"Diagnostic Yield and Safety of Transbronchial Lung Biopsy Using Cryoprobes Versus Conventional Forceps.
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention |
|---|---|
|
Interstitial Lung Disease |
Procedure: Biopsy by cryoprobes Procedure: Biopsy with conventional forceps |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | "Diagnostic Yield and Safety of Transbronchial Lung Biopsy Using Cryoprobes Versus Conventional Forceps:a Randomized Clinical Trial" |
- To analyze the histological quality and immunohistochemical findings of samples obtained by cryoprobe compared with TBLB obtained by conventional forceps. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
| Enrollment: | 75 |
| Study Start Date: | June 2011 |
| Study Completion Date: | September 2012 |
| Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with Interstitial Lung disease.
Exclusion Criteria:
- Respiratory failure,haemodynamic instability, haemoptysis.
Contacts and Locations| Spain | |
| Hospital de la Sanrta Creu i Sant Pau | |
| Barcelona, Spain, 08024 | |
| 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 |
More Information
No publications provided
| 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 |
| Study First Received: | February 5, 2010 |
| Last Updated: | January 21, 2013 |
| Health Authority: | Spain: Ethics Committee |
Additional relevant MeSH terms:
|
Lung Diseases Pulmonary Fibrosis Lung Diseases, Interstitial Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 22, 2013