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 Pau

Status: Completed

Conditions: Lung Diseases, Interstitial

Treatments: Procedure: Transbronchial lung biopsy.

Study type: Interventional

Funder types: Other

Identifiers

NCT02464592

IIBSP-CRI-2014-05

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

120 participants in 2 patient groups

Biopsy with Cryoprobes

Active Comparator group

Description:

Transbronchial lung biopsy with a cryoprobe.

Treatment:

Procedure: Transbronchial lung biopsy.

Biopsy with Conventional Forceps

Active Comparator group

Description:

Transbronchial lung biopsy with conventional forceps.

Treatment:

Procedure: Transbronchial lung biopsy.