Efficiency and Safety of Pleural Biopsy Methods in the Diagnosis of Pleural Diseases

Not Applicable

Completed

• Conditions: Medical Thoracoscopy; Diagnosis of Pleural Diseases
• Interventions: Diagnostic Test: CT-guided Abrams needle biopsy, US-guided cutting needle, medical thoracoscopy

• Registration Number: NCT03153501
• Lead Sponsor: Eskisehir Osmangazi University

Brief Summary

Image-guided pleural biopsies, both ultrasound (US) or computed tomography (CT) guided, and medical thoracoscopy are important in the diagnosis of pleural disease. However, no consensus exists regarding which biopsy methods are appropriate for specific procedures.

In this prospective study, the investigators aimed to compare CT-scan guided pleural biopsy using an Abrams' needle (CT-ANPB) with US-assisted pleural biopsy using a cutting needle (US-CNPB)and medical thoracoscopy with respect to both diagnostic yield and safety.

Detailed Description

The primary end point of this study was the determination of the sensitivity and the complication rates of the invasive methods, Abrams needle pleural biopsy, tru-cut needle pleural biopsy, medical thoracoscopy with respect to the diagnosis of pleural disease.

Study Timeline

• Study Start: 2011-02-08
• Primary Completion: 2017-02-01
• Study Completion: 2017-04-30
• Status Verified: 2017-05
• Study First Submitted: 2017-05-04
• Study First Submitted QC: 2017-05-12
• Last Update Submitted: 2017-05-12
• Study First Posted: 2017-05-15
• Last Update Posted: 2017-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 164

Inclusion Criteria

• Patients with pleural diseases

Exclusion Criteria

• Patients with other lung diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic arm	CT-guided Abrams needle biopsy, US-guided cutting needle, medical thoracoscopy	Patients with pleural diseases; malignant pleural diseases, tuberculous pleurisy, and other exudate required CT-guided Abrams needle biopsy, US-guided cutting needle biopsy, and medical thoracoscopy.

Primary Outcome Measures

Name	Time	Method
Diagnostic efficiencies of pleural biopsy methods; CT-guided Abrams needle, US-guided cutting needle and medical thoracoscopy in the diagnosis of pleural diseases: The sensitivity, specificity, negative predictive value and positive predictive value.	5 years	The sensitivity, specificity, negative predictive value and positive predictive value of computed tomography guided Abrams needle pleural biopsy, ultrasonography guided cutting needle biopsy and medical thoracoscopy techniques in the diagnosis of pleural diseases.
Safety of pleural biopsy methods; CT-guided Abrams needle, US-guided cutting needle and medical thoracoscopy in the diagnosis of pleural diseases: Rate of side effects.	5 years	Rate of side effects comparing to each other for computed tomography guided Abrams needle pleural biopsy, ultrasonography guided cutting needle biopsy and medical thoracoscopy techniques in the diagnosis of pleural diseases.

Trial Locations

Locations (2)

Eskisehir Osmangazi University Medical Faculty; 🇹🇷 Eskişehir, Turkey

ESOGU Medical Faculty Department of Chest Diseases; 🇹🇷 Eskisehir, Meselik - Eskisehir, Turkey