Interstitial Lung Disease (ILD). Comparative Study of the Diagnostic Yield of Surgical Lung Biopsy Versus Cryobiopsy.
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Hospital Clinic of Barcelona
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Quality of the tissue sample reported by the pathologist.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Lung biopsy
Lung biopsy
Intervention: Lung biopsy (Procedure)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Alejandra Libreros Niño
MD
Hospital Clinic of Barcelona