Cryobiopsy vs. VATS in Diagnosis of Interstitial Lung Diseases

NCT ID: NCT01714518

Last Updated: 2018-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

62 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-16

Study Completion Date

2017-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Interstitial Lung Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ILD diagnosis

Patients subjected to Cryobiopsy and/or VATS for diagnosis of interstitial lung disease

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Wissenschaftliches Institut Bethanien e.V

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Solingen, North Rhine-Westphalia, Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 12440558 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12523913 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15879420 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21471066 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8341061 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11093503 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10881481 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8449066 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19246874 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19939546 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20981186 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21852332 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30852561 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27055830 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

WI_KryoVATS_80/2012

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.