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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05428891
Enrollment
228
Registered
2022-06-23
Start date
2017-04-30
Completion date
2022-05-01
Last updated
2023-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diagnosis of Pleural Diseases

Keywords

Pleura, Thoracoscopy, Pleural needle biopsy, Diagnosis

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.

Interventions

PROCEDUREAbrams' 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.

Sponsors

Eskisehir Osmangazi University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)

Masking description

Participants do not know which method will apply.

Intervention model description

Randomized prospective

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
The efficacy of pleural biopsy methods for the diagnosis of pleural diseases.60 monthsTo compare the diagnostic efficacy and safety of imaging-guided Abrams needle biopsy with medical thoracoscopy.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026