Efficiency and Safety of Pleural Biopsy Methods in the Diagnosis of Pleural Diseases
Primary Purpose
Diagnosis of Pleural Diseases, Medical Thoracoscopy
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
CT-guided Abrams needle biopsy, US-guided cutting needle, medical thoracoscopy
Sponsored by
About this trial
This is an interventional diagnostic trial for Diagnosis of Pleural Diseases
Eligibility Criteria
Inclusion Criteria:
- Patients with pleural diseases
Exclusion Criteria:
- Patients with other lung diseases
Sites / Locations
- ESOGU Medical Faculty Department of Chest Diseases
- Eskisehir Osmangazi University Medical Faculty
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Diagnostic arm
Arm Description
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.
Outcomes
Primary Outcome Measures
Diagnostic efficiencies of pleural biopsy methods; CT-guided Abrams needle, US-guided cutting needle and medical thoracoscopy in the diagnosis of pleural diseases: The sensitivity, specificity, negative predictive value and positive predictive value.
The sensitivity, specificity, negative predictive value and positive predictive value of computed tomography guided Abrams needle pleural biopsy, ultrasonography guided cutting needle biopsy and medical thoracoscopy techniques in the diagnosis of pleural diseases.
Safety of pleural biopsy methods; CT-guided Abrams needle, US-guided cutting needle and medical thoracoscopy in the diagnosis of pleural diseases: Rate of side effects.
Rate of side effects comparing to each other for computed tomography guided Abrams needle pleural biopsy, ultrasonography guided cutting needle biopsy and medical thoracoscopy techniques in the diagnosis of pleural diseases.
Secondary Outcome Measures
Full Information
NCT ID
NCT03153501
First Posted
May 4, 2017
Last Updated
May 12, 2017
Sponsor
Eskisehir Osmangazi University
1. Study Identification
Unique Protocol Identification Number
NCT03153501
Brief Title
Efficiency and Safety of Pleural Biopsy Methods in the Diagnosis of Pleural Diseases
Official Title
How Should be Invasive Diagnostic Algorithm in Pleural Diseases
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
February 8, 2011 (Actual)
Primary Completion Date
February 1, 2017 (Actual)
Study Completion Date
April 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eskisehir Osmangazi University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diagnosis of Pleural Diseases, Medical Thoracoscopy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
Image guided biopsies Thoracoscopy
Allocation
N/A
Enrollment
164 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diagnostic arm
Arm Type
Other
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
CT-guided Abrams needle biopsy, US-guided cutting needle, medical thoracoscopy
Primary Outcome Measure Information:
Title
Diagnostic efficiencies of pleural biopsy methods; CT-guided Abrams needle, US-guided cutting needle and medical thoracoscopy in the diagnosis of pleural diseases: The sensitivity, specificity, negative predictive value and positive predictive value.
Description
The sensitivity, specificity, negative predictive value and positive predictive value of computed tomography guided Abrams needle pleural biopsy, ultrasonography guided cutting needle biopsy and medical thoracoscopy techniques in the diagnosis of pleural diseases.
Time Frame
5 years
Title
Safety of pleural biopsy methods; CT-guided Abrams needle, US-guided cutting needle and medical thoracoscopy in the diagnosis of pleural diseases: Rate of side effects.
Description
Rate of side effects comparing to each other for computed tomography guided Abrams needle pleural biopsy, ultrasonography guided cutting needle biopsy and medical thoracoscopy techniques in the diagnosis of pleural diseases.
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with pleural diseases
Exclusion Criteria:
Patients with other lung diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muzaffer Metintas, MD
Organizational Affiliation
ESOGU Medical Faculty
Official's Role
Principal Investigator
Facility Information:
Facility Name
ESOGU Medical Faculty Department of Chest Diseases
City
Eskisehir
State/Province
Meselik - Eskisehir
ZIP/Postal Code
26040
Country
Turkey
Facility Name
Eskisehir Osmangazi University Medical Faculty
City
Eskişehir
ZIP/Postal Code
26040
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28416960
Citation
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.
Results Reference
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Learn more about this trial
Efficiency and Safety of Pleural Biopsy Methods in the Diagnosis of Pleural Diseases
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