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

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ClinicalTrials.gov Identifier: NCT03596528
Recruitment Status : Unknown
Verified July 2018 by Alejandra Libreros Niño, Hospital Clinic of Barcelona.
Recruitment status was:  Recruiting
First Posted : July 24, 2018
Last Update Posted : July 26, 2018
Sponsor:
Information provided by (Responsible Party):
Alejandra Libreros Niño, Hospital Clinic of Barcelona

Study Description
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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.


Condition or disease Intervention/treatment Phase
Lung Diseases, Interstitial Procedure: Lung biopsy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Interstitial Lung Disease (ILD). Comparative Study of the Diagnostic Yield of Surgical Lung Biopsy Versus Cryobiopsy.
Actual Study Start Date : March 23, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Lung biopsy
Lung biopsy
 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.
Other Name: Cryobiopsy


Outcome Measures
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Primary Outcome Measures :
  1. Quality of the tissue sample reported by the pathologist. [ Time Frame: for statistical analysis, 12 months after the first inclusion ]
    comparison of diagnostic yield of cryobiopsy versus surgical lung biopsy according to the quality of the tissue sample reported by the pathologist.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03596528


Contacts
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Contact: Alejandra Libreros Niño, MD +34628296229 LIBREROS@clinic.cat

Locations
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Spain
Hospital Clinic Recruiting
Barcelona, Cataluña, Spain, 08036
Contact: Alejandra Libreros Niño, M.D.    +34628296229    LIBREROS@clinic.cat   
Contact: Alejandra Libreros Niño    +34628296229    LIBREROS@clinic.cat   
Sponsors and Collaborators
Hospital Clinic of Barcelona
More Information
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Publications of Results:

Other Publications:

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Responsible Party: Alejandra Libreros Niño, MD, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT03596528    
Other Study ID Numbers: HCB/2017/0900
First Posted: July 24, 2018    Key Record Dates
Last Update Posted: July 26, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alejandra Libreros Niño, Hospital Clinic of Barcelona:
Interstitial lung disease, cryobiopsy, surgical biopsy
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Interstitial
Respiratory Tract Diseases