search
Back to results

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
Eskisehir Osmangazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Diagnosis of Pleural Diseases

Eligibility Criteria

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

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

First Posted
May 4, 2017
Last Updated
May 12, 2017
Sponsor
Eskisehir Osmangazi University
search

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
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs