Clinical Trial: Ultrasonography Guided Pleural Biopsy Versus Computed Tomography Guided Pleural Biopsy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.

Detailed Summary:

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.


Sponsor: Eskisehir Osmangazi University

Current Primary Outcome: 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.


Original Primary Outcome: 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 ]

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.


Current Secondary Outcome: 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.


Original Secondary Outcome: 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 ]

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.


Information By: Eskisehir Osmangazi University

Dates:
Date Received: August 26, 2010
Date Started: April 2009
Date Completion:
Last Updated: May 16, 2011
Last Verified: September 2010