Interstitial Lung Disease (ILD). Diagnostic Yield of Surgical Lung Biopsy Versus Cryobiopsy in the Same Surgical Stage.

Lung Diseases, Interstitial Clinical Trial

Official title:

Interstitial Lung Disease (ILD). Comparative Study of the Diagnostic Yield of Surgical Lung Biopsy Versus Cryobiopsy.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03596528
• Other study ID #: HCB/2017/0900
• Status: Recruiting
• Phase: N/A
• Start date: March 23, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: July 2018
• Source: Hospital Clinic of Barcelona
• Contact: Alejandra Libreros Niño, MD
• Phone: +34628296229
• Email: LIBREROS[@]clinic.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In patients with interstitial lung disease (ILD) with inconsistent clinical and radiological features, establishing a reliable diagnosis of ILD requires a surgical lung biopsy

Transbronchial cryobiopsy is a minimally invasive, rapid, safe technique, and with histologic diagnostic yields, for ILD, typically exceeding 70 -80% .

The aim of this study is to compare and analyze the diagnostic yield, for ILD, and complications following SLB and TC

Methods. The investigators designed a descriptive, comparative and cross-sectional study in patients with ILD, in which SLB and CT will be performed in the same surgical stage, as diagnostic tests.

This study will be conducted from January 2018 to January 2019. Surgical lung biopsy and TC will be performed in the same surgical stage in all patients, under general anesthesia and mechanical ventilation. First TC will be performed by a pulmonologist, sequentially a thoracic surgeon will carry out a SLB.

The samples obtained will be analyzed by different pathologist to compare both techniques in terms of histologic features.

Diagnostic yield, postoperative complications, comorbidities and lenght of stay will be analyzed and compared following these procedures.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients for suspected ILD eligible for lung biopsy reviewed during multidisciplinary approach.

• Subject provides informed consent.

• A negative pregnancy test in women of child-bearing potential.

• Subject is mentally capable of understanding study procedures.

• 18 years and older.

Exclusion Criteria:

• Study subject has any disease or condition that interferes with safe completion of the study including:

• Platelet count < 50,000 or Coagulopathy defined as an International Normalized Ratio (INR) > 1.5 on the day of procedure, as well as discontinuation of ticagrelor or clopidogrel within 5 days of procedure.

• Severely impaired lung function as determined with spirometry evidenced by a forced expiratory volume in 1 second (FEV1) < 0.8, or radiographically as diffuse bullous disease

• Hemodynamic instability with systolic blood pressure <90 mmHg or heart rate > 120 beats/min, unless deemed to be stable with these values by the surgical or interventional pulmonary attending physicians

• Hypoxemia with pulse oximetry values <88% or partial pressure of oxygen in arterial blood (PaO2) < 60 on baseline oxygen requirements

• Concurrent participation in another study involving investigational drugs or investigational medical devices

• Inability to read and understand the necessary study documents

Related Conditions & MeSH terms

• Lung Diseases
• Lung Diseases, Interstitial

Intervention

Procedure:
• Lung biopsy
Each patient will be brought to the operating room and will undergo cryobiopsy and surgical biopsy of the lung sequentially in the same surgical stage.

Locations

Country	Name	City	State
Spain	Hospital Clinic	Barcelona	Cataluña

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

References & Publications (13)

American Thoracic Society. Idiopathic pulmonary fibrosis: diagnosis and treatment. International consensus statement. American Thoracic Society (ATS), and the European Respiratory Society (ERS). Am J Respir Crit Care Med. 2000 Feb;161(2 Pt 1):646-64. Review. — View 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. — View Citation

Berbescu EA, Katzenstein AL, Snow JL, Zisman DA. Transbronchial biopsy in usual interstitial pneumonia. Chest. 2006 May;129(5):1126-31. — View Citation

Fibla JJ, Molins L, Simon C, Pérez J, Vidal G. Early removal of chest drainage after videothoracoscopic lung biopsy. Interact Cardiovasc Thorac Surg. 2006 Oct;5(5):581-3. Epub 2006 Jun 28. — View Citation

Hodnett PA, Naidich DP. Fibrosing interstitial lung disease. A practical high-resolution computed tomography-based approach to diagnosis and management and a review of the literature. Am J Respir Crit Care Med. 2013 Jul 15;188(2):141-9. doi: 10.1164/rccm.201208-1544CI. Review. — View Citation

Katzenstein AL, Myers JL. Idiopathic pulmonary fibrosis: clinical relevance of pathologic classification. Am J Respir Crit Care Med. 1998 Apr;157(4 Pt 1):1301-15. Review. — View Citation

Lentz RJ, Argento AC, Colby TV, Rickman OB, Maldonado F. Transbronchial cryobiopsy for diffuse parenchymal lung disease: a state-of-the-art review of procedural techniques, current evidence, and future challenges. J Thorac Dis. 2017 Jul;9(7):2186-2203. doi: 10.21037/jtd.2017.06.96. Review. — View 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, Müller NL, Nicholson AG, Richeldi L, Selman M, Dudden RF, Griss BS, Protzko SL, Schünemann 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. — View Citation

Rena O, Casadio C, Leo F, Giobbe R, Cianci R, Baldi S, Rapellino M, Maggi G. Videothoracoscopic lung biopsy in the diagnosis of interstitial lung disease. Eur J Cardiothorac Surg. 1999 Dec;16(6):624-7. — View Citation

Shorr AF, Lettieri CJ, Helman DL. Role for transbronchial biopsy in the diagnosis of usual interstitial pneumonia. Chest. 2007 Jan;131(1):329-30; author reply 330. — View Citation

Walker CM, Chung JH, Wall C, Pipavath SN, Chapman T, Reddy GP, Stern EJ, Godwin JD, Weinberger E. Interactive high-resolution computed tomography digital atlas of interstitial lung disease. Acad Radiol. 2011 Nov;18(11):1453-60. doi: 10.1016/j.acra.2011.07.008. Epub 2011 Sep 1. — View Citation

Xaubet A, Ancochea J, Blanquer R, Montero C, Morell F, Rodríguez Becerra E, Sueiro A, Villena V; Grupo de Investigación en Enfermedades Pulmonares Intersticiales Difusas. Area de Técnicas y Transplante. SEPAR. [Diagnosis and treatment of diffuse interstit — View Citation

Xaubet A, Ancochea J, Bollo E, Fernández-Fabrellas E, Franquet T, Molina-Molina M, Montero MA, Serrano-Mollar A; Sociedad Española de Neumología y Cirugía Torácica (SEPAR) Research Group on Diffuse Pulmonary Diseases. Guidelines for the diagnosis and treatment of idiopathic pulmonary fibrosis. Sociedad Española de Neumología y Cirugía Torácica (SEPAR) Research Group on Diffuse Pulmonary Diseases. Arch Bronconeumol. 2013 Aug;49(8):343-53. doi: 10.1016/j.arbres.2013.03.011. Epub 2013 Jun 4. English, Spanish. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of the tissue sample reported by the pathologist.	comparison of diagnostic yield of cryobiopsy versus surgical lung biopsy according to the quality of the tissue sample reported by the pathologist.	for statistical analysis, 12 months after the first inclusion