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| Sponsored by: |
Eskisehir Osmangazi University |
|---|---|
| Information provided by: | Eskisehir Osmangazi University |
| ClinicalTrials.gov Identifier: | NCT00720954 |
Purpose
The aim of this study is to compare the rigid thoracoscopy with CT-guided pleural needle biopsy by the diagnostic efficacy and safety in patients with pleural effusion.
| Condition | Intervention |
|---|---|
|
Pleural Effusion Pleural Diseases |
Procedure: Ct-guided pleural needle biopsy Procedure: Thoracoscopy |
| Study Type: | Interventional |
| Study Design: | Diagnostic, Randomized, Active Control, Safety/Efficacy Study |
| Official Title: | Rigid Thoracoscopy Versus CT-Guided Pleural Needle Biopsy For Diagnosis of Patients With Pleural Effusions: A Randomized Control Trial |
| Enrollment: | 124 |
| Study Start Date: | January 2006 |
| Study Completion Date: | June 2008 |
| Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
A
CT guided pleural needle biopsy
|
Procedure: Ct-guided pleural needle biopsy
Biopsy of pleura
|
|
B
Thoracoscopy
|
Procedure: Thoracoscopy
Biopsy of pleura
|
Pleural needle biopsy with Abrams needle, which can be performed by all chest physicians, is a simple, safe and cheap method of obtaining tissue from pleura, but its diagnostic rate is between 7 % -72 %, ~ 50 %. Problems for Abrams needle are scattered tumoral involvement on pleura, blind performance, small tissue sampling, to tend to early and dense fibrosis and usually involvement of lower pleural surface and diaphragmatic pleura.
Pleural needle biopsy with Abrams' needle, which can be performed by all chest physicians, if done with image guided and if this increase the diagnosis rate, the number of second procedure which is more expensive and hard will decrease. The study aims the comparison of rigid thoracoscopy with CT-guided pleural needle biopsy by the diagnostic efficacy and safety in patients with pleural effusion. It has been planned that a total of 120 patients accepted to the study who have pleural effusion at plain chest roentgenogram. All patients are being randomized after underwent contrast-enhanced CT. Undiagnosed patients of biopsy group are performed thoracoscopy and undiagnosed patients of thoracoscopy group followed up.
Two groups will compare by age, sex, Karnofsky performance status (KPS), diagnosis and complication rate.
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
| Responsible Party: | ( Dr. Muzaffer Metintas ) |
| Study ID Numbers: | 2007.11.008 |
| Study First Received: | July 21, 2008 |
| Last Updated: | July 22, 2008 |
| ClinicalTrials.gov Identifier: | NCT00720954 History of Changes |
| Health Authority: | Turkey: Ministry of Health |
|
Thoracoscopy Pleural needle biopsy Malignant pleural diseases Mesothelioma |
Diagnosis Pleurisy tuberculosis Patients with pleural diseases and pleural effusion should have been included in the study. |
|
Pleural Effusion Pleurisy Respiratory Tract Diseases Pleural Diseases |
Muscle Rigidity Mesothelioma Tuberculosis |
|
Pleural Effusion Respiratory Tract Diseases Pleural Diseases |
