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Completed

NCT Number: NCT01196585

Ultrasonography Guided Pleural Biopsy Versus Computed Tomography Guided Pleural Biopsy

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.

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Key information

Conditions

Pleural Diseases Disease Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eskisehir Osmangazi University Medical Faculty department of Chest Diseases

Eskişehir, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patients without pleural effusion

Treatment and study plan

CT-Guided pleural needle biopsy with Abrams' needle

Procedure

Patients will be randomized into two groups: Group A: CT-guided Abrams' needle biopsy.

Ultrasonography guided cutting pleural needle biopsy

Procedure

Patients will be randomized into two groups: Group B: Ultrasonography guided cutting-needle biopsy.

Primary outcomes

  1. To compare the sensitivities and specificities of two diagnostic methods for pleural diseases to establish which method is more effective.

    Time frame: 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 outcomes

  1. Number of participants with adverse events as a measure of safety and tolerability.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Eskisehir Osmangazi University

Other

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Sep 8, 2010
Registry last updated
May 17, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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