Pleural DiseasesNCT01193439
Safety of Thoracoscopy in Patients With High Risk
An observational study of Pleural Diseases, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
Trial summary
Medical thoracoscopy can be performed for diagnostic as well as therapeutic purposes. Thoracoscopy in the diagnosis of pleural diseases is highly sensitive for detecting pleural neoplasia with negative pleural fluid cytology and in the diagnosis of tuberculosis. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Pleural Diseases
- How many people
- 355 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2002to Dec 2010
- 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: Patients who require thoracoscpic investigation
Who may be able to join
- Patients with exudative pleural effusion
Who cannot join
- Patients without pleural effusion
Trial locations and contacts
1 site in 1 country.
About this study
Medical thoracoscopy can be performed for diagnostic as well as therapeutic purposes. Thoracoscopy in the diagnosis of pleural diseases is highly sensitive for detecting pleural neoplasia with negative pleural fluid cytology and in the diagnosis of tuberculosis. The indication of thoracoscopy in patients with pleural effusion has been optimized. In some studies medical thoracoscopy has been claimed a useful diagnostic tool with a very low rate of complications. However the investigators do not know its safety on high risk patients. Because many patients having suspected malignancy have bed conditions due to other health problems such as coronary heart diseases, COPD, arrythmia, hypoxemia. In this study the investigators aimed to test the safety of medical thoracoscopy in the patients with high risk for complications.
- Conditions
- Pleural Diseases
- Keywords
- thoracoscopy, pleural diseases, complications, safety
- Medical subject headings
- Pleural Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with high risk | Not described | |
| Patients in normal conditions | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
All participants will have been followed for side effects of medical thoracoscopy. All side effects established in the special forms designed for this study. Side effects measured and recorded according to each characteristic such as pain, air leakege, pneumothorax, empyema, local infection, haemorragy etc.
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2010 (estimated)
- Study startJan 2002
- Primary completionJan 2009
- Study completionDec 2010
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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 355 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, Professor, Principal investigator, Head of Department, Professor of pulmonary medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01193439
- Sponsor's protocol ID
- 082010/1
- Status last verified
- Sep 2012
- First submitted
- 26 Aug 2010
- Last updated
- 25 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rodriguez-Panadero F. Medical thoracoscopy. Respiration. 2008;76(4):363-72. doi: 10.1159/000158545. Epub 2008 Nov 12.
PubMed 19018161
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
- Safety of Thoracoscopy in Patients With High Risk
- ClinicalTrials.gov ID
- NCT01193439
- Acronym / sponsor ID
- 082010/1
- Conditions
- Pleural Diseases
- Keywords
- thoracoscopy, pleural diseases, complications, safety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 355 participants (actual)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- Jan 2002
- Primary completion
- Jan 2009 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 2 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.
Medical thoracoscopy can be performed for diagnostic as well as therapeutic purposes. Thoracoscopy in the diagnosis of pleural diseases is highly sensitive for detecting pleural neoplasia with negative pleural fluid cytology and in the diagnosis of tuberculosis. The indication of thoracoscopy in patients with pleural effusion has been optimized. In some studies medical thoracoscopy has been claimed a useful diagnostic tool with a very low rate of complications. However the investigators do not know its safety on high risk patients. Because many patients having suspected malignancy have bed conditions due to other health problems such as coronary heart diseases, COPD, arrythmia, hypoxemia. In this study the investigators aimed to test the safety of medical thoracoscopy in the patients with high risk for complications.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with high risk | – | – |
| Patients in normal conditions | – | – |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who require thoracoscpic investigation
Key inclusion criteria (1 listed)
- Patients with exudative pleural effusion
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.
Primary outcome
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 6 years
All participants will have been followed for side effects of medical thoracoscopy. All side effects established in the special forms designed for this study. Side effects measured and recorded according to each characteristic such as pain, air leakege, pneumothorax, empyema, local infection, haemorragy etc.
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.
- Background: PubMed 19018161Rodriguez-Panadero F. Medical thoracoscopy. Respiration. 2008;76(4):363-72. doi: 10.1159/000158545. Epub 2008 Nov 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
Head of Department, Professor of pulmonary medicine
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 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 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?
Number of Participants with Adverse Events as a Measure of Safety and Tolerability (time frame: 6 years). 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 NCT01193439, 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 25 Sep 2012.