Ultrasonography Guided Pleural Biopsy Versus Computed Tomography Guided Pleural Biopsy

Not Applicable

Completed

• Conditions: Pleural Diseases
• Interventions: Procedure: CT-Guided pleural needle biopsy with Abrams' needle; Procedure: Ultrasonography guided cutting pleural needle biopsy

• Registration Number: NCT01196585
• Lead Sponsor: Eskisehir Osmangazi University

Brief Summary

This study aims to compare the diagnostic efficiency and reliability of Abrams' needle pleural biopsy under computerized tomography guidance with that of cutting-needle pleural biopsy under ultrasonography guidance in patients with pleural effusion.

Detailed Description

Background. In cases with pleural effusion, tissue samples can be obtained through Abrams' needle pleural biopsy, thoracoscopy, or cutting-needle pleural biopsy under the guidance of computerized tomography or ultrasonography for histopathological analysis. This study aims to compare the diagnostic efficiency and reliability of Abrams' needle pleural biopsy under computerized tomography guidance with that of cutting-needle pleural biopsy under ultrasonography guidance in patients with pleural effusion.

Methods. Patients with exudative pleural effusion, who could not be diagnosed by cytological analysis, will be included in the study. All patients were randomized following the thoracic computerized tomography with contrast enhancement. Patients either underwent Abrams' needle pleural biopsy under computerized tomography guidance or the cutting-needle pleural biopsy under ultrasonography. The two groups will be compared in terms of diagnostic efficiency and in terms of complications associated with the methods used.

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2010-08-26
• Status Verified: 2010-09
• Study First Submitted QC: 2010-09-07
• Study First Posted: 2010-09-08
• Primary Completion: 2011-01
• Study Completion: 2011-04
• Last Update Submitted: 2011-05-16
• Last Update Posted: 2011-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Patients with exudative pleural effusion who require invasive procedure for diagnosis

Exclusion Criteria

• Patients without pleural effusion

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients under CT- guided pleural biopsy	CT-Guided pleural needle biopsy with Abrams' needle	Arm A: Patients who go under CT-guided pleural needle biopsy for pleural diseases
Patients under ultrasonography guided needle biopsy	Ultrasonography guided cutting pleural needle biopsy	Arm B: Patients who go under ultrasonography guided cutting needle pleural biopsy for pleural diseases

Primary Outcome Measures

Name	Time	Method
To compare the sensitivities and specificities of two diagnostic methods for pleural diseases to establish which method is more effective.	28-months	The investigators will determine which method more efficient for the diagnosis of pleural diseases establishing sensitivity and specificity of the methods. After establishment of sensitivity, specificity and side effects for each diagnostic method the investigators will compare them according to the method and determine which method is more efficient.

Secondary Outcome Measures

Name	Time	Method
Number of participants with adverse events as a measure of safety and tolerability.	28-months	All patients in both arm will be followed for complications of the diagnostic method. Complications experienced by the patients will be determined and recorded in special forms. Each complication will be measured with own characteristic such as pain, local infection, pneumothorax,local inavsion of disease, haemoragy etc.

Trial Locations

Locations (1)

Eskisehir Osmangazi University Medical Faculty department of Chest Diseases; 🇹🇷 Eskisehir, Turkey