Ignite Creation Date:
2024-05-05 @ 10:16 PM
Last Modification Date:
2024-10-26 @ 10:16 AM
Study NCT ID:
NCT01064609
Status:
COMPLETED
Last Update Posted:
2013-01-23
First Post:
2010-02-05
Brief Title:
Diagnostic Yield and Safety of Transbronchial Lung Biopsy Using Cryoprobes Versus Conventional Forceps
Sponsor:
Fundació Institut de Recerca de lHospital de la Santa Creu i Sant Pau
Organization:
Fundació Institut de Recerca de lHospital de la Santa Creu i Sant Pau
Study Overview
Official Title:
Diagnostic Yield and Safety of Transbronchial Lung Biopsy Using Cryoprobes Versus Conventional Forcepsa Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2011-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Transbronchial lung biopsy TBLB is a bronchoscopic procedure used to obtain peripheral lung tissue Small size and artefacts cause variable and usually poor diagnostic yield The use of cryoprobes may allow for larger size and better quality biopsy samples
ObjectivesTo analyze the histological quality and immunohistochemical findings of samples obtained by cryoprobe compared with TBLB obtained by conventional forceps and to assess the safety and complications of TBLB with cryoprobe versus the conventional method
Methodology
Prospective randomized study of 80 patients The transbronchial lung biopsy was indicated for diagnoses of a interstitial lung disease In both procedures the videobroncoscopy used will be a Olympus 260-T
The transbronchial lung biopsy will be carried out with conventional forceps Boston Biopsy Forceps Ref 1556 and Olympus FB-19E and cryoprobe Erbokryo AC TBLB will be performed by fluoroscopy guided and the cryoprobe or forceps will place in an area of the peripheral lung previously selected according to CT findings Lung biopsies will be processed The samples submitted for histological analysis will be fixed in formalin and embedded in paraffin Staining will perform with hematoxylin-eosin and Massons trichrome and the samples will be analyzed by a pathologist according to a protocol The samples submitted to immunohistochemical study will be frozen liquid nitrogen for later transportThe specifical monoclonal antibodies will be used for immunohistochemical analysis
ObjectivesTo analyze the histological quality and immunohistochemical findings of samples obtained by cryoprobe compared with TBLB obtained by conventional forceps and to assess the safety and complications of TBLB with cryoprobe versus the conventional method
Methodology
Prospective randomized study of 80 patients The transbronchial lung biopsy was indicated for diagnoses of a interstitial lung disease In both procedures the videobroncoscopy used will be a Olympus 260-T
The transbronchial lung biopsy will be carried out with conventional forceps Boston Biopsy Forceps Ref 1556 and Olympus FB-19E and cryoprobe Erbokryo AC TBLB will be performed by fluoroscopy guided and the cryoprobe or forceps will place in an area of the peripheral lung previously selected according to CT findings Lung biopsies will be processed The samples submitted for histological analysis will be fixed in formalin and embedded in paraffin Staining will perform with hematoxylin-eosin and Massons trichrome and the samples will be analyzed by a pathologist according to a protocol The samples submitted to immunohistochemical study will be frozen liquid nitrogen for later transportThe specifical monoclonal antibodies will be used for immunohistochemical analysis
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None