)20 7352 8121      
Sponsors and Collaborators
University Hospital Tuebingen

Responsible Party: Boeckeler, Michael, MD, University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT02563730     History of Changes
Other Study ID Numbers: CRYO-VATS
First Posted: September 30, 2015    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016

Keywords provided by Boeckeler, Michael, University Hospital Tuebingen:
Cryobiopsy
lung biopsy
interstitial lung disease

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