Pleural DiseasesNCT01196585
Ultrasonography Guided Pleural Biopsy Versus Computed Tomography Guided Pleural Biopsy
A study testing CT-Guided pleural needle biopsy with Abrams' needle and Ultrasonography guided cutting pleural needle biopsy in people with Pleural Diseases, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Pleural Diseases
- What is being tested?
- CT-Guided pleural needle biopsy with Abrams' needle and Ultrasonography guided cutting pleural needle biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Apr 2009to Apr 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with exudative pleural effusion who require invasive procedure for diagnosis
Who cannot join
- Patients without pleural effusion
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Eskisehir Osmangazi University Medical Faculty department of Chest Diseases
Eskişehir
About this study
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
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.
Read the 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.
- Conditions
- Pleural Diseases
- Being tested
- CT-Guided pleural needle biopsy with Abrams' needle, Ultrasonography guided cutting pleural needle biopsy
- Keywords
- Pleura, biopsy, diagnosis, CT, ultrasonography
- Medical subject headings
- Pleural Diseases, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-Guided pleural needle biopsy with Abrams' needleProcedure or surgery
Patients will be randomized into two groups: Group A: CT-guided Abrams' needle biopsy.
Ultrasonography guided cutting pleural needle biopsyProcedure or surgery
Patients will be randomized into two groups: Group B: Ultrasonography guided cutting-needle biopsy.
| Study group | Role | What they receive |
|---|---|---|
| Patients under CT- guided pleural biopsy | Experimental | Arm A: Patients who go under CT-guided pleural needle biopsy for pleural diseases Receives: Procedure: CT-Guided pleural needle biopsy with Abrams' needle |
| Patients under ultrasonography guided needle biopsy | Experimental | Arm B: Patients who go under ultrasonography guided cutting needle pleural biopsy for pleural diseases Receives: Procedure: Ultrasonography guided cutting pleural needle biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28-months
Secondary outcomes (1)
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.
Measured: 28-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2010 (estimated)
- Study startApr 2009
- Primary completionJan 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pleural DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Investigators
- Muzaffer Metintas, Professor, Principal investigator, ESOGU Medical Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01196585
- Sponsor's protocol ID
- 082010/2
- Status last verified
- Sep 2010
- First submitted
- 26 Aug 2010
- Last updated
- 17 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20154079
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01196585
- Acronym / sponsor ID
- 082010/2
- Conditions
- Pleural Diseases
- Keywords
- Pleura, biopsy, diagnosis, CT, ultrasonography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 8 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients under CT- guided pleural biopsy | Experimental | Procedure: CT-Guided pleural needle biopsy with Abrams' needleArm A: Patients who go under CT-guided pleural needle biopsy for pleural diseases |
| Patients under ultrasonography guided needle biopsy | Experimental | Procedure: Ultrasonography guided cutting pleural needle biopsyArm B: Patients who go under ultrasonography guided cutting needle pleural biopsy for pleural diseases |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with exudative pleural effusion who require invasive procedure for diagnosis
Key exclusion criteria (1 listed)
- Patients without pleural effusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT-Guided pleural needle biopsy with Abrams' needlePatients will be randomized into two groups: Group A: CT-guided Abrams' needle biopsy. | Procedure or surgery | Patients under CT- guided pleural biopsy |
| Ultrasonography guided cutting pleural needle biopsyPatients will be randomized into two groups: Group B: Ultrasonography guided cutting-needle biopsy. | Procedure or surgery | Patients under ultrasonography guided needle biopsy |
Primary outcome
To compare the sensitivities and specificities of two diagnostic methods for pleural diseases to establish which method is more effective.
Time frame: 28-months
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.
1 secondary outcome
Number of participants with adverse events as a measure of safety and tolerability.
Time frame: 28-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2011.
- Background: PubMed 20154079Metintas 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muzaffer Metintas, Professor principal investigator
ESOGU Medical Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT-Guided pleural needle biopsy with Abrams' needle and Ultrasonography guided cutting pleural needle biopsy in people with Pleural Diseases, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the sensitivities and specificities of two diagnostic methods for pleural diseases to establish which method is more effective. (time frame: 28-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01196585, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2011.