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

NCT ID: NCT05428891

Last Updated: 2023-09-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 228 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-30
• Study Completion Date: 2022-05-01

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.

Conditions

Diagnosis of Pleural Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Only pleural effusion

The patients with only pleural effusion on their CT scans.

Group Type: OTHER

Abrams' needle pleural biopsy (IG-ANPB) versus medical thoracoscopy in the diagnosis of pleural diseases.

Intervention Type: PROCEDURE

We compare the diagnostic efficacy and safety of imaging-guided Abrams needle biopsy with medical thoracoscopy.

Pleural effusion associated with pleural thickening or any other lesion like mass or nodules.

The patients with pleural effusion associated with pleural thickening or any other lesion-like mass or nodules on their CT scans.

Group Type: OTHER

Abrams' needle pleural biopsy (IG-ANPB) versus medical thoracoscopy in the diagnosis of pleural diseases.

Intervention Type: PROCEDURE

We compare the diagnostic efficacy and safety of imaging-guided Abrams needle biopsy with medical thoracoscopy.

Interventions

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.

Intervention Type: PROCEDURE

Other Intervention Names

A diagnostic algorithm for pleural diseases.

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eskisehir Osmangazi University

OTHER

Sponsor Role: lead

Responsible Party

Muzaffer Metintas

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Muzaffer Metintas, Prof.

Role: PRINCIPAL_INVESTIGATOR

Eskisehir Osmangazi University Medical Faculty Department of Chest Diseases

Locations

Eskisehir Osmangazi University Medical Faculty Department of Chest Diseases

Eskişehir, Tepebaşı, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Metintas M, Ak G, Yildirim H, Dundar E, Aydin N, Erginel S, Alatas F, Yilmaz S, Metintas S. Image-Assisted Pleural Needle Biopsy or Medical Thoracoscopy: Which Method for Which Patient? A Randomized Controlled Trial. Chest. 2024 Aug;166(2):405-412. doi: 10.1016/j.chest.2024.03.038. Epub 2024 Mar 28.

Reference Type: DERIVED

PMID: 38554817 (View on PubMed)

Other Identifiers

80558721/162

Identifier Type: -

Identifier Source: org_study_id