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

Not Applicable

Completed

• Conditions: Lung Diseases, Interstitial

• 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

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2015-05-06
• Study First Submitted QC: 2015-06-03
• Study First Posted: 2015-06-08
• Primary Completion: 2017-08
• Study Completion: 2017-08
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-27
• Last Update Posted: 2017-09-29

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

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