<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01714518</url>
  </required_header>
  <id_info>
    <org_study_id>WI_KryoVATS_80/2012</org_study_id>
    <nct_id>NCT01714518</nct_id>
  </id_info>
  <brief_title>Cryobiopsy vs. VATS in Diagnosis of Interstitial Lung Diseases</brief_title>
  <official_title>Cryobiopsy vs. VATS: Efficiency and Safety in the Diagnosis of Interstitial Lung Diseases</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wissenschaftliches Institut Bethanien e.V</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wissenschaftliches Institut Bethanien e.V</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess efficiency and safety of cryobiopsy compared to&#xD;
      video-assisted thoracoscopic lung biopsy (VATS) in diagnosis of interstitial lung diseases&#xD;
      (ILD). To that end, this non-interventional study prospectively collects data from patients&#xD;
      undergoing routine diagnosis of ILD. In some of those patients less invasive diagnostic&#xD;
      approaches do not yield a definitive diagnosis. Thus, they will ultimately be subjected to&#xD;
      VATS if this procedure is reasonable. The information gained by this study will help to&#xD;
      assess the significance of cryobiopsy in contrast to VATS in this particular disease group.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 16, 2012</start_date>
  <completion_date type="Actual">June 30, 2017</completion_date>
  <primary_completion_date type="Actual">June 30, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of diagnostic cryobiopsies</measure>
    <time_frame>up to 3 days</time_frame>
    <description>For the individual study participant, the result of the cryobiopsy (whether it is diagnostically helpful, i.e. &quot;diagnostic&quot; or not, i.e. &quot;inconclusive&quot;) 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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of complications during cryobiopsy</measure>
    <time_frame>During and up to 48 hours after procedure</time_frame>
    <description>Number of complications associated with cryobiopsy, divided into three categories of severity: mild/moderate/severe</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of complications during VATS</measure>
    <time_frame>During and up to 10 days after procedure</time_frame>
    <description>Number of complications associated with VATS, divided into three categories of severity: mild/moderate/severe</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">62</enrollment>
  <condition>Interstitial Lung Disease</condition>
  <arm_group>
    <arm_group_label>ILD diagnosis</arm_group_label>
    <description>Patients subjected to Cryobiopsy and/or VATS for diagnosis of interstitial lung disease</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Inpatients undergoing routine diagnosis of known or suspected interstitial lung disease&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Known or newly diagnosed interstitial lung disease (ILD)&#xD;
&#xD;
          -  Indication for lung biopsy for definitive ILD diagnosis&#xD;
&#xD;
          -  Informed Consent provided&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 18 years&#xD;
&#xD;
          -  Inability or contraindication to undergo any form of invasive diagnostic procedure&#xD;
             associated with diagnosis of interstitial lung disease&#xD;
&#xD;
          -  Severely restricted CO diffusion capacity (&lt;50%)&#xD;
&#xD;
          -  Pregnancy, lactation&#xD;
&#xD;
          -  Any medical, psychological or other condition restricting the patient's ability to&#xD;
             provide informed consent&#xD;
&#xD;
          -  Participation in another clinical trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Bethanien Hospital, Clinic for Pneumology and Allergology, Center for Sleep and Respiratory Medicine</name>
      <address>
        <city>Solingen</city>
        <state>NRW</state>
        <zip>42699</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <reference>
    <citation>Ryu JH, Olson EJ, Midthun DE, Swensen SJ. Diagnostic approach to the patient with diffuse lung disease. Mayo Clin Proc. 2002 Nov;77(11):1221-7; quiz 1227. doi: 10.4065/77.11.1221.</citation>
    <PMID>12440558</PMID>
  </reference>
  <reference>
    <citation>Collard HR, King TE Jr. Demystifying idiopathic interstitial pneumonia. Arch Intern Med. 2003 Jan 13;163(1):17-29. doi: 10.1001/archinte.163.1.17.</citation>
    <PMID>12523913</PMID>
  </reference>
  <reference>
    <citation>King TE Jr. Clinical advances in the diagnosis and therapy of the interstitial lung diseases. Am J Respir Crit Care Med. 2005 Aug 1;172(3):268-79. doi: 10.1164/rccm.200503-483OE. Epub 2005 May 5.</citation>
    <PMID>15879420</PMID>
  </reference>
  <reference>
    <citation>Raghu G, Collard HR, Egan JJ, Martinez FJ, Behr J, Brown KK, Colby TV, Cordier JF, Flaherty KR, Lasky JA, Lynch DA, Ryu JH, Swigris JJ, Wells AU, Ancochea J, Bouros D, Carvalho C, Costabel U, Ebina M, Hansell DM, Johkoh T, Kim DS, King TE Jr, Kondoh Y, Myers J, Muller NL, Nicholson AG, Richeldi L, Selman M, Dudden RF, Griss BS, Protzko SL, Schunemann HJ; ATS/ERS/JRS/ALAT Committee on Idiopathic Pulmonary Fibrosis. An official ATS/ERS/JRS/ALAT statement: idiopathic pulmonary fibrosis: evidence-based guidelines for diagnosis and management. Am J Respir Crit Care Med. 2011 Mar 15;183(6):788-824. doi: 10.1164/rccm.2009-040GL.</citation>
    <PMID>21471066</PMID>
  </reference>
  <reference>
    <citation>Ferson PF, Landreneau RJ, Dowling RD, Hazelrigg SR, Ritter P, Nunchuck S, Perrino MK, Bowers CM, Mack MJ, Magee MJ. Comparison of open versus thoracoscopic lung biopsy for diffuse infiltrative pulmonary disease. J Thorac Cardiovasc Surg. 1993 Aug;106(2):194-9.</citation>
    <PMID>8341061</PMID>
  </reference>
  <reference>
    <citation>Miller JD, Urschel JD, Cox G, Olak J, Young JE, Kay JM, McDonald E. A randomized, controlled trial comparing thoracoscopy and limited thoracotomy for lung biopsy in interstitial lung disease. Ann Thorac Surg. 2000 Nov;70(5):1647-50. doi: 10.1016/s0003-4975(00)01913-5.</citation>
    <PMID>11093503</PMID>
  </reference>
  <reference>
    <citation>Ayed AK, Raghunathan R. Thoracoscopy versus open lung biopsy in the diagnosis of interstitial lung disease: a randomised controlled trial. J R Coll Surg Edinb. 2000 Jun;45(3):159-63.</citation>
    <PMID>10881481</PMID>
  </reference>
  <reference>
    <citation>Bensard DD, McIntyre RC Jr, Waring BJ, Simon JS. Comparison of video thoracoscopic lung biopsy to open lung biopsy in the diagnosis of interstitial lung disease. Chest. 1993 Mar;103(3):765-70. doi: 10.1378/chest.103.3.765.</citation>
    <PMID>8449066</PMID>
  </reference>
  <reference>
    <citation>Babiak A, Hetzel J, Krishna G, Fritz P, Moeller P, Balli T, Hetzel M. Transbronchial cryobiopsy: a new tool for lung biopsies. Respiration. 2009;78(2):203-8. doi: 10.1159/000203987. Epub 2009 Feb 21.</citation>
    <PMID>19246874</PMID>
  </reference>
  <reference>
    <citation>Pajares V, Torrego A, Puzo C, Lerma E, Gil De Bernabe MA, Franquet T. [Transbronchial lung biopsy using cryoprobes]. Arch Bronconeumol. 2010 Mar;46(3):111-5. doi: 10.1016/j.arbres.2009.09.012. Epub 2009 Nov 25. Spanish.</citation>
    <PMID>19939546</PMID>
  </reference>
  <reference>
    <citation>Aktas Z, Gunay E, Hoca NT, Yilmaz A, Demirag F, Gunay S, Sipit T, Kurt EB. Endobronchial cryobiopsy or forceps biopsy for lung cancer diagnosis. Ann Thorac Med. 2010 Oct;5(4):242-6. doi: 10.4103/1817-1737.69117.</citation>
    <PMID>20981186</PMID>
  </reference>
  <reference>
    <citation>Hetzel J, Eberhardt R, Herth FJ, Petermann C, Reichle G, Freitag L, Dobbertin I, Franke KJ, Stanzel F, Beyer T, Moller P, Fritz P, Ott G, Schnabel PA, Kastendieck H, Lang W, Morresi-Hauf AT, Szyrach MN, Muche R, Shah PL, Babiak A, Hetzel M. Cryobiopsy increases the diagnostic yield of endobronchial biopsy: a multicentre trial. Eur Respir J. 2012 Mar;39(3):685-90. doi: 10.1183/09031936.00033011. Epub 2011 Aug 18.</citation>
    <PMID>21852332</PMID>
  </reference>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>October 9, 2012</study_first_submitted>
  <study_first_submitted_qc>October 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 26, 2012</study_first_posted>
  <last_update_submitted>October 26, 2018</last_update_submitted>
  <last_update_submitted_qc>October 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 29, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Interstitial Lung Disease</keyword>
  <keyword>Diagnosis</keyword>
  <keyword>Cryobiopsy</keyword>
  <keyword>Video-assisted thoracic surgery</keyword>
  <keyword>Lung biopsy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Lung Diseases, Interstitial</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01714518
org study id: WI_KryoVATS_80/2012
nct id: NCT01714518
lead sponsor: 
has dmc: No
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.
observational model: Case-Only
time perspective: Prospective
measure: Rate of diagnostic cryobiopsies
time frame: up to 3 days
description: 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.
measure: Rate of complications during cryobiopsy
time frame: During and up to 48 hours after procedure
description: Number of complications associated with cryobiopsy, divided into three categories of severity: mild/moderate/severe
measure: Rate of complications during VATS
time frame: During and up to 10 days after procedure
description: Number of complications associated with VATS, divided into three categories of severity: mild/moderate/severe
arm group label: ILD diagnosis
description: Patients subjected to Cryobiopsy and/or VATS for diagnosis of interstitial lung disease
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Germany
citation: Ryu JH, Olson EJ, Midthun DE, Swensen SJ. Diagnostic approach to the patient with diffuse lung disease. Mayo Clin Proc. 2002 Nov;77(11):1221-7; quiz 1227. doi: 10.4065/77.11.1221.
PMID: 12440558
citation: Collard HR, King TE Jr. Demystifying idiopathic interstitial pneumonia. Arch Intern Med. 2003 Jan 13;163(1):17-29. doi: 10.1001/archinte.163.1.17.
PMID: 12523913
citation: King TE Jr. Clinical advances in the diagnosis and therapy of the interstitial lung diseases. Am J Respir Crit Care Med. 2005 Aug 1;172(3):268-79. doi: 10.1164/rccm.200503-483OE. Epub 2005 May 5.
PMID: 15879420
citation: Raghu G, Collard HR, Egan JJ, Martinez FJ, Behr J, Brown KK, Colby TV, Cordier JF, Flaherty KR, Lasky JA, Lynch DA, Ryu JH, Swigris JJ, Wells AU, Ancochea J, Bouros D, Carvalho C, Costabel U, Ebina M, Hansell DM, Johkoh T, Kim DS, King TE Jr, Kondoh Y, Myers J, Muller NL, Nicholson AG, Richeldi L, Selman M, Dudden RF, Griss BS, Protzko SL, Schunemann HJ; ATS/ERS/JRS/ALAT Committee on Idiopathic Pulmonary Fibrosis. An official ATS/ERS/JRS/ALAT statement: idiopathic pulmonary fibrosis: evidence-based guidelines for diagnosis and management. Am J Respir Crit Care Med. 2011 Mar 15;183(6):788-824. doi: 10.1164/rccm.2009-040GL.
PMID: 21471066
citation: Ferson PF, Landreneau RJ, Dowling RD, Hazelrigg SR, Ritter P, Nunchuck S, Perrino MK, Bowers CM, Mack MJ, Magee MJ. Comparison of open versus thoracoscopic lung biopsy for diffuse infiltrative pulmonary disease. J Thorac Cardiovasc Surg. 1993 Aug;106(2):194-9.
PMID: 8341061
citation: Miller JD, Urschel JD, Cox G, Olak J, Young JE, Kay JM, McDonald E. A randomized, controlled trial comparing thoracoscopy and limited thoracotomy for lung biopsy in interstitial lung disease. Ann Thorac Surg. 2000 Nov;70(5):1647-50. doi: 10.1016/s0003-4975(00)01913-5.
PMID: 11093503
citation: Ayed AK, Raghunathan R. Thoracoscopy versus open lung biopsy in the diagnosis of interstitial lung disease: a randomised controlled trial. J R Coll Surg Edinb. 2000 Jun;45(3):159-63.
PMID: 10881481
citation: Bensard DD, McIntyre RC Jr, Waring BJ, Simon JS. Comparison of video thoracoscopic lung biopsy to open lung biopsy in the diagnosis of interstitial lung disease. Chest. 1993 Mar;103(3):765-70. doi: 10.1378/chest.103.3.765.
PMID: 8449066
citation: Babiak A, Hetzel J, Krishna G, Fritz P, Moeller P, Balli T, Hetzel M. Transbronchial cryobiopsy: a new tool for lung biopsies. Respiration. 2009;78(2):203-8. doi: 10.1159/000203987. Epub 2009 Feb 21.
PMID: 19246874
citation: Pajares V, Torrego A, Puzo C, Lerma E, Gil De Bernabe MA, Franquet T. [Transbronchial lung biopsy using cryoprobes]. Arch Bronconeumol. 2010 Mar;46(3):111-5. doi: 10.1016/j.arbres.2009.09.012. Epub 2009 Nov 25. Spanish.
PMID: 19939546
citation: Aktas Z, Gunay E, Hoca NT, Yilmaz A, Demirag F, Gunay S, Sipit T, Kurt EB. Endobronchial cryobiopsy or forceps biopsy for lung cancer diagnosis. Ann Thorac Med. 2010 Oct;5(4):242-6. doi: 10.4103/1817-1737.69117.
PMID: 20981186
citation: Hetzel J, Eberhardt R, Herth FJ, Petermann C, Reichle G, Freitag L, Dobbertin I, Franke KJ, Stanzel F, Beyer T, Moller P, Fritz P, Ott G, Schnabel PA, Kastendieck H, Lang W, Morresi-Hauf AT, Szyrach MN, Muche R, Shah PL, Babiak A, Hetzel M. Cryobiopsy increases the diagnostic yield of endobronchial biopsy: a multicentre trial. Eur Respir J. 2012 Mar;39(3):685-90. doi: 10.1183/09031936.00033011. Epub 2011 Aug 18.
PMID: 21852332
responsible party type: Sponsor
mesh term: Lung Diseases
mesh term: Lung Diseases, Interstitial