Rigid Thoracoscopy Versus CT-Guided Pleural Needle Biopsy

Study Overview
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Brief Summary
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The aim of this study is to compare the rigid thoracoscopy with CT-guided pleural needle biopsy by the diagnostic efficacy and safety in patients with pleural effusion.

Detailed Description
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Pleural needle biopsy with Abrams needle, which can be performed by all chest physicians, is a simple, safe and cheap method of obtaining tissue from pleura, but its diagnostic rate is between 7 % -72 %,   50 %. Problems for Abrams needle are scattered tumoral involvement on pleura, blind performance, small tissue sampling, to tend to early and dense fibrosis and usually involvement of lower pleural surface and diaphragmatic pleura. Pleural needle biopsy with Abrams' needle, which can be performed by all chest physicians, if done with image guided and if this increase the diagnosis rate, the number of second procedure which is more expensive and hard will decrease. The study aims the comparison of rigid thoracoscopy with CT-guided pleural needle biopsy by the diagnostic efficacy and safety in patients with pleural effusion. It has been planned that a total of 120 patients accepted to the study who have pleural effusion at plain chest roentgenogram. All patients are being randomized after underwent contrast-enhanced CT. Undiagnosed patients of biopsy group are performed thoracoscopy and undiagnosed patients of thoracoscopy group followed up. Two groups will compare by age, sex, Karnofsky performance status (KPS), diagnosis and complication rate.

Official Title
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Rigid Thoracoscopy Versus CT-Guided Pleural Needle Biopsy For Diagnosis of Patients With Pleural Effusions: A Randomized Control Trial

Conditions
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Pleural Effusion, Pleural Diseases

Intervention / Treatment
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* Procedure: Ct-guided pleural needle biopsy
* Procedure: Thoracoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages between 18-85 Pleural effusion in conventional radiography At least 10x10 cm space in pleural space with effusion No bleeding diathesis Informed consent Exclusion Criteria: Patients who went under pleural biopsy before Arrythmia Hypertensive attack during biopsy Bleeding diathesis Hypoxemia

Ages Eligible for Study
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Minimum Age: 18 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: A<br>CT guided pleural needle biopsy | Procedure: Ct-guided pleural needle biopsy<br>* Biopsy of pleura<br>* Other names: Diagnose;|
| Other: B<br>Thoracoscopy | Procedure: Thoracoscopy<br>* Biopsy of pleura<br>* Other names: Diagnose;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy and safety of both thoracoscopy and CT-guided pleural needle biopsy for diagnosis of pleural diseases |  | 30 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the efficacy of pleural needle biopsy and thoracoscopy in relation to CT findings. |  | 30 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thoracoscopy, Pleural needle biopsy, Malignant pleural diseases, Mesothelioma, Diagnosis, Pleurisy tuberculosis, Patients with pleural diseases and pleural effusion should have been included in the study.