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

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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 228
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Tepebaşı
    • Eskisehir, Tepebaşı, Turkey, 260140
      • Eskisehir Osmangazi University Medical Faculty Department of Chest Diseases

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 86 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Only pleural effusion; 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.; We compare the diagnostic efficacy and safety of imaging-guided Abrams needle biopsy with medical thoracoscopy.; Other Names: A diagnostic algorithm for pleural diseases.
Other: 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.	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.; Other Names: A diagnostic algorithm for pleural diseases.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Eskisehir Osmangazi University
• Investigators: Principal Investigator: Muzaffer Metintas, Prof., Eskisehir Osmangazi University Medical Faculty Department of Chest Diseases

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2017
• Primary Completion (Actual): February 27, 2022
• Study Completion (Actual): May 1, 2022

Study Registration Dates

• First Submitted: June 15, 2022
• First Submitted That Met QC Criteria: June 17, 2022
• First Posted (Actual): June 23, 2022

Study Record Updates

• Last Update Posted (Actual): September 11, 2023
• Last Update Submitted That Met QC Criteria: September 7, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Diagnosis; Thoracoscopy; Pleura; Pleural needle biopsy
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease; Pleural Diseases
• Other Study ID Numbers: 80558721/162

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No