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Rigid Thoracoscopy Versus CT-Guided Pleural Needle Biopsy

NCT ID: NCT00720954

Last Updated: 2008-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2008-06-30

Brief Summary

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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

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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.

Conditions

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Pleural Effusion Pleural Diseases

Keywords

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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.

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

DIAGNOSTIC

Study Groups

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A

CT guided pleural needle biopsy

Group Type OTHER

Ct-guided pleural needle biopsy

Intervention Type PROCEDURE

Biopsy of pleura

B

Thoracoscopy

Group Type OTHER

Thoracoscopy

Intervention Type PROCEDURE

Biopsy of pleura

Interventions

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Ct-guided pleural needle biopsy

Biopsy of pleura

Intervention Type PROCEDURE

Thoracoscopy

Biopsy of pleura

Intervention Type PROCEDURE

Other Intervention Names

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Diagnose Diagnose

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eskisehir Osmangazi University

OTHER

Sponsor Role lead

Locations

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ESOGU MEDICAL FACULTY DEPARTMENT of CHEST DISEASES

Eskişehir, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Metintas M, Ak G, Dundar E, Yildirim H, Ozkan R, Kurt E, Erginel S, Alatas F, Metintas S. Medical thoracoscopy vs CT scan-guided Abrams pleural needle biopsy for diagnosis of patients with pleural effusions: a randomized, controlled trial. Chest. 2010 Jun;137(6):1362-8. doi: 10.1378/chest.09-0884. Epub 2010 Feb 12.

Reference Type DERIVED
PMID: 20154079 (View on PubMed)

Related Links

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http://www.ogu.edu.tr

University

Other Identifiers

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2007.11.008

Identifier Type: -

Identifier Source: org_study_id