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NCT00720954 Clinical Trial

Rigid Thoracoscopy Versus CT-Guided Pleural Needle Biopsy

Pleural Effusion Clinical Trial

Official title:
Rigid Thoracoscopy Versus CT-Guided Pleural Needle Biopsy For Diagnosis of Patients With Pleural Effusions: A Randomized Control Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00720954
Other study ID # 2007.11.008
Secondary ID
Status Completed
Phase N/A
First received July 21, 2008
Last updated July 22, 2008
Start date January 2006
Est. completion date June 2008

Study information
Verified date July 2008
Source Eskisehir Osmangazi University
Contact n/a
Is FDA regulated No
Health authority Turkey: Ministry of Health
Study type Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 124
Est. completion date June 2008
Est. primary completion date June 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria:

1. Ages between 18-85

2. Pleural effusion in conventional radiography

3. At least 10x10 cm space in pleural space with effusion

4. No bleeding diathesis

5. Informed consent

Exclusion Criteria:

1. Patients who went under pleural biopsy before

2. Arrythmia

3. Hypertensive attack during biopsy

4. Bleeding diathesis

5. Hypoxemia

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Procedure:
• Ct-guided pleural needle biopsy
Biopsy of pleura
• Thoracoscopy
Biopsy of pleura

Locations
Country Name City State
Turkey ESOGU MEDICAL FACULTY DEPARTMENT of CHEST DISEASES Eskisehir

Sponsors (1)
Lead Sponsor Collaborator
Eskisehir Osmangazi University

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Efficacy and safety of both thoracoscopy and CT-guided pleural needle biopsy for diagnosis of pleural diseases 30 months
Secondary Determine the efficacy of pleural needle biopsy and thoracoscopy in relation to CT findings. 30 months
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