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

NCT03596528 | Unknown

• 1 other identifier: HCB/2017/0900
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Diseases, Interstitial

Keywords

Interstitial lung disease, cryobiopsy, surgical biopsy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Lung biopsy

OTHER

Lung biopsy

Procedure: Lung biopsy

Interventions

Lung biopsy PROCEDURE

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.

Also known as: Cryobiopsy

Lung biopsy

Eligibility Criteria

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

You may qualify if:

• 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.
• years and older.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (1)

Hospital Clinic

Barcelona, Catalonia, 08036, Spain

RECRUITING

Related Publications (13)

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  PMID: 21471066 BACKGROUND

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  PMID: 23742884 BACKGROUND

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  PMID: 10647831 BACKGROUND

• 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. doi: 10.1164/ajrccm.161.2.ats3-00. No abstract available.

  PMID: 10673212 BACKGROUND

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  PMID: 28840020 BACKGROUND

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  PMID: 17670651 BACKGROUND

• 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. doi: 10.1164/ajrccm.157.4.9707039. No abstract available.

  PMID: 9563754 BACKGROUND

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  PMID: 23672718 BACKGROUND

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  PMID: 17218598 BACKGROUND

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  PMID: 19246874 BACKGROUND

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  PMID: 16685001 BACKGROUND

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  PMID: 14636495 RESULT

MeSH Terms

Conditions

Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Alejandra Libreros Niño, MD

CONTACT

+34628296229; LIBREROS@clinic.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 12, 2018
• First Posted: July 24, 2018
• Study Start: March 23, 2018
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: July 26, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)