Ultrasonography Guided Pleural Biopsy Versus Computed Tomography Guided Pleural Biopsy
|ClinicalTrials.gov Identifier: NCT01196585|
Recruitment Status : Completed
First Posted : September 8, 2010
Last Update Posted : May 17, 2011
|Condition or disease||Intervention/treatment||Phase|
|Pleural Diseases||Procedure: CT-Guided pleural needle biopsy with Abrams' needle Procedure: Ultrasonography guided cutting pleural needle biopsy||Not Applicable|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Primary Completion Date :||January 2011|
|Actual Study Completion Date :||April 2011|
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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01196585
|Eskisehir Osmangazi University Medical Faculty department of Chest Diseases|
|Principal Investigator:||Muzaffer Metintas, Professor||ESOGU Medical Faculty|