Ultrasonography Guided Pleural Biopsy Versus Computed Tomography Guided Pleural Biopsy

NCT ID: NCT01196585

Last Updated: 2011-05-17

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

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2011-04-30

Brief Summary

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This study aims to compare the diagnostic efficiency and reliability of Abrams' needle pleural biopsy under computerized tomography guidance with that of cutting-needle pleural biopsy under ultrasonography guidance in patients with pleural effusion.

Detailed Description

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Background. In cases with pleural effusion, tissue samples can be obtained through Abrams' needle pleural biopsy, thoracoscopy, or cutting-needle pleural biopsy under the guidance of computerized tomography or ultrasonography for histopathological analysis. This study aims to compare the diagnostic efficiency and reliability of Abrams' needle pleural biopsy under computerized tomography guidance with that of cutting-needle pleural biopsy under ultrasonography guidance in patients with pleural effusion.

Methods. Patients with exudative pleural effusion, who could not be diagnosed by cytological analysis, will be included in the study. All patients were randomized following the thoracic computerized tomography with contrast enhancement. Patients either underwent Abrams' needle pleural biopsy under computerized tomography guidance or the cutting-needle pleural biopsy under ultrasonography. The two groups will be compared in terms of diagnostic efficiency and in terms of complications associated with the methods used.

Conditions

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Pleural Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patients under CT- guided pleural biopsy

Arm A: Patients who go under CT-guided pleural needle biopsy for pleural diseases

Group Type EXPERIMENTAL

CT-Guided pleural needle biopsy with Abrams' needle

Intervention Type PROCEDURE

Patients will be randomized into two groups: Group A: CT-guided Abrams' needle biopsy.

Patients under ultrasonography guided needle biopsy

Arm B: Patients who go under ultrasonography guided cutting needle pleural biopsy for pleural diseases

Group Type EXPERIMENTAL

Ultrasonography guided cutting pleural needle biopsy

Intervention Type PROCEDURE

Patients will be randomized into two groups: Group B: Ultrasonography guided cutting-needle biopsy.

Interventions

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CT-Guided pleural needle biopsy with Abrams' needle

Patients will be randomized into two groups: Group A: CT-guided Abrams' needle biopsy.

Intervention Type PROCEDURE

Ultrasonography guided cutting pleural needle biopsy

Patients will be randomized into two groups: Group B: Ultrasonography guided cutting-needle biopsy.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients with exudative pleural effusion who require invasive procedure for diagnosis

Exclusion Criteria

* Patients without pleural effusion
Minimum Eligible Age

20 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

Responsible Party

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ESOGU Medical Faculty Department of Chest Diseases

Principal Investigators

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Muzaffer Metintas, Professor

Role: PRINCIPAL_INVESTIGATOR

ESOGU Medical Faculty

Locations

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Eskisehir Osmangazi University 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 BACKGROUND
PMID: 20154079 (View on PubMed)

Other Identifiers

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082010/2

Identifier Type: -

Identifier Source: org_study_id

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