NCT01064609

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 8, 2010

Completed
1.3 years until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

January 23, 2013

Status Verified

June 1, 2011

Enrollment Period

1.3 years

First QC Date

February 5, 2010

Last Update Submit

January 21, 2013

Conditions

Interstitial Lung Disease

Outcome Measures

Primary Outcomes (1)

  • To analyze the histological quality and immunohistochemical findings of samples obtained by cryoprobe compared with TBLB obtained by conventional forceps.

    3 years

Study Arms (2)

2. Biopsy with cryoprobes

ACTIVE COMPARATOR

Transbronchial cryobiopsy with a cryoprobe.

Procedure: Biopsy by cryoprobes

2.Biopsy with forceps

ACTIVE COMPARATOR

Transbronchial lung biopsy with conventional forceps.

Procedure: Biopsy with conventional forceps

Interventions

Biopsy by cryoprobesPROCEDURE

Transbronchial lung biopsy with cryoprobes.

2. Biopsy with cryoprobes
Biopsy with conventional forcepsPROCEDURE

Transbronchial lung biopsy with conventional forceps.

2.Biopsy with forceps

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with Interstitial Lung disease.

You may not qualify if:

  • Respiratory failure,haemodynamic instability, haemoptysis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de la Sanrta Creu i Sant Pau

Barcelona, Barcelona, 08024, Spain

Location

Related Publications (1)

  • 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.

    PMID: 24890124DERIVED

MeSH Terms

Conditions

Lung Diseases, Interstitial

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

CytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2010

First Posted

February 8, 2010

Study Start

June 1, 2011

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

January 23, 2013

Record last verified: 2011-06

Locations

ES(1)