Pleural EffusionNCT00720954
Rigid Thoracoscopy Versus CT-Guided Pleural Needle Biopsy
A study testing Ct-guided pleural needle biopsy and Thoracoscopy in people with Pleural Effusion and Pleural Diseases, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to compare the rigid thoracoscopy with CT-guided pleural needle biopsy by the diagnostic efficacy and safety in patients with pleural effusion. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pleural Effusion, Pleural Diseases
- What is being tested?
- Ct-guided pleural needle biopsy and Thoracoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2006to Jun 2008
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages between 18-85
- Pleural effusion in conventional radiography
- At least 10x10 cm space in pleural space with effusion
- No bleeding diathesis
- Informed consent
Who cannot join
- Patients who went under pleural biopsy before
- Arrythmia
- Hypertensive attack during biopsy
- Bleeding diathesis
- Hypoxemia
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
ESOGU MEDICAL FACULTY DEPARTMENT of CHEST DISEASES
Eskişehir, 26220
About this study
Official title: Rigid Thoracoscopy Versus CT-Guided Pleural Needle Biopsy For Diagnosis of Patients With Pleural Effusions: A Randomized Control Trial
The aim of this study is to compare the rigid thoracoscopy with CT-guided pleural needle biopsy by the diagnostic efficacy and safety in patients with pleural effusion.
Read the detailed description
Pleural needle biopsy with Abrams needle, which can be performed by all chest physicians, is a simple, safe and cheap method of obtaining tissue from pleura, but its diagnostic rate is between 7 % -72 %, ~ 50 %. Problems for Abrams needle are scattered tumoral involvement on pleura, blind performance, small tissue sampling, to tend to early and dense fibrosis and usually involvement of lower pleural surface and diaphragmatic pleura.
Pleural needle biopsy with Abrams' needle, which can be performed by all chest physicians, if done with image guided and if this increase the diagnosis rate, the number of second procedure which is more expensive and hard will decrease.
The study aims the comparison of rigid thoracoscopy with CT-guided pleural needle biopsy by the diagnostic efficacy and safety in patients with pleural effusion.
It has been planned that a total of 120 patients accepted to the study who have pleural effusion at plain chest roentgenogram. All patients are being randomized after underwent contrast-enhanced CT. Undiagnosed patients of biopsy group are performed thoracoscopy and undiagnosed patients of thoracoscopy group followed up.
Two groups will compare by age, sex, Karnofsky performance status (KPS), diagnosis and complication rate.
- Conditions
- Pleural Effusion, Pleural Diseases
- Being tested
- Ct-guided pleural needle biopsy, Thoracoscopy
- Keywords
- Thoracoscopy, Pleural needle biopsy, Malignant pleural diseases, Mesothelioma, Diagnosis, Pleurisy tuberculosis, Patients with pleural diseases and pleural effusion should have been included in the study.
- Medical subject headings
- Pleural Effusion, Pleural Diseases, Mesothelioma, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ct-guided pleural needle biopsyProcedure or surgery
Also called Diagnose
Biopsy of pleura
ThoracoscopyProcedure or surgery
Also called Diagnose
Biopsy of pleura
| Study group | Role | What they receive |
|---|---|---|
| A | Other | CT guided pleural needle biopsy Receives: Procedure: Ct-guided pleural needle biopsy |
| B | Other | Thoracoscopy Receives: Procedure: Thoracoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy and safety of both thoracoscopy and CT-guided pleural needle biopsy for diagnosis of pleural diseases
Measured: 30 months
Secondary outcomes (1)
Determine the efficacy of pleural needle biopsy and thoracoscopy in relation to CT findings.
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2008 (estimated)
- Study startJan 2006
- Primary completionJun 2008
- Study completionJun 2008
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 EffusionStudies 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
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00720954
- Sponsor's protocol ID
- 2007.11.008
- Status last verified
- Jul 2008
- First submitted
- 21 Jul 2008
- Last updated
- 23 Jul 2008
- Results posted
- No
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 23 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rigid Thoracoscopy Versus CT-Guided Pleural Needle Biopsy For Diagnosis of Patients With Pleural Effusions: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT00720954
- Acronym / sponsor ID
- 2007.11.008
- Conditions
- Pleural Effusion, Pleural Diseases
- Keywords
- Thoracoscopy, Pleural needle biopsy, Malignant pleural diseases, Mesothelioma, Diagnosis, Pleurisy tuberculosis, Patients with pleural diseases and pleural effusion should have been included in the study.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 23 Jul 2008 (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.
The aim of this study is to compare the rigid thoracoscopy with CT-guided pleural needle biopsy by the diagnostic efficacy and safety in patients with pleural effusion.
Detailed description
Pleural needle biopsy with Abrams needle, which can be performed by all chest physicians, is a simple, safe and cheap method of obtaining tissue from pleura, but its diagnostic rate is between 7 % -72 %, ~ 50 %. Problems for Abrams needle are scattered tumoral involvement on pleura, blind performance, small tissue sampling, to tend to early and dense fibrosis and usually involvement of lower pleural surface and diaphragmatic pleura.
Pleural needle biopsy with Abrams' needle, which can be performed by all chest physicians, if done with image guided and if this increase the diagnosis rate, the number of second procedure which is more expensive and hard will decrease.
The study aims the comparison of rigid thoracoscopy with CT-guided pleural needle biopsy by the diagnostic efficacy and safety in patients with pleural effusion.
It has been planned that a total of 120 patients accepted to the study who have pleural effusion at plain chest roentgenogram. All patients are being randomized after underwent contrast-enhanced CT. Undiagnosed patients of biopsy group are performed thoracoscopy and undiagnosed patients of thoracoscopy group followed up.
Two groups will compare by age, sex, Karnofsky performance status (KPS), diagnosis and complication rate.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Other | Procedure: Ct-guided pleural needle biopsyCT guided pleural needle biopsy |
| B | Other | Procedure: ThoracoscopyThoracoscopy |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ages between 18-85
- Pleural effusion in conventional radiography
- At least 10x10 cm space in pleural space with effusion
- No bleeding diathesis
- Informed consent
Key exclusion criteria (5 listed)
- Patients who went under pleural biopsy before
- Arrythmia
- Hypertensive attack during biopsy
- Bleeding diathesis
- Hypoxemia
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 biopsyAlso: DiagnoseBiopsy of pleura | Procedure or surgery | A |
| ThoracoscopyAlso: DiagnoseBiopsy of pleura | Procedure or surgery | B |
Primary outcome
Efficacy and safety of both thoracoscopy and CT-guided pleural needle biopsy for diagnosis of pleural diseases
Time frame: 30 months
1 secondary outcome
Determine the efficacy of pleural needle biopsy and thoracoscopy in relation to CT findings.
Time frame: 30 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 23 Jul 2008.
- Derived from this study: 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.
- UniversityLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Thoracoscopy in people with Pleural Effusion and 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 5 inclusion and 5 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 23 Jul 2008. 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?
Efficacy and safety of both thoracoscopy and CT-guided pleural needle biopsy for diagnosis of pleural diseases (time frame: 30 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 NCT00720954, 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 23 Jul 2008.