Image-guided Pleural Biopsy or Medical Thoracosocopy in Diagnosis of Pleural Disease

Study Overview
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Brief Summary
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Pleural diseases can occur due to numerous pathological conditions. The increasing prevalence of etiologic causes and aging population worldwide will make pleural diseases a growing problem in the coming years. As a result of this increase, the need for diagnostic investigations is also increasing. In recent years, the use of image-guided needle biopsies under ultrasound (US) or computed tomography (CT) and the increasing use of medical thoracoscopy (MT) have significantly increased the accuracy of diagnosis of pleural disease. There is not yet a generally accepted algorithm for invasive diagnosis of pleural disease, widely used in clinics, that determines which method should be used in which patient. It would be necessary and valuable to develop an algorithm based on imaging findings in particular to improve the diagnostic accuracy, safety, and cost of the procedure. The investigators aimed to test the algorithm in an interventional study to increase the level of evidence in this study.

Detailed Description
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No consensus exists regarding which biopsy methods are appropriate for specific procedures. In this randomized prospective study, the investigators aimed to compare image guided - pleural biopsy using an Abrams' needle (IG-ANPB) with medical thoracoscopy (MT) according to the CT findings of the patients concerning both diagnostic yield and safety. Between May 2017 and March 2022, 228 patients with exudative pleural effusion who the cytological analysis could not diagnose were included. All patients were separated into two groups regarding the CT findings: Only pleural effusion or pleural effusion with pleural thickening/lesion. In each group, the patients were randomized to either underwent IG-ANPB or underwent MT. The two groups were compared in terms of diagnostic sensitivity, accuracy, and complications.

Official Title
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Image-guided Pleural Needle Biopsy or Medical Thoracoscopy: Which Method for Which Patient? A Randomized Controlled Trial

Conditions
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Diagnosis of Pleural Diseases

Intervention / Treatment
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* Procedure: Abrams' needle pleural biopsy (IG-ANPB) versus medical thoracoscopy in the diagnosis of pleural diseases.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pleural effusion Malignant pleural diseases Pleurisy tuberculosis Benign pleural diseases Exclusion Criteria: Age less than 18 years, Parapneumonic effusion, Presence of other systemic diseases that could interfere radiological evaluation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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
Interventional Model Description: Randomized prospective
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Only pleural effusion<br>The patients with only pleural effusion on their CT scans. | Procedure: Abrams' needle pleural biopsy (IG-ANPB) versus medical thoracoscopy in the diagnosis of pleural diseases.<br>* We compare the diagnostic efficacy and safety of imaging-guided Abrams needle biopsy with medical thoracoscopy.<br>* Other names: A diagnostic algorithm for pleural diseases.;|
| Other: Pleural effusion associated with pleural thickening or any other lesion like mass or nodules.<br>The patients with pleural effusion associated with pleural thickening or any other lesion-like mass or nodules on their CT scans. | Procedure: Abrams' needle pleural biopsy (IG-ANPB) versus medical thoracoscopy in the diagnosis of pleural diseases.<br>* We compare the diagnostic efficacy and safety of imaging-guided Abrams needle biopsy with medical thoracoscopy.<br>* Other names: A diagnostic algorithm for pleural diseases.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The efficacy of pleural biopsy methods for the diagnosis of pleural diseases. | To compare the diagnostic efficacy and safety of imaging-guided Abrams needle biopsy with medical thoracoscopy. | 60 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pleura, Thoracoscopy, Pleural needle biopsy, Diagnosis