Rigid Thoracoscopy Versus CT-Guided Pleural Needle Biopsy

Not Applicable

Completed

• Conditions: Pleural Effusion; Pleural Diseases
• Interventions: Procedure: Ct-guided pleural needle biopsy; Procedure: Thoracoscopy

• Registration Number: NCT00720954
• Lead Sponsor: Eskisehir Osmangazi University

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 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.

Study Timeline

• Study Start: 2006-01
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Status Verified: 2008-07
• Study First Submitted: 2008-07-21
• Study First Submitted QC: 2008-07-22
• Last Update Submitted: 2008-07-22
• Study First Posted: 2008-07-23
• Last Update Posted: 2008-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

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

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A	Ct-guided pleural needle biopsy	CT guided pleural needle biopsy
B	Thoracoscopy	Thoracoscopy

Primary Outcome Measures

Name	Time	Method
Efficacy and safety of both thoracoscopy and CT-guided pleural needle biopsy for diagnosis of pleural diseases	30 months

Secondary Outcome Measures

Name	Time	Method
Determine the efficacy of pleural needle biopsy and thoracoscopy in relation to CT findings.	30 months

Trial Locations

Locations (1)

ESOGU MEDICAL FACULTY DEPARTMENT of CHEST DISEASES; 🇹🇷 Eskisehir, Turkey