Ultrasonography Guided Pleural Biopsy Versus Computed Tomography Guided Pleural Biopsy
ULTRASONOGRAPHY GUIDED PLEURAL NEEDLE BIOPSY VERSUS COMPUTED TOMOGRAPHY GUIDED ABRAMS PLEURAL NEEDLE BIOPSY FOR DIAGNOSIS OF PATIENTS WITH PLEURAL EFFUSIONS: A RANDOMIZED CONTROLLED TRIAL
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2009
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 26, 2010
CompletedFirst Posted
Study publicly available on registry
September 8, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedMay 17, 2011
September 1, 2010
1.8 years
August 26, 2010
May 16, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
28-months
Secondary Outcomes (1)
Number of participants with adverse events as a measure of safety and tolerability.
28-months
Study Arms (2)
Patients under CT- guided pleural biopsy
EXPERIMENTALArm A: Patients who go under CT-guided pleural needle biopsy for pleural diseases
Patients under ultrasonography guided needle biopsy
EXPERIMENTALArm B: Patients who go under ultrasonography guided cutting needle pleural biopsy for pleural diseases
Interventions
Patients will be randomized into two groups: Group A: CT-guided Abrams' needle biopsy.
Patients will be randomized into two groups: Group B: Ultrasonography guided cutting-needle biopsy.
Eligibility Criteria
You may qualify if:
- Patients with exudative pleural effusion who require invasive procedure for diagnosis
You may not qualify if:
- Patients without pleural effusion
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Eskisehir Osmangazi University Medical Faculty department of Chest Diseases
Eskişehir, Turkey (Türkiye)
Related Publications (1)
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.
PMID: 20154079BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Muzaffer Metintas, Professor
ESOGU Medical Faculty
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 26, 2010
First Posted
September 8, 2010
Study Start
April 1, 2009
Primary Completion
January 1, 2011
Study Completion
April 1, 2011
Last Updated
May 17, 2011
Record last verified: 2010-09