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Ultrasonography Guided Pleural Biopsy Versus Computed Tomography Guided Pleural Biopsy

Primary Purpose

Pleural Diseases

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
CT-Guided pleural needle biopsy with Abrams' needle
Ultrasonography guided cutting pleural needle biopsy
Sponsored by
Eskisehir Osmangazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pleural Diseases focused on measuring Pleura, biopsy, diagnosis, CT, ultrasonography

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients without pleural effusion

Sites / Locations

  • Eskisehir Osmangazi University Medical Faculty department of Chest Diseases

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Patients under CT- guided pleural biopsy

Patients under ultrasonography guided needle biopsy

Arm Description

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

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

Outcomes

Primary Outcome Measures

To compare the sensitivities and specificities of two diagnostic methods for pleural diseases to establish which method is more effective.
The investigators will determine which method more efficient for the diagnosis of pleural diseases establishing sensitivity and specificity of the methods. After establishment of sensitivity, specificity and side effects for each diagnostic method the investigators will compare them according to the method and determine which method is more efficient.

Secondary Outcome Measures

Number of participants with adverse events as a measure of safety and tolerability.
All patients in both arm will be followed for complications of the diagnostic method. Complications experienced by the patients will be determined and recorded in special forms. Each complication will be measured with own characteristic such as pain, local infection, pneumothorax,local inavsion of disease, haemoragy etc.

Full Information

First Posted
August 26, 2010
Last Updated
May 16, 2011
Sponsor
Eskisehir Osmangazi University
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1. Study Identification

Unique Protocol Identification Number
NCT01196585
Brief Title
Ultrasonography Guided Pleural Biopsy Versus Computed Tomography Guided Pleural Biopsy
Official Title
ULTRASONOGRAPHY GUIDED PLEURAL NEEDLE BIOPSY VERSUS COMPUTED TOMOGRAPHY GUIDED ABRAMS PLEURAL NEEDLE BIOPSY FOR DIAGNOSIS OF PATIENTS WITH PLEURAL EFFUSIONS: A RANDOMIZED CONTROLLED TRIAL
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Eskisehir Osmangazi University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pleural Diseases
Keywords
Pleura, biopsy, diagnosis, CT, ultrasonography

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients under CT- guided pleural biopsy
Arm Type
Experimental
Arm Description
Arm A: Patients who go under CT-guided pleural needle biopsy for pleural diseases
Arm Title
Patients under ultrasonography guided needle biopsy
Arm Type
Experimental
Arm Description
Arm B: Patients who go under ultrasonography guided cutting needle pleural biopsy for pleural diseases
Intervention Type
Procedure
Intervention Name(s)
CT-Guided pleural needle biopsy with Abrams' needle
Intervention Description
Patients will be randomized into two groups: Group A: CT-guided Abrams' needle biopsy.
Intervention Type
Procedure
Intervention Name(s)
Ultrasonography guided cutting pleural needle biopsy
Intervention Description
Patients will be randomized into two groups: Group B: Ultrasonography guided cutting-needle biopsy.
Primary Outcome Measure Information:
Title
To compare the sensitivities and specificities of two diagnostic methods for pleural diseases to establish which method is more effective.
Description
The investigators will determine which method more efficient for the diagnosis of pleural diseases establishing sensitivity and specificity of the methods. After establishment of sensitivity, specificity and side effects for each diagnostic method the investigators will compare them according to the method and determine which method is more efficient.
Time Frame
28-months
Secondary Outcome Measure Information:
Title
Number of participants with adverse events as a measure of safety and tolerability.
Description
All patients in both arm will be followed for complications of the diagnostic method. Complications experienced by the patients will be determined and recorded in special forms. Each complication will be measured with own characteristic such as pain, local infection, pneumothorax,local inavsion of disease, haemoragy etc.
Time Frame
28-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with exudative pleural effusion who require invasive procedure for diagnosis Exclusion Criteria: Patients without pleural effusion
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muzaffer Metintas, Professor
Organizational Affiliation
ESOGU Medical Faculty
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eskisehir Osmangazi University Medical Faculty department of Chest Diseases
City
Eskisehir
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
20154079
Citation
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.
Results Reference
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Ultrasonography Guided Pleural Biopsy Versus Computed Tomography Guided Pleural Biopsy

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