Cryobiopsy vs. VATS in Diagnosis of Interstitial Lung Diseases

NCT01714518 | Completed

• 1 other identifier: WI_KryoVATS_80/2012
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Interstitial Lung Disease

Keywords

Interstitial Lung Disease; Diagnosis; Cryobiopsy; Video-assisted thoracic surgery; Lung biopsy

Outcome Measures

Primary Outcomes (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.

  up to 3 days

Secondary Outcomes (2)

• Rate of complications during cryobiopsy

  During and up to 48 hours after procedure

• Rate of complications during VATS

  During and up to 10 days after procedure

Study Arms (1)

ILD diagnosis

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Inpatients undergoing routine diagnosis of known or suspected interstitial lung disease

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wissenschaftliches Institut Bethanien e.V: lead

Study Sites (1)

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

Solingen, North Rhine-Westphalia, 42699, Germany

Location

Related Publications (14)

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• 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.

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  PMID: 21471066 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 30852561 DERIVED

• 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.

  PMID: 27055830 DERIVED

MeSH Terms

Conditions

Lung Diseases, Interstitial; Disease

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2012
• First Posted: October 26, 2012
• Study Start: October 16, 2012
• Primary Completion: June 30, 2017
• Study Completion: June 30, 2017
• Last Updated: October 29, 2018

Record last verified: 2018-10

Locations

DE (1)