Pleural DiseasesNCT01356979
Outcome of Patients Undiagnosed Under Medical Thoracoscopy
An observational study of Pleural Diseases, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
Trial summary
Medical thoracoscopy (MT) under local anaesthetic and mild sedation, an established method in the diagnosis of pleural diseases. MT has an overall diagnostic yield above 90% for malignant pleural diseases and pleural tuberculosis. However, others who are diagnosed as fibrinous pleuritis make confusion in clinicians. 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?
- Medical thoracoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 355 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Feb 2002to Jun 2009
- Phase
- Observational
- 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
Study population: The patients with undiagnosed exudative pelural effusion by clinical, radiological or laboratory investigations.
Who may be able to join
- Undiagnosed exudative pleural effusion
- Under 20 years-old, over 85 years-old
- Followed 2 years at least
Who cannot join
- Transudative pleural effusion
- Patients who do not accepted medical thoracoscopy.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
ESOGU Medical Faculty Department of Chest Diseases
Eskişehir, Meselik - Eskisehir, 26040
About this study
Official title: Outcome of Patients Who Could Not Have Been Diagnosed by Medical Thoracoscopy
Medical thoracoscopy (MT) under local anaesthetic and mild sedation, an established method in the diagnosis of pleural diseases. MT has an overall diagnostic yield above 90% for malignant pleural diseases and pleural tuberculosis. However, others who are diagnosed as fibrinous pleuritis make confusion in clinicians. Whether these patients are firmly followed or not ? The investigators do not know the answer of this question.
In this study the investigators aimed to investigate the outcome of the patients who are diagnosed as fibrinous pleuritis on MT biopsies.
Read the detailed description
Medical thoracoscopy (MT) under local anaesthetic and mild sedation, an established method in the diagnosis of pleural diseases with a sensitivity above 90% and specificity of 1000% for malignant pleural diseases and pleural tuberculosis. Except these two groups of patients, in others pleural histopathological diagnosis is defined as "non-specific pleuritis" or "fibrinous pleuritis". Authors say that the natural evolution of these patients is poorly understood. Some of these patients was later established false negative cases for malignant pleural diseases. Clinical guidelines recommend close observation of patients with undiagnosed exudative effusions, although the length and follow-up regime is not defined, yet. In this study the investigators examine the outcome of patients who are diagnosed as fibrinous pleuritis by MT.
- Conditions
- Pleural Diseases
- Being tested
- Medical thoracoscopy
- Keywords
- Medical thoracoscopy, Pleural effusion, Malignant pleural diseases, Tuberculous pleuritis, Fibrinous pleuritis
- Medical subject headings
- Pleural Diseases, Pleural Effusion, Tuberculosis, Pleural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical thoracoscopyProcedure or surgery
Also called Rigid thoracoscopy for diagnosis of pleural diseases
Performing medical thoracoscopy to diagnose pleural diseases after cytological and other investigational tests.
| Study group | Role | What they receive |
|---|---|---|
| Patients underwent medical thoracoscopy | Patients who require medical thoracoscopy for undiagnosed exudative pleural effusion by other clinical or radiological investigations. Receives: Procedure: Medical thoracoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of medical thoracoscopy for patients diagnosed as fibrinous pleuritis.
During 2 years after medical thoracoscopy, the diagnostic sensitivity, specificity, positive predictive value and negative predictive value are determined in the patients diagnosed as fibrinous pleuritis.
Measured: 2 years
Secondary outcomes (1)
To determine the factors which point the false positive diagnosis of fibrinous pleuritis.
The factors predictive of false-negative biopsy results in the patients with a diagnosis of fibrinous pleuritis are determined by using logistic regression analysis .
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2011 (estimated)
- Study startFeb 2002
- Primary completionMay 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 355 participants (estimated)
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, MD, Principal investigator, ESOGU Medical Faculty Department of Chest Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01356979
- Sponsor's protocol ID
- 052011/15
- Status last verified
- Sep 2012
- First submitted
- 16 May 2011
- Last updated
- 25 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Patients Who Could Not Have Been Diagnosed by Medical Thoracoscopy
- ClinicalTrials.gov ID
- NCT01356979
- Acronym / sponsor ID
- 052011/15
- Conditions
- Pleural Diseases
- Keywords
- Medical thoracoscopy, Pleural effusion, Malignant pleural diseases, Tuberculous pleuritis, Fibrinous pleuritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 355 participants (estimated)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- Feb 2002
- Primary completion
- May 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 20 May 2011 (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.
Medical thoracoscopy (MT) under local anaesthetic and mild sedation, an established method in the diagnosis of pleural diseases. MT has an overall diagnostic yield above 90% for malignant pleural diseases and pleural tuberculosis. However, others who are diagnosed as fibrinous pleuritis make confusion in clinicians. Whether these patients are firmly followed or not ? The investigators do not know the answer of this question.
In this study the investigators aimed to investigate the outcome of the patients who are diagnosed as fibrinous pleuritis on MT biopsies.
Detailed description
Medical thoracoscopy (MT) under local anaesthetic and mild sedation, an established method in the diagnosis of pleural diseases with a sensitivity above 90% and specificity of 1000% for malignant pleural diseases and pleural tuberculosis. Except these two groups of patients, in others pleural histopathological diagnosis is defined as "non-specific pleuritis" or "fibrinous pleuritis". Authors say that the natural evolution of these patients is poorly understood. Some of these patients was later established false negative cases for malignant pleural diseases. Clinical guidelines recommend close observation of patients with undiagnosed exudative effusions, although the length and follow-up regime is not defined, yet. In this study the investigators examine the outcome of patients who are diagnosed as fibrinous pleuritis by MT.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients underwent medical thoracoscopy | – | Procedure: Medical thoracoscopyPatients who require medical thoracoscopy for undiagnosed exudative pleural effusion by other clinical or radiological investigations. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients with undiagnosed exudative pelural effusion by clinical, radiological or laboratory investigations.
Key inclusion criteria (3 listed)
- Undiagnosed exudative pleural effusion
- Under 20 years-old, over 85 years-old
- Followed 2 years at least
Key exclusion criteria (2 listed)
- Transudative pleural effusion
- Patients who do not accepted medical thoracoscopy.
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 |
|---|---|---|
| Medical thoracoscopyAlso: Rigid thoracoscopy for diagnosis of pleural diseasesPerforming medical thoracoscopy to diagnose pleural diseases after cytological and other investigational tests. | Procedure or surgery | Patients underwent medical thoracoscopy |
Primary outcome
Accuracy of medical thoracoscopy for patients diagnosed as fibrinous pleuritis.
Time frame: 2 years
During 2 years after medical thoracoscopy, the diagnostic sensitivity, specificity, positive predictive value and negative predictive value are determined in the patients diagnosed as fibrinous pleuritis.
1 secondary outcome
To determine the factors which point the false positive diagnosis of fibrinous pleuritis.
Time frame: 2 years
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 25 Sep 2012.
Related trials for Pleural Diseases
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
Study of the Disease Process of Lymphangioleiomyomatosis
Lung Disease, Pneumothorax
RecruitingObservational study
Genetic Analysis of Birt Hogg-Dube Syndrome and Characterization of Predisposition to Kidney Cancer
Kidney Neoplasms, Kidney Cancer
RecruitingPhase 1/2
Efficacy and Safety of Ivonescimab Plus Pemetrexed and Platinum-Based Chemotherapy in Advanced Malignant Pleural Mesothelioma
Malignant Pleural Mesothelioma, Advanced
RecruitingPhase 2
The Diagnostic Accuracy and Clinical Value of FAPI PET in Pleural Mesothelioma
Pleural Mesothelioma, Pleural Diseases
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, MD principal investigator
ESOGU 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?
An observational study 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 3 inclusion and 2 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 25 Sep 2012. 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?
Accuracy of medical thoracoscopy for patients diagnosed as fibrinous pleuritis. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Sep 2012.