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

Sponsor

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

Overall Status

Completed

CT.gov ID

NCT02464592

Collaborator

Hospital Universitario La Fe (Other), Germans Trias i Pujol Hospital (Other), Hospital General Universitario Santa Lucía (Other), Hospital Universitari de Bellvitge (Other), Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz (Other), Complejo Hospitalario Universitario de Vigo (Other), University of Salamanca (Other), Hospital Universitario de Valladolid (Other)

120

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Diseases, Interstitial	Procedure: Transbronchial lung biopsy.	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Apr 1, 2014

Actual Primary Completion Date :

Aug 1, 2017

Actual Study Completion Date :

Aug 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Biopsy with Cryoprobes Transbronchial lung biopsy with a cryoprobe.	Procedure: Transbronchial lung biopsy. Transbronchial lung biopsy with cryoprobe and with conventional forceps.
Active Comparator: Biopsy with Conventional Forceps Transbronchial lung biopsy with conventional forceps.	Procedure: Transbronchial lung biopsy. Transbronchial lung biopsy with cryoprobe and with conventional forceps.

Arm

Intervention/Treatment

Active Comparator: Biopsy with Cryoprobes

Transbronchial lung biopsy with a cryoprobe.

Procedure: Transbronchial lung biopsy.

Transbronchial lung biopsy with cryoprobe and with conventional forceps.

Active Comparator: Biopsy with Conventional Forceps

Transbronchial lung biopsy with conventional forceps.

Procedure: Transbronchial lung biopsy.

Transbronchial lung biopsy with cryoprobe and with conventional forceps.

Outcome Measures

Primary Outcome Measures

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

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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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.