Diagnostic Yield and Safety of Transbronchial Lung Biopsy Using Cryoprobes Versus Conventional Forceps. A Multicenter Study

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the diagnostic yield and safety of transbronchial lung biopsies (TBLB) with cryoprobe versus conventional forceps in patients with diffuse lung disease.

Official Title
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Diagnostic Yield and Safety of Transbronchial Lung Biopsy Using Cryoprobes Versus Conventional Forceps. A Multicenter Study

Conditions
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Lung Diseases, Interstitial

Intervention / Treatment
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* Procedure: Transbronchial lung biopsy.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >18 years old Patients with diffuse lung disease candidate to study with transbronchial lung biopsy (TBLB). Inform consent signed. Exclusion Criteria: FEV1 <40% of reference value. Respiratory insufficiency (pO2 <60 mmHg or pCO2 >45 mmHg). Use of anticoagulant therapy or presence of a coagulation (disorder abnormal platelets counts, international normalized ratio > 1.5). Bullous emphysema. Pulmonary arterial hypertension. Hypersensitivity to anaesthetic and sedative drugs (lidocaine, midazolam, propofol, remifentanyl). Psychiatric illness. Comorbidities that could increase the risk of the TBLB. Pregnancy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Biopsy with Cryoprobes<br>Transbronchial lung biopsy with a cryoprobe. | Procedure: Transbronchial lung biopsy.<br>* Transbronchial lung biopsy with cryoprobe and with conventional forceps.<br>|
| Active Comparator: Biopsy with Conventional Forceps<br>Transbronchial lung biopsy with conventional forceps. | Procedure: Transbronchial lung biopsy.<br>* Transbronchial lung biopsy with cryoprobe and with conventional forceps.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic yield of transbronchial lung biopsy (TBLB) | Comparing those TBLB obtained by cryoprobes versus conventional forceps (number of diagnosis with each technique). | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histological quality of samples as defined the presence of alveolar units in each sample. Composite measure. | The quality of samples are defined by the size, presence of artifacts and presence of alveolar units in each sample. | 24 months | 
| Safety related to the procedure of the TBLB obtained by cryoprobe compared with conventional forceps assessed by chest radiography. | Chest radiography after TBLB. | 24 months | 
| Safety related to the procedure of the TBLB obtained by cryoprobe compared with conventional forceps assessed by control of bleeding. | Control of bleeding during procedure. | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cryoprobes, Transbronchial lung biopsy, Cryobiopsy