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 Pau120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

120

Conditions

Lung Diseases, Interstitial

Interventions

Transbronchial lung biopsy.PROCEDURE

Transbronchial lung biopsy with cryoprobe and with conventional forceps.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Outcomes

Primary Outcomes

Diagnostic yield of transbronchial lung biopsy (TBLB)

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

Time frame: 24 months

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 24 months

Data from ClinicalTrials.gov

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