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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

Tracking Information
First Submitted Date  ICMJE February 5, 2010
First Posted Date  ICMJE February 8, 2010
Last Update Posted Date January 23, 2013
Study Start Date  ICMJE June 2011
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 5, 2010)
To analyze the histological quality and immunohistochemical findings of samples obtained by cryoprobe compared with TBLB obtained by conventional forceps. [ Time Frame: 3 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE "Diagnostic Yield and Safety of Transbronchial Lung Biopsy Using Cryoprobes Versus Conventional Forceps.
Official Title  ICMJE "Diagnostic Yield and Safety of Transbronchial Lung Biopsy Using Cryoprobes Versus Conventional Forceps:a Randomized Clinical Trial"
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Interstitial Lung Disease
Intervention  ICMJE
  • Procedure: Biopsy by cryoprobes
    Transbronchial lung biopsy with cryoprobes.
  • Procedure: Biopsy with conventional forceps
    Transbronchial lung biopsy with conventional forceps.
Study Arms  ICMJE
  • Active Comparator: 2. Biopsy with cryoprobes
    Transbronchial cryobiopsy with a cryoprobe.
    Intervention: Procedure: Biopsy by cryoprobes
  • Active Comparator: 2.Biopsy with forceps
    Transbronchial lung biopsy with conventional forceps.
    Intervention: Procedure: Biopsy with conventional forceps
Publications * Pajares V, Puzo C, Castillo D, Lerma E, Montero MA, Ramos-Barbón D, Amor-Carro O, Gil de Bernabé 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 21, 2013)
75
Original Estimated Enrollment  ICMJE
 (submitted: February 5, 2010)
80
Actual Study Completion Date  ICMJE September 2012
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with Interstitial Lung disease.

Exclusion Criteria:

  • Respiratory failure,haemodynamic instability, haemoptysis.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01064609
Other Study ID Numbers  ICMJE 2008-003232-38
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study Sponsor  ICMJE Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Verification Date June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP