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

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau1 site in 1 country120 target enrollmentApril 2014

ConditionsLung Diseases, Interstitial

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Lung Diseases, Interstitial
Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Enrollment: 120
Locations: 1
Primary Endpoint: Diagnostic yield of transbronchial lung biopsy (TBLB)
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 2014

End Date

August 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Diagnostic yield of transbronchial lung biopsy (TBLB)

Time Frame: 24 months

Comparing those TBLB obtained by cryoprobes versus conventional forceps (number of diagnosis with each technique).

Secondary Outcomes

Safety related to the procedure of the TBLB obtained by cryoprobe compared with conventional forceps assessed by control of bleeding.(24 months)
Histological quality of samples as defined the presence of alveolar units in each sample. Composite measure.(24 months)
Safety related to the procedure of the TBLB obtained by cryoprobe compared with conventional forceps assessed by chest radiography.(24 months)