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Ultrasonography Guided Pleural Biopsy Versus Computed Tomography Guided Pleural Biopsy

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ClinicalTrials.gov Identifier: NCT01196585
Recruitment Status : Completed
First Posted : September 8, 2010
Last Update Posted : May 17, 2011
Sponsor:
Information provided by:
Eskisehir Osmangazi University

Brief Summary:
This study aims to compare the diagnostic efficiency and reliability of Abrams' needle pleural biopsy under computerized tomography guidance with that of cutting-needle pleural biopsy under ultrasonography guidance in patients with pleural effusion.

Condition or disease Intervention/treatment
Pleural Diseases Procedure: CT-Guided pleural needle biopsy with Abrams' needle Procedure: Ultrasonography guided cutting pleural needle biopsy

Detailed Description:

Background. In cases with pleural effusion, tissue samples can be obtained through Abrams' needle pleural biopsy, thoracoscopy, or cutting-needle pleural biopsy under the guidance of computerized tomography or ultrasonography for histopathological analysis. This study aims to compare the diagnostic efficiency and reliability of Abrams' needle pleural biopsy under computerized tomography guidance with that of cutting-needle pleural biopsy under ultrasonography guidance in patients with pleural effusion.

Methods. Patients with exudative pleural effusion, who could not be diagnosed by cytological analysis, will be included in the study. All patients were randomized following the thoracic computerized tomography with contrast enhancement. Patients either underwent Abrams' needle pleural biopsy under computerized tomography guidance or the cutting-needle pleural biopsy under ultrasonography. The two groups will be compared in terms of diagnostic efficiency and in terms of complications associated with the methods used.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: ULTRASONOGRAPHY GUIDED PLEURAL NEEDLE BIOPSY VERSUS COMPUTED TOMOGRAPHY GUIDED ABRAMS PLEURAL NEEDLE BIOPSY FOR DIAGNOSIS OF PATIENTS WITH PLEURAL EFFUSIONS: A RANDOMIZED CONTROLLED TRIAL
Study Start Date : April 2009
Primary Completion Date : January 2011
Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Patients under CT- guided pleural biopsy
Arm A: Patients who go under CT-guided pleural needle biopsy for pleural diseases
Procedure: CT-Guided pleural needle biopsy with Abrams' needle
Patients will be randomized into two groups: Group A: CT-guided Abrams' needle biopsy.
Experimental: Patients under ultrasonography guided needle biopsy
Arm B: Patients who go under ultrasonography guided cutting needle pleural biopsy for pleural diseases
Procedure: Ultrasonography guided cutting pleural needle biopsy
Patients will be randomized into two groups: Group B: Ultrasonography guided cutting-needle biopsy.



Primary Outcome Measures :
  1. To compare the sensitivities and specificities of two diagnostic methods for pleural diseases to establish which method is more effective. [ Time Frame: 28-months ]
    The investigators will determine which method more efficient for the diagnosis of pleural diseases establishing sensitivity and specificity of the methods. After establishment of sensitivity, specificity and side effects for each diagnostic method the investigators will compare them according to the method and determine which method is more efficient.


Secondary Outcome Measures :
  1. Number of participants with adverse events as a measure of safety and tolerability. [ Time Frame: 28-months ]
    All patients in both arm will be followed for complications of the diagnostic method. Complications experienced by the patients will be determined and recorded in special forms. Each complication will be measured with own characteristic such as pain, local infection, pneumothorax,local inavsion of disease, haemoragy etc.



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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with exudative pleural effusion who require invasive procedure for diagnosis

Exclusion Criteria:

  • Patients without pleural effusion

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01196585


Locations
Turkey
Eskisehir Osmangazi University Medical Faculty department of Chest Diseases
Eskisehir, Turkey
Sponsors and Collaborators
Eskisehir Osmangazi University
Investigators
Principal Investigator: Muzaffer Metintas, Professor ESOGU Medical Faculty

Publications:
Responsible Party: Muzaffer Metintas, ESOGU Medical Faculty Department of Chest Diseases
ClinicalTrials.gov Identifier: NCT01196585     History of Changes
Other Study ID Numbers: 082010/2
First Posted: September 8, 2010    Key Record Dates
Last Update Posted: May 17, 2011
Last Verified: September 2010

Keywords provided by Eskisehir Osmangazi University:
Pleura
biopsy
diagnosis
CT
ultrasonography

Additional relevant MeSH terms:
Pleural Diseases
Respiratory Tract Diseases