Efficiency and Safety of Pleural Biopsy Methods in the Diagnosis of Pleural Diseases

NCT ID: NCT03153501

Last Updated: 2017-05-15

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

164 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-08

Study Completion Date

2017-04-30

Brief Summary

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Image-guided pleural biopsies, both ultrasound (US) or computed tomography (CT) guided, and medical thoracoscopy are important in the diagnosis of pleural disease. However, no consensus exists regarding which biopsy methods are appropriate for specific procedures.

In this prospective study, the investigators aimed to compare CT-scan guided pleural biopsy using an Abrams' needle (CT-ANPB) with US-assisted pleural biopsy using a cutting needle (US-CNPB)and medical thoracoscopy with respect to both diagnostic yield and safety.

Detailed Description

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The primary end point of this study was the determination of the sensitivity and the complication rates of the invasive methods, Abrams needle pleural biopsy, tru-cut needle pleural biopsy, medical thoracoscopy with respect to the diagnosis of pleural disease.

Conditions

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Diagnosis of Pleural Diseases Medical Thoracoscopy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Image guided biopsies Thoracoscopy

Study Groups

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Diagnostic arm

Patients with pleural diseases; malignant pleural diseases, tuberculous pleurisy, and other exudate required CT-guided Abrams needle biopsy, US-guided cutting needle biopsy, and medical thoracoscopy.

Group Type OTHER

CT-guided Abrams needle biopsy, US-guided cutting needle, medical thoracoscopy

Intervention Type DIAGNOSTIC_TEST

Interventions

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CT-guided Abrams needle biopsy, US-guided cutting needle, medical thoracoscopy

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Patients with pleural diseases

Exclusion Criteria

* Patients with other lung diseases
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

Responsible Party

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Muzaffer Metintas

Medical Faculty, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Muzaffer Metintas, MD

Role: PRINCIPAL_INVESTIGATOR

ESOGU Medical Faculty

Locations

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ESOGU Medical Faculty Department of Chest Diseases

Eskişehir, Meselik - Eskisehir, Turkey (Türkiye)

Site Status

Eskisehir Osmangazi University Medical Faculty

Eskişehir, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Kim SJ, Choi SM, Lee J, Lee CH, Lee SM, Yim JJ, Yoo CG, Kim YW, Han SK, Park YS. Medical Thoracoscopy in Pleural Disease: Experience from a One-Center Study. Tuberc Respir Dis (Seoul). 2017 Apr;80(2):194-200. doi: 10.4046/trd.2017.80.2.194. Epub 2017 Mar 31.

Reference Type BACKGROUND
PMID: 28416960 (View on PubMed)

Other Identifiers

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PR-11-01-31-21

Identifier Type: -

Identifier Source: org_study_id

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