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

Diagnosis of Pleural Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05428891
• Other study ID #: 80558721/162
• Status: Completed
• Phase: N/A
• Start date: April 30, 2017
• Est. completion date: May 1, 2022

Study information

• Verified date: September 2023
• Source: Eskisehir Osmangazi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 228
• Est. completion date: May 1, 2022
• Est. primary completion date: February 27, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diagnosis of Pleural Diseases
• Disease
• Pleural Diseases

Intervention

Procedure:
• Abrams' needle pleural biopsy (IG-ANPB) versus medical thoracoscopy in the diagnosis of pleural diseases.
We compare the diagnostic efficacy and safety of imaging-guided Abrams needle biopsy with medical thoracoscopy.

Locations

Country	Name	City	State
Turkey	Eskisehir Osmangazi University Medical Faculty Department of Chest Diseases	Eskisehir	Tepebasi

Sponsors (1)

Lead Sponsor	Collaborator
Eskisehir Osmangazi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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