Clinical trial NCT01196585: Ultrasonography Guided Pleural Biopsy Versus Computed Tomography Guided Pleural Biopsy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pleural Diseases
Keywords: Pleura
biopsy
diagnosis
CT
ultrasonography
Lead sponsor: Eskisehir Osmangazi University
Sponsor class: OTHER
First posted: 2010-09-08
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Patients without pleural effusion

Primary outcomes:
measure: To compare the sensitivities and specificities of two diagnostic methods for pleural diseases to establish which method is more effective.
timeFrame: 28-months
Secondary outcomes:
measure: Number of participants with adverse events as a measure of safety and tolerability.
timeFrame: 28-months
Other outcomes:
Locations:
city: Eskisehir
country: Turkey
facility: Eskisehir Osmangazi University Medical Faculty department of Chest Diseases
Study officials:
affiliation: ESOGU Medical Faculty
name: Muzaffer Metintas, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.