Back to results"Diagnostic Yield and Safety of Transbronchial Lung Biopsy Using Cryoprobes Versus Conventional Forceps.
Primary Purpose
Interstitial Lung Disease
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Biopsy by cryoprobes
Biopsy with conventional forceps
Sponsored by
About this trial
This is an interventional diagnostic trial for Interstitial Lung Disease
Eligibility Criteria
Inclusion Criteria:
- Patients with Interstitial Lung disease.
Exclusion Criteria:
- Respiratory failure,haemodynamic instability, haemoptysis.
Sites / Locations
- Hospital de la Sanrta Creu i Sant Pau
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
2. Biopsy with cryoprobes
2.Biopsy with forceps
Arm Description
Transbronchial cryobiopsy with a cryoprobe.
Transbronchial lung biopsy with conventional forceps.
Outcomes
Primary Outcome Measures
To analyze the histological quality and immunohistochemical findings of samples obtained by cryoprobe compared with TBLB obtained by conventional forceps.
Secondary Outcome Measures
Full Information
NCT ID
NCT01064609
First Posted
February 5, 2010
Last Updated
January 21, 2013
Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
1. Study Identification
Unique Protocol Identification Number
NCT01064609
Brief Title
"Diagnostic Yield and Safety of Transbronchial Lung Biopsy Using Cryoprobes Versus Conventional Forceps.
Official Title
"Diagnostic Yield and Safety of Transbronchial Lung Biopsy Using Cryoprobes Versus Conventional Forceps:a Randomized Clinical Trial"
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interstitial Lung Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2. Biopsy with cryoprobes
Arm Type
Active Comparator
Arm Description
Transbronchial cryobiopsy with a cryoprobe.
Arm Title
2.Biopsy with forceps
Arm Type
Active Comparator
Arm Description
Transbronchial lung biopsy with conventional forceps.
Intervention Type
Procedure
Intervention Name(s)
Biopsy by cryoprobes
Intervention Description
Transbronchial lung biopsy with cryoprobes.
Intervention Type
Procedure
Intervention Name(s)
Biopsy with conventional forceps
Intervention Description
Transbronchial lung biopsy with conventional forceps.
Primary Outcome Measure Information:
Title
To analyze the histological quality and immunohistochemical findings of samples obtained by cryoprobe compared with TBLB obtained by conventional forceps.
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with Interstitial Lung disease.
Exclusion Criteria:
Respiratory failure,haemodynamic instability, haemoptysis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Virginia Pajares, Doctor
Organizational Affiliation
Hospital del Santa Creu i Sant Pau
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alfons Torrego, Doctor
Organizational Affiliation
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mª Carmen Puzo, Doctor
Organizational Affiliation
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de la Sanrta Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08024
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
24890124
Citation
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.
Results Reference
derived
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"Diagnostic Yield and Safety of Transbronchial Lung Biopsy Using Cryoprobes Versus Conventional Forceps.
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