Diagnostic Yield and Safety of Transbronchial Lung Biopsy Using Cryoprobes Versus Conventional Forceps. A Multicenter Study
Not Applicable
Completed
- Conditions
- Lung Diseases, Interstitial
- Interventions
- Procedure: Transbronchial lung biopsy.
- Registration Number
- NCT02464592
- Lead Sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Biopsy with Cryoprobes Transbronchial lung biopsy. Transbronchial lung biopsy with a cryoprobe. Biopsy with Conventional Forceps Transbronchial lung biopsy. Transbronchial lung biopsy with conventional forceps.
- Primary Outcome Measures
Name Time Method Diagnostic yield of transbronchial lung biopsy (TBLB) 24 months Comparing those TBLB obtained by cryoprobes versus conventional forceps (number of diagnosis with each technique).
- Secondary Outcome Measures
Name Time Method Safety related to the procedure of the TBLB obtained by cryoprobe compared with conventional forceps assessed by control of bleeding. 24 months Control of bleeding during procedure.
Histological quality of samples as defined the presence of alveolar units in each sample. Composite measure. 24 months The quality of samples are defined by the size, presence of artifacts and presence of alveolar units in each sample.
Safety related to the procedure of the TBLB obtained by cryoprobe compared with conventional forceps assessed by chest radiography. 24 months Chest radiography after TBLB.
Trial Locations
- Locations (1)
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain