Clinical Trial: Rigid Thoracoscopy Versus CT-Guided Pleural Needle Biopsy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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.

Detailed Summary:

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.

Sponsor: Eskisehir Osmangazi University

Current Primary Outcome: Efficacy and safety of both thoracoscopy and CT-guided pleural needle biopsy for diagnosis of pleural diseases [ Time Frame: 30 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Determine the efficacy of pleural needle biopsy and thoracoscopy in relation to CT findings. [ Time Frame: 30 months ]

Original Secondary Outcome: Same as current

Information By: Eskisehir Osmangazi University

Dates:
Date Received: July 21, 2008
Date Started: January 2006
Date Completion:
Last Updated: July 22, 2008
Last Verified: July 2008