Diagnostic Yield and Safety of Transbronchial Lung Biopsy Using Cryoprobes Versus Conventional Forceps. A Multicenter Study

September 27, 2017 updated by: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
The purpose of this study is to evaluate the diagnostic yield and safety of transbronchial lung biopsies (TBLB) with cryoprobe versus conventional forceps in patients with diffuse lung disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08025
        • Hospital de la Santa Creu i Sant Pau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • >18 years old
  • Patients with diffuse lung disease candidate to study with transbronchial lung biopsy (TBLB).
  • Inform consent signed.

Exclusion Criteria:

  • FEV1 <40% of reference value.
  • Respiratory insufficiency (pO2 <60 mmHg or pCO2 >45 mmHg).
  • Use of anticoagulant therapy or presence of a coagulation (disorder abnormal platelets counts, international normalized ratio > 1.5).
  • Bullous emphysema.
  • Pulmonary arterial hypertension.
  • Hypersensitivity to anaesthetic and sedative drugs (lidocaine, midazolam, propofol, remifentanyl).
  • Psychiatric illness.
  • Comorbidities that could increase the risk of the TBLB.
  • Pregnancy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Biopsy with Cryoprobes
Transbronchial lung biopsy with a cryoprobe.
Procedure: Transbronchial lung biopsy.
Transbronchial lung biopsy with cryoprobe and with conventional forceps.
Active Comparator: Biopsy with Conventional Forceps
Transbronchial lung biopsy with conventional forceps.
Procedure: Transbronchial lung biopsy.
Transbronchial lung biopsy with cryoprobe and with conventional forceps.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic yield of transbronchial lung biopsy (TBLB)
Time Frame: 24 months
Comparing those TBLB obtained by cryoprobes versus conventional forceps (number of diagnosis with each technique).
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Histological quality of samples as defined the presence of alveolar units in each sample. Composite measure.
Time Frame: 24 months
The quality of samples are defined by the size, presence of artifacts and presence of alveolar units in each sample.
24 months
Safety related to the procedure of the TBLB obtained by cryoprobe compared with conventional forceps assessed by chest radiography.
Time Frame: 24 months
Chest radiography after TBLB.
24 months
Safety related to the procedure of the TBLB obtained by cryoprobe compared with conventional forceps assessed by control of bleeding.
Time Frame: 24 months
Control of bleeding during procedure.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Collaborators

Germans Trias i Pujol Hospital
Hospital Universitari de Bellvitge
Hospital Universitario La Fe
University of Salamanca
Hospital General Universitario Santa Lucia
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Complejo Hospitalario Universitario de Vigo
Hospital Universitario de Valladolid

Investigators

  • Principal Investigator: Virginia Pajares, PhD, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2014

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

May 6, 2015

First Submitted That Met QC Criteria

June 3, 2015

First Posted (Estimate)

June 8, 2015

Study Record Updates

Last Update Posted (Actual)

September 29, 2017

Last Update Submitted That Met QC Criteria

September 27, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIBSP-CRI-2014-05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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