AzTrials
AzTrials

Interstitial Lung DiseaseNCT01714518

Cryobiopsy vs. VATS in Diagnosis of Interstitial Lung Diseases

An observational study of Interstitial Lung Disease, run by Wissenschaftliches Institut Bethanien e.V at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Interstitial Lung Disease
How many people
62 participants
Where
1 siteGermany
Study dates
16 Oct 2012to 30 Jun 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Inpatients undergoing routine diagnosis of known or suspected interstitial lung disease

Who may be able to join

  • Age ≥ 18 years
  • Known or newly diagnosed interstitial lung disease (ILD)
  • Indication for lung biopsy for definitive ILD diagnosis
  • Informed Consent provided

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Bethanien Hospital, Clinic for Pneumology and Allergology, Center for Sleep and Respiratory Medicine

    Solingen, North Rhine-Westphalia, 42699

Other trials in Germany

About this study

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

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.

Keywords
Interstitial Lung Disease, Diagnosis, Cryobiopsy, Video-assisted thoracic surgery, Lung biopsy
Medical subject headings
Lung Diseases, Interstitial, Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01714518
Study groupRoleWhat they receive
ILD diagnosisPatients subjected to Cryobiopsy and/or VATS for diagnosis of interstitial lung disease

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of diagnostic cryobiopsies

    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.

    Measured: up to 3 days

Secondary outcomes (2)

  1. Rate of complications during cryobiopsy

    Number of complications associated with cryobiopsy, divided into three categories of severity: mild/moderate/severe

    Measured: During and up to 48 hours after procedure

  2. Rate of complications during VATS

    Number of complications associated with VATS, divided into three categories of severity: mild/moderate/severe

    Measured: During and up to 10 days after procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2012 (estimated)
  2. Study start16 Oct 2012
  3. Primary completion30 Jun 2017
  4. Study completion30 Jun 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01714518
Sponsor's protocol ID
WI_KryoVATS_80/2012
Status last verified
Oct 2018
First submitted
9 Oct 2012
Last updated
29 Oct 2018
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 12440558

  • 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.

    PubMed 12523913

  • 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.

    PubMed 15879420

  • 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.

    PubMed 21471066

  • 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.

    PubMed 8341061

  • 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.

    PubMed 11093503

  • 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.

    PubMed 10881481

  • 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.

    PubMed 8449066

  • 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.

    PubMed 19246874

  • 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.

    PubMed 19939546

  • 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.

    PubMed 20981186

  • 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.

    PubMed 21852332

  • Hagmeyer L, Theegarten D, Wohlschlager J, Hager T, Treml M, Herkenrath SD, Hekmat K, Heldwein M, Randerath WJ. Transbronchial cryobiopsy in fibrosing interstitial lung disease: modifications of the procedure lead to risk reduction. Thorax. 2019 Jul;74(7):711-714. doi: 10.1136/thoraxjnl-2018-212095. Epub 2019 Mar 9.

    PubMed 30852561

  • Hagmeyer L, Theegarten D, Treml M, Priegnitz C, Randerath W. Validation of transbronchial cryobiopsy in interstitial lung disease - interim analysis of a prospective trial and critical review of the literature. Sarcoidosis Vasc Diffuse Lung Dis. 2016 Mar 29;33(1):2-9.

    PubMed 27055830

Questions about this trial

What is this clinical trial studying?

An observational study of Interstitial Lung Disease, run by Wissenschaftliches Institut Bethanien e.V at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of diagnostic cryobiopsies (time frame: up to 3 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01714518, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in