"Diagnostic Yield and Safety of Transbronchial Lung Biopsy Using Cryoprobes Versus Conventional Forceps.
NCT ID: NCT01064609
Last Updated: 2013-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
75 participants
INTERVENTIONAL
2011-06-30
2012-09-30
Brief Summary
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Objectives:To 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 Masson's 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 transport.The specifical monoclonal antibodies will be used for immunohistochemical analysis.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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2. Biopsy with cryoprobes
Transbronchial cryobiopsy with a cryoprobe.
Biopsy by cryoprobes
Transbronchial lung biopsy with cryoprobes.
2.Biopsy with forceps
Transbronchial lung biopsy with conventional forceps.
Biopsy with conventional forceps
Transbronchial lung biopsy with conventional forceps.
Interventions
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Biopsy by cryoprobes
Transbronchial lung biopsy with cryoprobes.
Biopsy with conventional forceps
Transbronchial lung biopsy with conventional forceps.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
80 Years
ALL
No
Sponsors
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Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
OTHER
Responsible Party
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Principal Investigators
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Virginia Pajares, Doctor
Role: PRINCIPAL_INVESTIGATOR
Hospital del Santa Creu i Sant Pau
Alfons Torrego, Doctor
Role: PRINCIPAL_INVESTIGATOR
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Mª Carmen Puzo, Doctor
Role: PRINCIPAL_INVESTIGATOR
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Locations
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Hospital de la Sanrta Creu i Sant Pau
Barcelona, Barcelona, Spain
Countries
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References
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Pajares V, Puzo C, Castillo D, Lerma E, Montero MA, Ramos-Barbon D, Amor-Carro O, Gil de Bernabe A, Franquet T, Plaza V, Hetzel J, Sanchis J, Torrego A. Diagnostic yield of transbronchial cryobiopsy in interstitial lung disease: a randomized trial. Respirology. 2014 Aug;19(6):900-6. doi: 10.1111/resp.12322. Epub 2014 Jun 1.
Other Identifiers
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2008-003232-38
Identifier Type: -
Identifier Source: org_study_id
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