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

August 26, 2010
May 16, 2011
April 2009
January 2011   (final data collection date for primary outcome measure)
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.
Number of Participants with true diagnosis and number of participants with adverse events as a measure of safety and tolerability. [ Time Frame: in 28-month duration ] [ 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. Also 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.
Complete list of historical versions of study NCT01196585 on ClinicalTrials.gov Archive Site
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.
To compare the sensitivities and specificities of two diagnostic methods for pleural diseases to establish which method is more effective and also to compare the rate of the side effects in respect to diagnostic methods. [ Time Frame: 28-month ] [ Designated as safety issue: Yes ]
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 and safe.
Not Provided
Not Provided
 
Ultrasonography Guided Pleural Biopsy Versus Computed Tomography Guided Pleural Biopsy
ULTRASONOGRAPHY GUIDED PLEURAL NEEDLE BIOPSY VERSUS COMPUTED TOMOGRAPHY GUIDED ABRAMS PLEURAL NEEDLE BIOPSY FOR DIAGNOSIS OF PATIENTS WITH PLEURAL EFFUSIONS: A RANDOMIZED CONTROLLED TRIAL

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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.
  • Procedure: Ultrasonography guided cutting pleural needle biopsy
    Patients will be randomized into two groups: Group B: Ultrasonography guided cutting-needle biopsy.
  • Experimental: Patients under CT- guided pleural biopsy
    Arm A: Patients who go under CT-guided pleural needle biopsy for pleural diseases
    Intervention: Procedure: CT-Guided pleural needle biopsy with Abrams' needle
  • Experimental: Patients under ultrasonography guided needle biopsy
    Arm B: Patients who go under ultrasonography guided cutting needle pleural biopsy for pleural diseases
    Intervention: Procedure: Ultrasonography guided cutting pleural needle biopsy
Metintas M, Ak G, Dundar E, Yildirim H, Ozkan R, Kurt E, Erginel S, Alatas F, Metintas S. Medical thoracoscopy vs CT scan-guided Abrams pleural needle biopsy for diagnosis of patients with pleural effusions: a randomized, controlled trial. Chest. 2010 Jun;137(6):1362-8. doi: 10.1378/chest.09-0884. Epub 2010 Feb 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
April 2011
January 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients without pleural effusion
Both
20 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Turkey
 
NCT01196585
082010/2
Yes
Muzaffer Metintas, ESOGU Medical Faculty Department of Chest Diseases
Eskisehir Osmangazi University
Not Provided
Principal Investigator: Muzaffer Metintas, Professor ESOGU Medical Faculty
Eskisehir Osmangazi University
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP