Ultrasonography Guided Pleural Biopsy Versus Computed Tomography Guided Pleural Biopsy

Pleural Diseases Clinical Trial

Official title:

ULTRASONOGRAPHY GUIDED PLEURAL NEEDLE BIOPSY VERSUS COMPUTED TOMOGRAPHY GUIDED ABRAMS PLEURAL NEEDLE BIOPSY FOR DIAGNOSIS OF PATIENTS WITH PLEURAL EFFUSIONS: A RANDOMIZED CONTROLLED TRIAL

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01196585
• Other study ID #: 082010/2
• Status: Completed
• Phase: N/A
• First received: August 26, 2010
• Last updated: May 16, 2011
• Start date: April 2009
• Est. completion date: April 2011

Study information

• Verified date: September 2010
• Source: Eskisehir Osmangazi University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 85 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Patients without pleural effusion

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Pleural Diseases

Intervention

Procedure:
• CT-Guided pleural needle biopsy with Abrams' needle
Patients will be randomized into two groups: Group A: CT-guided Abrams' needle biopsy.
• Ultrasonography guided cutting pleural needle biopsy
Patients will be randomized into two groups: Group B: Ultrasonography guided cutting-needle biopsy.

Locations

Country	Name	City	State
Turkey	Eskisehir Osmangazi University Medical Faculty department of Chest Diseases	Eskisehir

Sponsors (1)

Lead Sponsor	Collaborator
Eskisehir Osmangazi University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Metintas M, Ak G, Dundar E, Yildirim H, Ozkan R, Kurt E, Erginel S, Alatas F, Metintas S. Medical thoracoscopy vs CT scan-guided Abrams pleural needle biopsy for diagnosis of patients with pleural effusions: a randomized, controlled trial. Chest. 2010 Jun;137(6):1362-8. doi: 10.1378/chest.09-0884. Epub 2010 Feb 12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare the sensitivities and specificities of two diagnostic methods for pleural diseases to establish which method is more effective.	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.	28-months	Yes
Secondary	Number of participants with adverse events as a measure of safety and tolerability.	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.	28-months	Yes