Ultrasonography Guided Pleural Biopsy Versus Computed Tomography Guided Pleural Biopsy

This study has been completed.
Sponsor:
Information provided by:
Eskisehir Osmangazi University
ClinicalTrials.gov Identifier:
NCT01196585
First received: August 26, 2010
Last updated: May 16, 2011
Last verified: September 2010
  Purpose

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 Intervention
Pleural Diseases
Procedure: CT-Guided pleural needle biopsy with Abrams' needle
Procedure: Ultrasonography guided cutting pleural needle biopsy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Eskisehir Osmangazi University:

Primary Outcome Measures:
  • To compare the sensitivities and specificities of two diagnostic methods for pleural diseases to establish which method is more effective. [ Time Frame: 28-months ] [ Designated as safety issue: Yes ]
    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:
  • Number of participants with adverse events as a measure of safety and tolerability. [ Time Frame: 28-months ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 120
Study Start Date: April 2009
Study Completion Date: April 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients without pleural effusion
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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
Study First Received: August 26, 2010
Last Updated: May 16, 2011
Health Authority: Turkey: Ministry of Health

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

Additional relevant MeSH terms:
Pleural Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 20, 2014