Diagnosis of Pleural DiseasesNCT05428891
Image-guided Pleural Biopsy or Medical Thoracosocopy in Diagnosis of Pleural Disease
A study testing Abrams' needle pleural biopsy (IG-ANPB) versus medical thoracoscopy in the diagnosis of pleural diseases. in people with Diagnosis of Pleural Diseases, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Diagnosis of Pleural Diseases
- What is being tested?
- Abrams' needle pleural biopsy (IG-ANPB) versus medical thoracoscopy in the diagnosis of pleural diseases.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Apr 2017to 1 May 2022
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pleural effusion Malignant pleural diseases Pleurisy tuberculosis Benign pleural diseases
Who cannot join
- Age less than 18 years, Parapneumonic effusion, Presence of other systemic diseases that could interfere radiological evaluation.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Eskisehir Osmangazi University Medical Faculty Department of Chest Diseases
Eskişehir, Tepebaşı, 260140
About this study
Official title: Image-guided Pleural Needle Biopsy or Medical Thoracoscopy: Which Method for Which Patient? A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Diagnosis of Pleural Diseases
- Being tested
- Abrams' needle pleural biopsy (IG-ANPB) versus medical thoracoscopy in the diagnosis of pleural diseases.
- Keywords
- Pleura, Thoracoscopy, Pleural needle biopsy, Diagnosis
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abrams' needle pleural biopsy (IG-ANPB) versus medical thoracoscopy in the diagnosis of pleural diseases.Procedure or surgery
Also called A diagnostic algorithm for pleural diseases.
We compare the diagnostic efficacy and safety of imaging-guided Abrams needle biopsy with medical thoracoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Only pleural effusion | Other | The patients with only pleural effusion on their CT scans. Receives: Procedure: Abrams' needle pleural biopsy (IG-ANPB) versus medical thoracoscopy in the diagnosis of pleural diseases. |
| Pleural effusion associated with pleural thickening or any other lesion like mass or nodules. | Other | The patients with pleural effusion associated with pleural thickening or any other lesion-like mass or nodules on their CT scans. Receives: Procedure: Abrams' needle pleural biopsy (IG-ANPB) versus medical thoracoscopy in the diagnosis of pleural diseases. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2022
- Study start30 Apr 2017
- Primary completion27 Feb 2022
- Study completion1 May 2022
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 Diagnosis of 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
- Model description
- Randomized prospective
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muzaffer Metintas, Eskisehir Osmangazi University
- Investigators
- Muzaffer Metintas, Prof., Principal investigator, Eskisehir Osmangazi University Medical Faculty Department of Chest Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05428891
- Sponsor's protocol ID
- 80558721/162
- Status last verified
- Sep 2023
- First submitted
- 15 Jun 2022
- Last updated
- 11 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Metintas M, Ak G, Yildirim H, Dundar E, Aydin N, Erginel S, Alatas F, Yilmaz S, Metintas S. Image-Assisted Pleural Needle Biopsy or Medical Thoracoscopy: Which Method for Which Patient? A Randomized Controlled Trial. Chest. 2024 Aug;166(2):405-412. doi: 10.1016/j.chest.2024.03.038. Epub 2024 Mar 28.
PubMed 38554817
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Image-guided Pleural Needle Biopsy or Medical Thoracoscopy: Which Method for Which Patient? A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05428891
- Acronym / sponsor ID
- 80558721/162
- Conditions
- Diagnosis of Pleural Diseases
- Keywords
- Pleura, Thoracoscopy, Pleural needle biopsy, Diagnosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- 30 Apr 2017 (actual)
- Primary completion
- 27 Feb 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 23 Jun 2022 (actual)
- 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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized prospective
| Arm | Type | Receives |
|---|---|---|
| Only pleural effusion | Other | Procedure: Abrams' needle pleural biopsy (IG-ANPB) versus medical thoracoscopy in the diagnosis of pleural diseases.The patients with only pleural effusion on their CT scans. |
| Pleural effusion associated with pleural thickening or any other lesion like mass or nodules. | Other | Procedure: Abrams' needle pleural biopsy (IG-ANPB) versus medical thoracoscopy in the diagnosis of pleural diseases.The patients with pleural effusion associated with pleural thickening or any other lesion-like mass or nodules on their CT scans. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Pleural effusion Malignant pleural diseases Pleurisy tuberculosis Benign pleural diseases
Key exclusion criteria (1 listed)
- Age less than 18 years, Parapneumonic effusion, Presence of other systemic diseases that could interfere radiological evaluation.
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 |
|---|---|---|
| Abrams' needle pleural biopsy (IG-ANPB) versus medical thoracoscopy in the diagnosis of pleural diseases.Also: A diagnostic algorithm for pleural diseases.We compare the diagnostic efficacy and safety of imaging-guided Abrams needle biopsy with medical thoracoscopy. | Procedure or surgery | Only pleural effusion, Pleural effusion associated with pleural thickening or any other lesion like mass or nodules. |
Primary outcome
The efficacy of pleural biopsy methods for the diagnosis of pleural diseases.
Time frame: 60 months
To compare the diagnostic efficacy and safety of imaging-guided Abrams needle biopsy with medical thoracoscopy.
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 11 Sep 2023.
- Derived from this study: PubMed 38554817Metintas M, Ak G, Yildirim H, Dundar E, Aydin N, Erginel S, Alatas F, Yilmaz S, Metintas S. Image-Assisted Pleural Needle Biopsy or Medical Thoracoscopy: Which Method for Which Patient? A Randomized Controlled Trial. Chest. 2024 Aug;166(2):405-412. doi: 10.1016/j.chest.2024.03.038. Epub 2024 Mar 28.
- Individual participant dataSharing planned: No
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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, Prof. principal investigator
Eskisehir Osmangazi University Medical Faculty Department of Chest Diseases
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abrams' needle pleural biopsy (IG-ANPB) versus medical thoracoscopy in the diagnosis of pleural diseases. in people with Diagnosis of 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 11 Sep 2023. 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?
The efficacy of pleural biopsy methods for the diagnosis of pleural diseases. (time frame: 60 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 NCT05428891, 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 11 Sep 2023.