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"Diagnostic Yield and Safety of Transbronchial Lung Biopsy Using Cryoprobes Versus Conventional Forceps.

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ClinicalTrials.gov Identifier: NCT01064609
Recruitment Status : Completed
First Posted : February 8, 2010
Last Update Posted : January 23, 2013
Sponsor:
Information provided by (Responsible Party):
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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.

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.


Condition or disease Intervention/treatment Phase
Interstitial Lung Disease Procedure: Biopsy by cryoprobes Procedure: Biopsy with conventional forceps Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: "Diagnostic Yield and Safety of Transbronchial Lung Biopsy Using Cryoprobes Versus Conventional Forceps:a Randomized Clinical Trial"
Study Start Date : June 2011
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 2. Biopsy with cryoprobes
Transbronchial cryobiopsy with a cryoprobe.
Procedure: Biopsy by cryoprobes
Transbronchial lung biopsy with cryoprobes.
Active Comparator: 2.Biopsy with forceps
Transbronchial lung biopsy with conventional forceps.
Procedure: Biopsy with conventional forceps
Transbronchial lung biopsy with conventional forceps.



Primary Outcome Measures :
  1. To analyze the histological quality and immunohistochemical findings of samples obtained by cryoprobe compared with TBLB obtained by conventional forceps. [ Time Frame: 3 years ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with Interstitial Lung disease.

Exclusion Criteria:

  • Respiratory failure,haemodynamic instability, haemoptysis.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01064609


Locations
Spain
Hospital de la Sanrta Creu i Sant Pau
Barcelona, Spain, 08024
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Investigators
Principal Investigator: Virginia Pajares, Doctor Hospital del Santa Creu i Sant Pau
Principal Investigator: Alfons Torrego, Doctor Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Principal Investigator: Mª Carmen Puzo, Doctor Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier: NCT01064609     History of Changes
Other Study ID Numbers: 2008-003232-38
First Posted: February 8, 2010    Key Record Dates
Last Update Posted: January 23, 2013
Last Verified: June 2011

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Interstitial
Respiratory Tract Diseases