Ultrasonography Guided Pleural Biopsy Versus Computed Tomography Guided Pleural Biopsy

Study Overview
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Brief Summary
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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 Description
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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.

Official Title
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ULTRASONOGRAPHY GUIDED PLEURAL NEEDLE BIOPSY VERSUS COMPUTED TOMOGRAPHY GUIDED ABRAMS PLEURAL NEEDLE BIOPSY FOR DIAGNOSIS OF PATIENTS WITH PLEURAL EFFUSIONS: A RANDOMIZED CONTROLLED TRIAL

Conditions
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Pleural Diseases

Intervention / Treatment
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* Procedure: CT-Guided pleural needle biopsy with Abrams' needle
* Procedure: Ultrasonography guided cutting pleural needle biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with exudative pleural effusion who require invasive procedure for diagnosis Exclusion Criteria: Patients without pleural effusion

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the sensitivities and specificities of two diagnostic methods for pleural diseases to establish which method is more effective. | 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. | 28-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events as a measure of safety and tolerability. | 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. | 28-months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pleura, biopsy, diagnosis, CT, ultrasonography