Image-guided Pleural Biopsy or Medical Thoracosocopy in Diagnosis of Pleural Disease
Primary Purpose
Diagnosis of Pleural Diseases
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Abrams' needle pleural biopsy (IG-ANPB) versus medical thoracoscopy in the diagnosis of pleural diseases.
Sponsored by
About this trial
This is an interventional diagnostic trial for Diagnosis of Pleural Diseases focused on measuring Pleura, Thoracoscopy, Pleural needle biopsy, Diagnosis
Eligibility Criteria
Inclusion Criteria:
Pleural effusion Malignant pleural diseases Pleurisy tuberculosis Benign pleural diseases
Exclusion Criteria:
Age less than 18 years, Parapneumonic effusion, Presence of other systemic diseases that could interfere radiological evaluation.
Sites / Locations
- Eskisehir Osmangazi University Medical Faculty Department of Chest Diseases
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Only pleural effusion
Pleural effusion associated with pleural thickening or any other lesion like mass or nodules.
Arm Description
The patients with only pleural effusion on their CT scans.
The patients with pleural effusion associated with pleural thickening or any other lesion-like mass or nodules on their CT scans.
Outcomes
Primary Outcome Measures
The efficacy of pleural biopsy methods for the diagnosis of pleural diseases.
To compare the diagnostic efficacy and safety of imaging-guided Abrams needle biopsy with medical thoracoscopy.
Secondary Outcome Measures
Full Information
NCT ID
NCT05428891
First Posted
June 15, 2022
Last Updated
September 7, 2023
Sponsor
Eskisehir Osmangazi University
1. Study Identification
Unique Protocol Identification Number
NCT05428891
Brief Title
Image-guided Pleural Biopsy or Medical Thoracosocopy in Diagnosis of Pleural Disease
Official Title
Image-guided Pleural Needle Biopsy or Medical Thoracoscopy: Which Method for Which Patient? A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
April 30, 2017 (Actual)
Primary Completion Date
February 27, 2022 (Actual)
Study Completion Date
May 1, 2022 (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
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Pleural diseases can occur due to numerous pathological conditions. The increasing prevalence of etiologic causes and aging population worldwide will make pleural diseases a growing problem in the coming years. As a result of this increase, the need for diagnostic investigations is also increasing. In recent years, the use of image-guided needle biopsies under ultrasound (US) or computed tomography (CT) and the increasing use of medical thoracoscopy (MT) have significantly increased the accuracy of diagnosis of pleural disease. There is not yet a generally accepted algorithm for invasive diagnosis of pleural disease, widely used in clinics, that determines which method should be used in which patient. It would be necessary and valuable to develop an algorithm based on imaging findings in particular to improve the diagnostic accuracy, safety, and cost of the procedure. The investigators aimed to test the algorithm in an interventional study to increase the level of evidence in this study.
Detailed Description
No consensus exists regarding which biopsy methods are appropriate for specific procedures. In this randomized prospective study, the investigators aimed to compare image guided - pleural biopsy using an Abrams' needle (IG-ANPB) with medical thoracoscopy (MT) according to the CT findings of the patients concerning both diagnostic yield and safety.
Between May 2017 and March 2022, 228 patients with exudative pleural effusion who the cytological analysis could not diagnose were included. All patients were separated into two groups regarding the CT findings: Only pleural effusion or pleural effusion with pleural thickening/lesion. In each group, the patients were randomized to either underwent IG-ANPB or underwent MT. The two groups were compared in terms of diagnostic sensitivity, accuracy, and complications.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diagnosis of Pleural Diseases
Keywords
Pleura, Thoracoscopy, Pleural needle biopsy, Diagnosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized prospective
Masking
Participant
Masking Description
Participants do not know which method will apply.
Allocation
Randomized
Enrollment
228 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Only pleural effusion
Arm Type
Other
Arm Description
The patients with only pleural effusion on their CT scans.
Arm Title
Pleural effusion associated with pleural thickening or any other lesion like mass or nodules.
Arm Type
Other
Arm Description
The patients with pleural effusion associated with pleural thickening or any other lesion-like mass or nodules on their CT scans.
Intervention Type
Procedure
Intervention Name(s)
Abrams' needle pleural biopsy (IG-ANPB) versus medical thoracoscopy in the diagnosis of pleural diseases.
Other Intervention Name(s)
A diagnostic algorithm for pleural diseases.
Intervention Description
We compare the diagnostic efficacy and safety of imaging-guided Abrams needle biopsy with medical thoracoscopy.
Primary Outcome Measure Information:
Title
The efficacy of pleural biopsy methods for the diagnosis of pleural diseases.
Description
To compare the diagnostic efficacy and safety of imaging-guided Abrams needle biopsy with medical thoracoscopy.
Time Frame
60 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Pleural effusion Malignant pleural diseases Pleurisy tuberculosis Benign pleural diseases
Exclusion Criteria:
Age less than 18 years, Parapneumonic effusion, Presence of other systemic diseases that could interfere radiological evaluation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muzaffer Metintas, Prof.
Organizational Affiliation
Eskisehir Osmangazi University Medical Faculty Department of Chest Diseases
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eskisehir Osmangazi University Medical Faculty Department of Chest Diseases
City
Eskisehir
State/Province
Tepebaşı
ZIP/Postal Code
260140
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Image-guided Pleural Biopsy or Medical Thoracosocopy in Diagnosis of Pleural Disease
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