Pleural Diseases
Conditions
Keywords
Pleura, biopsy, diagnosis, CT, ultrasonography
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.
Interventions
PROCEDURECT-Guided pleural needle biopsy with Abrams' needle
Patients will be randomized into two groups: Group A: CT-guided Abrams' needle biopsy.
PROCEDUREUltrasonography guided cutting pleural needle biopsy
Patients will be randomized into two groups: Group B: Ultrasonography guided cutting-needle biopsy.
Sponsors
Eskisehir Osmangazi University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Patients with exudative pleural effusion who require invasive procedure for diagnosis
Exclusion criteria
* Patients without pleural effusion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed