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

Not Applicable

Completed

• Conditions: Diagnosis of Pleural Diseases
• Interventions: Procedure: Abrams' needle pleural biopsy (IG-ANPB) versus medical thoracoscopy in the diagnosis of pleural diseases.

• Registration Number: NCT05428891
• Lead Sponsor: Eskisehir Osmangazi University

Brief Summary

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

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.

Study Timeline

• Study Start: 2017-04-30
• Primary Completion: 2022-02-27
• Study Completion: 2022-05-01
• Study First Submitted: 2022-06-15
• Study First Submitted QC: 2022-06-17
• Study First Posted: 2022-06-23
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-07
• Last Update Posted: 2023-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 228

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Only pleural effusion	Abrams' needle pleural biopsy (IG-ANPB) versus medical thoracoscopy in the diagnosis of pleural diseases.	The patients with only pleural effusion on their CT scans.
Pleural effusion associated with pleural thickening or any other lesion like mass or nodules.	Abrams' needle pleural biopsy (IG-ANPB) versus medical thoracoscopy in the diagnosis of pleural diseases.	The patients with pleural effusion associated with pleural thickening or any other lesion-like mass or nodules on their CT scans.

Primary Outcome Measures

Name	Time	Method
The efficacy of pleural biopsy methods for the diagnosis of pleural diseases.	60 months	To compare the diagnostic efficacy and safety of imaging-guided Abrams needle biopsy with medical thoracoscopy.

Trial Locations

Locations (1)

Eskisehir Osmangazi University Medical Faculty Department of Chest Diseases; 🇹🇷 Eskisehir, Tepebaşı, Turkey